Name (Synonyms) | Correlation | |
---|---|---|
drug507 | Caffeine 200 mg Wiki | 0.41 |
drug2427 | TERA Intervention Wiki | 0.41 |
drug44 | 50 mg/mL Virazole Wiki | 0.41 |
drug2157 | SKILLZ-Girl Enhanced football curriculum Wiki | 0.41 |
drug1680 | Omeprazole 40 mg Wiki | 0.41 |
drug4 | 0.12% Chlorhexidine oral/nasal rinse Wiki | 0.41 |
drug2181 | Saline oral/nasal rinse Wiki | 0.41 |
drug89 | ATV Wiki | 0.41 |
drug1486 | Metoprolol 100 mg Wiki | 0.41 |
drug307 | BR Wiki | 0.41 |
drug14 | 14C-lazertinib Wiki | 0.41 |
drug981 | GSK3640254 200 mg Wiki | 0.41 |
drug1491 | Midazolam 5 mg (2.5 mL) Wiki | 0.41 |
drug705 | DRV Wiki | 0.41 |
drug6 | 0.5% Povidone/Iodine oral/nasal rinse Wiki | 0.41 |
drug772 | Digoxin 0.25 mg Wiki | 0.41 |
drug955 | Flurbiprofen 100 mg Wiki | 0.41 |
drug13 | 100 mg/mL Virazole Wiki | 0.41 |
drug1517 | Montelukast 10 mg Wiki | 0.41 |
drug1892 | Pravastatin 40 mg Wiki | 0.41 |
drug594 | Cobicistat Wiki | 0.41 |
drug1613 | No intervention Wiki | 0.10 |
drug2319 | Standard of Care Wiki | 0.08 |
Name (Synonyms) | Correlation | |
---|---|---|
D000163 | Acquired Immunodeficiency Syndrome NIH | 0.71 |
D007153 | Immunologic Deficiency Syndromes NIH | 0.17 |
D003141 | Communicable Diseases NIH | 0.04 |
D007239 | Infection NIH | 0.02 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
D018352 | Coronavirus Infections NIH | 0.02 |
There are 6 clinical trials
Cohort 1: The primary objectives are: - To evaluate the steady-state pharmacokinetics (PK) of Atazanavir (ATV) and Darunavir (DRV) and confirm the dose of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) in HIV-1 infected, virologically suppressed adolescent participants weighing ≥ 25 kg (12 to < 18 years of age) - To evaluate the safety and tolerability of ATV/co or DRV/co through 24 weeks in HIV-1 infected, virologically suppressed adolescent participants weighing ≥ 25 kg (12 to < 18 years of age) Cohort 2: The primary objectives are: - To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) - To evaluate the steady-state PK of tenofovir alafenamide (TAF) and confirm the dose of emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) - To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) Cohort 3: The primary objectives are: - To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age) - To evaluate the steady-state PK of TAF and confirm the dose of F/TAF in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age) - To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age)
Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measure: Pharmacokinetic (PK) Parameter: AUCtau of ATV and DRV Time: Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measure: Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, and TAF for Cohorts 2 and 3 Time: Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measure: PK Parameter: Ctau of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).Description: Cmax is defined as the maximum observed concentration of drug.
Measure: PK Parameter: Cmax of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).Description: CL/F is defined as the apparent oral clearance following administration of the drug.
Measure: PK Parameter: CL/F of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).Description: Vz/F is defined as the apparent volume of distribution of the drug.
Measure: PK Parameter: Vz/F of COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measure: PK Parameter: Ctau of ATV, DRV, COBI, FTC, and TFV for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48Description: Cmax is defined as the maximum observed concentration of drug.
Measure: PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48Description: CL/F is defined as the apparent oral clearance following administration of the drug.
Measure: PK Parameter: CL/F of ATV, DRV, and TAF for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48Description: Vz/F is defined as the apparent volume of distribution of the drug.
