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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug823 | Cabotegravir Tablets Wiki | 1.00 |
| drug824 | Cabotegravir extended release suspension for injection (long-acting) Wiki | 0.71 |
| drug3370 | Rilpivirine extended release suspension for injection (long-acting) Wiki | 0.71 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 2 clinical trials
This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram (mg) and a 900 mg intramuscular (IM) injection respectively, to separate vastus lateralis muscles on each leg. Cabotegravir is an integrase inhibitor being developed in combination with rilpivirine, a non-nucleoside reverse transcriptase inhibitor, for the treatment of human immunodeficiency virus (HIV). The objective is to evaluate pharmacokinetics, tolerability, and safety of cabotegravir long acting plus rilpivirine long acting administered concomitantly as two separate IM injections in the vastus lateralis muscle of adult healthy participants. The screening phase will be of 30 days, oral lead-in (OLI) phase of 28 days, there will be washout period of 10-14 days, followed by an injection phase and follow-up period will be up to 52-weeks. Approximately 15 adult healthy participants will be enrolled.
Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.
Measure: Maximum observed concentration (Cmax) for cabotegravir (injection phase) Time: Day 1 (Pre-dose, 1 hour, 2 hours) and one post-dose sample on Day 2, Day 4, Day 5, Day 7, Day 10, Day 15, Day 17, Day 22 and Day 28Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.
Measure: Time of Cmax (Tmax) for cabotegravir (injection phase) Time: Day 1 (Pre-dose, 1 hour, 2 hours) and one post-dose sample on Day 2, Day 4, Day 5, Day 7, Day 10, Day 15, Day 17, Day 22 and Day 28Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.
Measure: Area under the plasma concentration-time curve from time zero to time (AUC[0-t]) for cabotegravir (injection+follow-up phase) Time: Day 1 (Pre-dose, 1 hour, 2 hours) and one post-dose sample on Day 2, Day 4, Day 5, Day 7, Day 10, Day 15, Day 17, Day 22, Day 28, Week 8, Week 12, Week 24, Week 36 and Week 52Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.
Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-infinity]) for cabotegravir (injection+follow-up phase) Time: Day 1 (Pre-dose, 1 hour, 2 hours) and one post-dose sample on Day 2, Day 4, Day 5, Day 7, Day 10, Day 15, Day 17, Day 22, Day 28, Week 8, Week 12, Week 24, Week 36 and Week 52Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.
Measure: Apparent terminal phase half-life (t1/2) for cabotegravir (follow-up phase) Time: One post-dose sample at Week 8, Week 12, Week 24, Week 36, and Week 52Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.
Measure: Absorption rate constant for cabotegravir (follow-up phase) Time: One post-dose sample at Week 8, Week 12, Week 24, Week 36, and Week 52Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of rilpivirine.
Measure: Cmax for rilpivirine (injection phase) Time: Day 1 (Pre-dose, 1 hour, 2 hours) and one post-dose sample on Day 2, Day 4, Day 5, Day 7, Day 10, Day 15, Day 17, Day 22 and Day 28Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of rilpivirine.
Measure: Tmax for rilpivirine (injection phase) Time: Day 1 (Pre-dose, 1 hour, 2 hours) and one post-dose sample on Day 2, Day 4, Day 5, Day 7, Day 10, Day 15, Day 17, Day 22 and Day 28Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of rilpivirine.
Measure: AUC(0-t) for rilpivirine (injection+follow-up phase) Time: Day 1 (Pre-dose, 1 hour, 2 hours) and one post-dose sample on Day 2, Day 4, Day 5, Day 7, Day 10, Day 15, Day 17, Day 22, Day 28, Week 8, Week 12, Week 24, Week 36 and Week 52Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of rilpivirine.
Measure: AUC(0-infinity) for rilpivirine (injection+follow-up phase) Time: Day 1 (Pre-dose, 1 hour, 2 hours) and one post-dose sample on Day 2, Day 4, Day 5, Day 7, Day 10, Day 15, Day 17, Day 22, Day 28, Week 8, Week 12, Week 24, Week 36 and Week 52Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of rilpivirine.
Measure: t1/2 for rilpivirine (follow-up phase) Time: One post-dose sample at Week 8, Week 12, Week 24, Week 36, and Week 52Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of rilpivirine.
Measure: Absorption rate constant for rilpivirine (follow-up phase) Time: One post-dose sample at Week 8, Week 12, Week 24, Week 36, and Week 52Human immunodeficiency virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) is a worldwide epidemic that continues to grow significantly causing new infections and related deaths per year. Chronic HIV infection in adults continues to be characterized by increased development and transmission of resistant virus and issues associated with long-term toxicity of antiretroviral therapy (ART). The current paradigm in the treatment of HIV involves life-long therapy with multiple antiretrovirals (ARVs). This dependency on medical therapy requires a need for continuous improvement on the durability, tolerability and convenience of all antiretroviral classes. This is a Phase IIIb, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study (SOLAR: Switch Onto Long Acting Regimen). It is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA administered every 2 months (Q2M) compared with maintenance of BIK. Approximately 654 adult HIV-1 infected participants who are on the stable ARV regimen BIK will be randomized in a 2:1 ratio to either be switched to the CAB LA + RPV LA regimen or continue BIK through 12 months. The study will continue with an Extension Phase after Month 12 Oral Lead-In (OLI) and BIK/Month 11 Direct to Injection (D2I). BIKTARVY is a registered trademark of Gilead Sciences.
Description: Participants with plasma HIV-1 RNA >=50 c/mL per Food and Drug Administration (FDA) snapshot algorithm will be assessed.
Measure: Percentage of participants with plasma human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) greater than or equal to (>=) 50 copies per mL (c/mL) - OLI Time: At Month 12Description: Participants with plasma HIV-1 RNA >=50 c/mL per FDA snapshot algorithm will be assessed.
Measure: Percentage of participants with plasma HIV-1 RNA >=50 c/mL - D2I Time: At Month 11Description: Participants with plasma HIV-1 RNA >=50 c/mL per FDA snapshot algorithm will be assessed.
Measure: Percentage of participants with plasma HIV-1 RNA >=50 c/mL - BIK Time: At Month 12Description: Participants with plasma HIV-1 RNA <50 c/mL per FDA snapshot algorithm will be assessed.
Measure: Percentage of participants with plasma HIV-1 RNA less than (<)50 c/mL - OLI Time: At Months 6 and 12Description: Participants with plasma HIV-1 RNA <50 c/mL per FDA snapshot algorithm will be assessed.
Measure: Percentage of participants with plasma HIV-1 RNA <50 c/mL - D2I Time: At Months 5 and 11Description: Participants with plasma HIV-1 RNA <50 c/mL per FDA snapshot algorithm will be assessed.
Measure: Percentage of participants with plasma HIV-1 RNA <50 c/mL - BIK Time: At Months 6 and 12Description: CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL.
Measure: Percentage of participants with protocol-defined confirmed virologic failure (CVF) - OLI Time: Up to Month 12Description: CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL.
Measure: Percentage of participants with protocol-defined CVF - D2I Time: Up to Month 11Description: CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL.
Measure: Percentage of participants with protocol-defined CVF - BIK Time: Up to Month 12Description: Participants with plasma HIV-1 RNA >=50 c/mL will be assessed per FDA snapshot algorithm.
Measure: Percentage of participants with HIV-RNA >= 50 c/mL - OLI Time: At Month 6Description: Participants with plasma HIV-1 RNA >=50 c/mL will be assessed per FDA snapshot algorithm.
Measure: Percentage of participants with HIV-RNA >= 50 c/mL - D2I Time: At Month 5Description: Participants with plasma HIV-1 RNA >=50 c/mL will be assessed per FDA snapshot algorithm.
Measure: Percentage of participants with HIV-RNA >= 50 c/mL - BIK Time: At Month 6Description: Absolute values of HIV viral load will be assessed.
Measure: Absolute values of HIV viral load - OLI Time: At Months 6 and 12Description: Absolute values of HIV viral load will be assessed.
Measure: Absolute values of HIV viral load - D2I Time: At Months 5 and 11Description: Absolute values of HIV viral load will be assessed.
Measure: Absolute values of HIV viral load - BIK Time: At Months 6 and 12Description: Change from Baseline in HIV viral load will be assessed.
Measure: Change from Baseline in HIV viral load (c/mL) - OLI Time: Baseline (Day 1) and at Months 6 and 12Description: Change from Baseline in HIV viral load will be assessed.
Measure: Change from Baseline in HIV viral load (c/mL) - D2I Time: Baseline (Day 1) and at Months 5 and 11Description: Change from Baseline in HIV viral load will be assessed.
Measure: Change from Baseline in HIV viral load (c/mL) - BIK Time: Baseline (Day 1) and at Months 6 and 12Description: Absolute values of CD4+ cell counts will be assessed.
Measure: Absolute values of cluster of differentiation 4 plus (CD4+) cell counts - OLI Time: At Months 6 and 12Description: Absolute values of CD4+ cell counts will be assessed.
Measure: Absolute values of CD4+ cell counts - D2I Time: At Months 5 and 11Description: Absolute values of CD4+ cell counts will be assessed.
Measure: Absolute values of CD4+ cell counts - BIK Time: At Months 6 and 12Description: Change from Baseline in CD4+ cell will be assessed.
Measure: Change from Baseline in CD4+ cell counts (Cells per cubic millimeters [cells/mm^3]) - OLI Time: Baseline (Day 1) and at Months 6 and 12Description: Change from Baseline in CD4+ cell will be assessed.
Measure: Change from Baseline in CD4+ cell counts (cells/mm^3) - D2I Time: Baseline (Day 1) and at Months 5 and 11Description: Change from Baseline in CD4+ cell will be assessed.