Measure: PK Parameter: Vz/F of COBI and TAF for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment options. To date however, there are few demonstrated interventions for youth failing first line therapy. This study will evaluate a novel intervention that uses remote coaching through video enabled counseling sessions, a 'smart' pill bottle that notifies an adherence coach when youth fail to open/close the device around dose time, and problem solving outreach by the coach when and as needed. This intensive 'boot camp' strategy is implemented for 12 weeks followed by observation through 48 weeks.
Description: Participants with HIV-1 RNA < 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/ml or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
Measure: Proportion of participants with plasma Human Immunodeficiency Virus - Type I ribonucleic acid (HIV-1 RNA) levels less than (<) 50 copies/mL at week 12 Time: 12 weeks post enrollmentDescription: Participants with HIV-1 RNA < 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/ml or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at week 12 Time: 12 weeks post enrollmentDescription: Participants with HIV-1 RNA < 50 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/ml or with no HIV-1 RNA measurement within the week window are classified as failures.
Measure: Proportion of participants with HIV-1 RNA < 50 copies/mL at weeks 24, 36 and 48 Time: 24, 36 and 48 weeks post enrollmentDescription: Participants with HIV-1 RNA < 200 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/ml or with no HIV-1 RNA measurement within the week window are classified as failures.
Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at weeks 24, 36 and 48 Time: 24, 36 and 48 weeks post enrollmentDescription: Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are < 200 copies/ml and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is < 200 copies/ml. Otherwise the participant is classified as a failure.
Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at 12 weeks and maintained through 48 weeks Time: 24, 36 and 48 weeks post enrollmentDescription: For each participant, the percentage of days in each 7-day period in which all doses were taken is calculated, and then averaged across the 12 week interval (or number of weeks with available data).
Measure: Percent of days with all doses taken per week from weeks 0-12, 12-24, 24-36 and 36-48 Time: Enrollment through 48 weeksDescription: For each participant, the percentage of days in each 7-day period in which all doses were taken within the defined acceptable windows (within 4 hours for once/day ART and within 2 hours for twice/day ART) is calculated, and then averaged across the 12 week interval (or number of weeks with available data).
Measure: Percent of days with all doses taken within defined acceptable windows (within 4 hours for once/day ART and within 2 hours for twice/day ART) per week from weeks 0-12, 12-24, 24-36 and 36-48 Time: Enrollment through 48 weeksDescription: For each participant, the incidence rate during each 12 week interval is calculated as the ratio of the number of gaps between doses of >7 consecutive days relative to the number of days with data reported, times 100. Consecutive gaps of more than 7 days increase the gap count by one, e.g. missing 20 days counts as 2 gaps.
Measure: Incidence rate (per 100 days) of gaps between dosing of at least 7 consecutive days between weeks 0-12, 12-24, 24-36 and 36-48 Time: Enrollment through 48 weeksCurrently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV who have not achieved viral suppression through antiretroviral treatment may have a compromised immune system that leaves them vulnerable to infections and disease progression. However, little is known about the presentation and clinical outcomes of patients with HIV and SARS-CoV-2. Our aim is to characterize the clinical presentation and disease course of COVID-19 in patients with HIV.
Description: COVID-19 related death among patients with HIV and COVID-19
Measure: Mortality Time: 30 daysDescription: Percentage of patients who required hospitalization
Measure: Frequency of patients requiring hospital admissions Time: 30 daysDescription: Percentage of patients who required ICU admission
Measure: Frequency of patients requiring ICU admissions Time: 30 daysDescription: Percentage of patients who required respiratory support (new oxygen use, non-invasive ventilation,or invasive ventilation)
Measure: Frequency of respiratory support use Time: 30 daysDescription: Percentage of patients who developed acute kidney injury defined as increase in baseline creatinine, or use of renal replacement therapy
Measure: Frequency of kidney injury Time: 30 daysDescription: Percentage of patients who developed liver injury defined as increase in baseline ALT
Measure: Frequency of liver injury Time: 30 daysCOHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.
Description: To characterise the clinical features of symptomatic COVID-19 in PLWH (cardio-respiratory and other clinical signs or symptoms), described overall and by HIV and comorbid disease factors including pregnancy status.
Measure: Clinical features of symptomatic COVID-19 in people living with HIV (PLWH) Time: At baselineDescription: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.
Measure: Clinical outcomes of symptomatic COVID-19 in PLWH Time: At Day 28Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.
Measure: Clinical outcomes of symptomatic COVID-19 in PLWH Time: At Month 3Description: To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.
Measure: Seroprevalence of COVID-19 in all parent study participants Time: Through study completion, an average of one yearThis is an open-label, single sequence study that is being conducted to investigate the potential drug-drug interaction (DDI) when GSK3640254 is co-administered with a cocktail of cytochrome P450 (CYP) enzymes and transporter probe substrates in healthy participants. This study will aid in understanding these interactions and resulting changes in exposure (if any) when drugs that are metabolized via these pathways are given in combination with GSK3640254. The study will consist of a Screening period and 3 sequential treatment regimens. Participants will be administered a single dose of probe substrate drugs (caffeine 200 milligram (mg), metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg, midazolam 5 mg, digoxin 0.25 mg and pravastatin 40 mg) on Day 1, followed by washout of 10 days. Participants will then receive GSK3640254 200 mg once daily on Days 11 to 20 followed by co-administration of probe substrate drugs with GSK3640254 on Day 21. The total duration of the study will be approximately 54 days including Screening. Approximately 20 participants will be treated in the study.
Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of caffeine.
Measure: Area under the plasma concentration-time curve (AUC) from time zero to time t (AUC[0-t]) for caffeine Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of caffeine.
Measure: AUC from time zero extrapolated to infinity (AUC[0-inf]) for caffeine Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of caffeine.
Measure: Maximum observed concentration (Cmax) for caffeine Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of caffeine.
Measure: Time of maximum observed concentration (Tmax) for caffeine Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of caffeine.
Measure: Apparent terminal phase half-life (t1/2) for caffeine Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of metoprolol.
Measure: AUC(0-t) for metoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of metoprolol.
Measure: AUC(0-inf) for metoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of metoprolol.
Measure: Cmax for metoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of metoprolol.
Measure: Tmax for metoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of metoprolol.
Measure: t1/2 for metoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of montelukast.
Measure: AUC(0-t) for montelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of montelukast.
Measure: AUC(0-inf) for montelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of montelukast.
Measure: Cmax for montelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of montelukast.
Measure: Tmax for montelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of montelukast.
Measure: t1/2 for montelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of flurbiprofen.
Measure: AUC(0-t) for flurbiprofen Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of flurbiprofen.
Measure: AUC(0-inf) for flurbiprofen Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of flurbiprofen.
Measure: Cmax for flurbiprofen Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of flurbiprofen.
Measure: Tmax for flurbiprofen Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of flurbiprofen.
Measure: t1/2 for flurbiprofen Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of omeprazole.
Measure: AUC(0-t) for omeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of omeprazole.
Measure: AUC(0-inf) for omeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of omeprazole.
Measure: Cmax for omeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of omeprazole.
Measure: Tmax for omeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of omeprazole.
Measure: t1/2 for omeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of midazolam.
Measure: AUC(0-t) for midazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of midazolam.
Measure: AUC(0-inf) for midazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of midazolam.
Measure: Cmax for midazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of midazolam.
Measure: Tmax for midazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of midazolam.
Measure: t1/2 for midazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of digoxin.
Measure: AUC(0-t) for digoxin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of digoxin.
Measure: AUC(0-inf) for digoxin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of digoxin.
Measure: Cmax for digoxin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of digoxin.
Measure: Tmax for digoxin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of digoxin.
Measure: t1/2 for digoxin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin.
Measure: AUC(0-t) for pravastatin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin.
Measure: AUC(0-inf) for pravastatin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin.
Measure: Cmax for pravastatin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin.
Measure: Tmax for pravastatin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin.
Measure: t1/2 for pravastatin Time: Day 1 to Day 26Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measure: Number of participants with adverse events (AEs) Time: Day 1 to Day 26Description: SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement.
Measure: Number of participants with serious adverse events (SAEs) Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Absolute values of platelets, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils (Giga cells per Liter) Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Absolute values of absolute neutrophil count Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Absolute values of hematocrit Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Absolute values of hemoglobin (Hgb) Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Absolute values of Red blood cell (RBC) count Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Absolute values of Mean corpuscular volume (MCV) Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Absolute values of Mean corpuscular hemoglobin (MCH) Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Absolute values of blood urea nitrogen (BUN), sodium, glucose (fasting), potassium, phosphorus, calcium, chloride and carbon dioxide (Millimoles per Liter) Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Absolute values of anion gap Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Absolute values of total cholesterol Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Absolute values of triglycerides Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Absolute values of creatinine, direct bilirubin, total bilirubin, and uric acid (Micromoles per Liter) Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Absolute values of albumin, globulin and total protein (Grams per Liter) Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), lipase, amylase, lactate dehydrogenase (LDH) and creatinine phosphokinase (International Units per Liter) Time: Day 1 to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Absolute values of urine specific gravity Time: Day 1 to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Absolute values of urine potential of hydrogen (pH) Time: Day 1 to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Absolute values of urine glucose Time: Day 1 to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Absolute values of urine protein Time: Day 1 to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Absolute values of urine blood Time: Day 1 to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Absolute values of urine ketones Time: Day 1 to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Absolute values of urine bilirubin and nitrite (Milligrams per deciliter) Time: Day 1 to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Absolute values of urine leukocyte esterase by dipstick Time: Day 1 to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Change from Baseline in platelets, WBC count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils (Giga cells per Liter) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Change from Baseline in absolute neutrophil count (10^9 per Liter) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Change from Baseline in hematocrit Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Change from Baseline in Hgb Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Change from Baseline in RBC count Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Change from Baseline in MCV Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Change from Baseline in MCH Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Change from Baseline in BUN, sodium, glucose (fasting), potassium, phosphorus, calcium, chloride and carbon dioxide (Millimoles per Liter) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Change from Baseline in anion gap Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Change from Baseline in total cholesterol Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Change from Baseline in triglycerides Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Change from Baseline in creatinine, direct bilirubin, total bilirubin, and uric acid (Micromoles per Liter) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Change from Baseline in albumin, globulin and total protein (Grams per Liter) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Change from Baseline in ALT, AST, ALP, GGT, creatinine phosphokinase, lipase, amylase, and LDH (International Units per Liter) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Change from Baseline in urine specific gravity Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Change from Baseline in urine pH Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Change from Baseline in urine glucose Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Change from Baseline in urine protein Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Change from Baseline in urine blood Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Change from Baseline in urine ketones Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Change from Baseline in urine bilirubin and nitrite (Milligrams per deciliter) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Urine samples will be collected for the assessment of urine parameters.
Measure: Change from Baseline in urine leukocyte esterase by dipstick Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 10 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured.
Measure: Absolute values of electrocardiogram (ECG) parameters: PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds) Time: Day 1 to Day 26Description: Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 10 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured.
Measure: Change from Baseline in ECG parameters: PR, QRS, QT, and QTcF (Milliseconds) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Temperature will be assessed using an automated device.
Measure: Absolute values of oral temperature Time: Day 1 to Day 26Description: Temperature will be assessed using an automated device.
Measure: Change from Baseline in oral temperature Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Pulse rate will be assessed in the supine position with a completely automated device.
Measure: Absolute values of pulse rate Time: Day 1 to Day 26Description: Pulse rate will be assessed in the supine position with a completely automated device.
Measure: Change from Baseline in pulse rate Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Respiratory rate will be assessed in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Measure: Absolute values of respiratory rate Time: Day 1 to Day 26Description: Respiratory rate will be assessed in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Measure: Change from Baseline in respiratory rate Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood pressure will be assessed in the supine position with a completely automated device.
Measure: Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury) Time: Day 1 to Day 26Description: Blood pressure will be assessed in the supine position with a completely automated device.
Measure: Change from Baseline in SBP and DBP (Millimeters of mercury) Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Oxygen saturation of participants will be assessed using pulse oximetry.
Measure: Absolute values of oxygen saturation Time: Day 1 to Day 26Description: Oxygen saturation of participants will be assessed using pulse oximetry.
Measure: Change from Baseline in oxygen saturation Time: Baseline (Day -1, Pre-dose) and up to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254
Measure: AUC(0-t) for GSK3640254 Time: Day 11 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254
Measure: AUC from time zero to the end of the dosing interval at steady state (AUC[0-tau]) for GSK3640254 Time: Day 11 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254
Measure: Cmax for GSK3640254 Time: Day 11 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254
Measure: Plasma concentration at the end of the dosing interval (Ctau) for GSK3640254 Time: Day 11 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254
Measure: Tmax for GSK3640254 Time: Day 11 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254
Measure: t1/2 for GSK3640254 Time: Day 11 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol.
Measure: AUC(0-t) for alpha-hydroxymetoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol.
Measure: AUC(0-inf) for alpha-hydroxymetoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol.
Measure: Cmax for alpha-hydroxymetoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol.
Measure: Tmax for alpha-hydroxymetoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol.
Measure: t1/2 for alpha-hydroxymetoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast.
Measure: AUC(0-t) for 36-hydroxymontelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast.
Measure: AUC(0-inf) for 36-hydroxymontelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast.
Measure: Cmax for 36-hydroxymontelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast.
Measure: Tmax for 36-hydroxymontelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast.
Measure: t1/2 for 36-hydroxymontelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole.
Measure: AUC(0-t) for 5-hydroxyomeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole.
Measure: AUC(0-inf) for 5-hydroxyomeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole.
Measure: Cmax for 5-hydroxyomeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole.
Measure: Tmax for 5-hydroxyomeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole.
Measure: t1/2 for 5-hydroxyomeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam.
Measure: AUC(0-t) for 1-hydroxymidazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam.
Measure: AUC(0-inf) for 1-hydroxymidazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam.
Measure: Cmax for 1-hydroxymidazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis 1-hydroxymidazolam.
Measure: Tmax for 1-hydroxymidazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam.
Measure: t1/2 for 1-hydroxymidazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin lactone.
Measure: AUC(0-t) for pravastatin lactone Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin lactone.
Measure: AUC(0-inf) for pravastatin lactone Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin lactone.
Measure: Cmax for pravastatin lactone Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin lactone.
Measure: Tmax for pravastatin lactone Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of pravastatin lactone.
Measure: t1/2 for pravastatin lactone Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of Cmax of alpha-hydroxymetoprolol to metoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of AUC(0-inf) of alpha-hydroxymetoprolol to metoprolol Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of Cmax of 36-hydroxymontelukast to montelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of AUC(0-inf) of 36-hydroxymontelukast to montelukast Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of Cmax of 5-hydroxyomeprazole to omeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of AUC(0-inf) of 5-hydroxyomeprazole to omeprazole Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of Cmax of 1-hydroxymidazolam to midazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of AUC(0-inf) of 1-hydroxymidazolam to midazolam Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of Cmax of pravastatin lactone to pravastatin Time: Day 1 to Day 26Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measure: Ratio of AUC(0-inf) of pravastatin lactone to pravastatin Time: Day 1 to Day 26"SKILLZ," is a mixed methods evaluation of the Grassroots Soccer (GRS) SKILLZ Package based in Lusaka, Zambia. The package is made up of three football-based programs: (1) SKILLZ-Girl - implemented in schools as part of a 10-week program culminating in a tournament event; (2) SKILLZ-Club - implemented as an ongoing extra-curricular activity after the completion of SKILLZ-Girl; (3) SKILLZ-Plus - a clinic based football group targeted at girls that are HIV-positive. The programs work together to build a continued support system which encourages uptake of Sexual Reproductive Health (SRH) and HIV services, while facilitating ART adherence (for HV-positive participants) and continued engagement with health services over the long-term (whether to contraceptive methods, HIV prevention services, HIV repeat testing, and/or HIV treatment and care). The study team has developed an enhanced SKILLZ-Girl offering, which will include a comprehensive module on HIVST, contraceptives and PrEP, access to a nurse during the implementation of sessions and the additional offering of HIVST and contraceptive services at the event along with ongoing engagement through the SKILLZ-Club program (Enhanced Arm) , The central hypothesis is that this enhanced curriculum will increase HIV testing and contraceptive uptake compared to the standard SKILLZ curriculum & standard event (SOC Arm). The investigators further hypothesize that the intervention in the enhanced arm will positively and directly affect a number of mediating factors including attendance at soccer events where community-based SRH services are offered, SRH knowledge, empowerment, self-confidence, and perceptions of gender balance, and (reduced) stigma. For girls found to be HIV-positive, the follow-on SKILLZ intervention (SKILLZ-Plus) has been designed to facilitate linkage to HIV care and treatment, reduce HIV-related stigma, increase disclosure to family and partners, increase feelings of social support, empowerment, self-efficacy, and ultimately adherence to ARVs, viral load suppression (VLS) and retention in HIV care and treatment. This study will be conducted in up to 32 secondary schools that GRS currently serves in the Lusaka Urban District.
Description: Number of participants, enrolled in the study, undergoing HIV testing (HIVST our Determine tests) over 2 years. Collected from facility testing registers and community testing registers.
Measure: Number of participants undergoing HIV testing within 24 months Time: 24 monthsDescription: Number of participants, enrolled in the study, accessing contraception, PreP or PEP over 2 years. Determined through the electronic medical record and clinic registers.
Measure: Number of participants accessing SRH related prevention services within 24 months Time: 24 monthsDescription: The percentage of participants, testing HIV positive, who have an undetectable viral load (as defined by the laboratory doing the test) after one year on treatment. Collected from routine laboratory data.
Measure: The percentage of HIV infected participants being virally suppressed at 12 months Time: 12 monthsDescription: The percentage of participants, testing HIV positive, who are actively retained in care at 3 months ie are not more than 7 days late for a scheduled appointment. Determined using the electronic medical record.
Measure: The percentage of HIV infected participants retained in care at 3 months Time: 3 monthsDescription: The percentage of participants, testing HIV positive, that have made their scheduled visit to the clinic within the first at 6 months of enrolment. (less than 7 days late), using the electronic medical record.
Measure: The percentage of HIV infected participants retained in care at 6 months Time: 6 monthsDescription: The percentage of participants, testing HIV positive, who attend their scheduled visits within the first 12 months of enrolment (less than seven days late). determined through the electronic medical record.
Measure: The percentage of HIV infected participants retained in care at 12 months Time: 12 monthsDescription: FGD's, IDI's and routine program data ( attendance registers, process data and documented observations) will be used to identify mediators, predictors, and barriers to uptake of the SKILLZ package after implementation
Measure: Conduct a process evaluation to describe how the intervention worked Time: 24 monthsDescription: Costs will include the personnel to manage the intervention, financial incentives and other related miscellaneous costs. These will be collected by the program manager and study team and will be based on actual costs.
Measure: Average short-term costs for the program implementation based on net-costs for the intervention. Time: Baseline through 12 monthsDescription: Each session that is conducted will be documented including number of participants in attendance (assessed voia attendance registers and routine program data).
Measure: Fidelity monitoring or adherence to the program as measured by the number of coaching sessions conducted per plan. Time: Baseline through 12 monthsDescription: Record and track key barriers through review of routine program data that prevent participants from engaging with the intervention. ie through review of the data collected by coaches from feedback from participants, FGD's and IDI's. During this COVID-19 period, we may be limited or may need to revise our anticipated collection of study results. The study record will reflect these changes as we navigate through the course of the study.
Measure: Identify barriers that prevent intervention participation Time: Baseline through 12 months