Measure: Change from Baseline in CD4+ cell counts (cells/mm^3) - BIK Time: Baseline (Day 1) and at Months 6 and 12Description: Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent phenotypic resistance to CAB, RPV, BIC, FTC, and TAF.
Measure: Number of participants with treatment-emergent phenotypic resistance - OLI Time: Up to Month 12Description: Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent phenotypic resistance to CAB, RPV, BIC, FTC, and TAF.
Measure: Number of participants with treatment-emergent phenotypic resistance - D2I Time: Up to Month 11Description: Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent phenotypic resistance to CAB, RPV, BIC, FTC, and TAF.
Measure: Number of participants with treatment-emergent phenotypic resistance - BIK Time: Up to Month 12Description: Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent genotypic resistance to CAB, RPV, BIC, FTC, and TAF.
Measure: Number of participants with treatment-emergent genotypic resistance - OLI Time: Up to Month 12Description: Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent genotypic resistance to CAB, RPV, BIC, FTC, and TAF.
Measure: Number of participants with treatment-emergent genotypic resistance - D2I Time: Up to Month 11Description: Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent genotypic resistance to CAB, RPV, BIC, FTC, and TAF.
Measure: Number of participants with treatment-emergent genotypic resistance - BIK Time: Up to Month 12Description: Blood and urine samples will be collected over time to assess renal and bone biomarkers.
Measure: Number of participants with abnormal renal and bone biomarkers - OLI Time: At Months 6 and 12Description: Blood and urine samples will be collected over time to assess renal and bone biomarkers.
Measure: Number of participants with abnormal renal and bone biomarkers - D2I Time: At Months 5 and 11Description: Blood and urine samples will be collected over time to assess renal and bone biomarkers.
Measure: Number of participants with abnormal renal and bone biomarkers - BIK Time: At Months 6 and 12Description: Metabolic syndrome is a cluster of conditions that occurs together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions include increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels.
Measure: Percentage of participants with Metabolic syndrome - OLI Time: At Months 6 and 12Description: Metabolic syndrome is a cluster of conditions that occurs together increasing one's risk of heart disease, stroke and type 2 DM. These conditions include increased BP, elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and TG levels.
Measure: Percentage of participants with Metabolic syndrome - D2I Time: At Months 5 and 11Description: Metabolic syndrome is a cluster of conditions that occurs together increasing one's risk of heart disease, stroke and type 2 DM. These conditions include increased BP, elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and TG levels.
Measure: Percentage of participants with Metabolic syndrome - BIK Time: At Months 6 and 12Description: Insulin resistance will be assessed using homeostasis model of assessment-insulin resistance (HOMA-IR) Score.
Measure: Number of participants with insulin resistance - OLI Time: At Months 6 and 12Description: Insulin resistance will be assessed using HOMA-IR Score.
Measure: Number of participants with insulin resistance - D2I Time: At Months 5 and 11Description: Insulin resistance will be assessed using HOMA-IR Score.
Measure: Number of participants with insulin resistance -BIK Time: At Months 6 and 12Description: The "Preference" questionnaire will include 3 questions and assess whether participants prefer the CAB LA + RPV LA injectable treatment or the daily oral ARV regimen, also evaluating the attributes supporting this preference.
Measure: Percentage of participants with their treatment Preference as Assessed Using Preference Questionnaire - OLI Time: At Month 12Description: The "Preference" questionnaire will include 3 questions and assess whether participants prefer the CAB LA + RPV LA injectable treatment or the daily oral ARV regimen, also evaluating the attributes supporting this preference.
Measure: Percentage of participants with their Treatment Preference as Assessed Using Preference Questionnaire - D2I Time: At Month 11Description: The "Preference" questionnaire will include 3 questions and assess whether participants prefer the CAB LA + RPV LA injectable treatment or the daily oral ARV regimen, also evaluating the attributes supporting this preference.
Measure: Percentage of Participants with their treatment Preference as Assessed Using Preference Questionnaire - BIK Time: At Month 12Description: The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks.
Measure: Change From Baseline in Total Treatment Satisfaction Score using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) (scores on a scale) - OLI Time: Baseline (Day 1) and at Months 6 and 12Description: The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks.
Measure: Change From Baseline in Total Treatment Satisfaction Score using HIVTSQs (scores on a scale) - D2I Time: Baseline (Day 1) and at Months 5 and 11Description: The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks.
Measure: Change From Baseline in Total Treatment Satisfaction Score using HIVTSQs (scores on a scale)- BIK Time: Baseline (Day 1) and at Months 6 and 12Description: HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment.
Measure: Change From Baseline in individual item scores using HIVTSQs (scores on a scale) - OLI Time: Baseline (Day 1) and at Months 6 and 12Description: HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment.
Measure: Change From Baseline in individual item scores using HIVTSQs (scores on a scale) - D2I Time: Baseline (Day 1) and at Months 5 and 11Description: HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment.
Measure: Change From Baseline in individual item scores using HIVTSQs (scores on a scale) - BIK Time: Baseline (Day 1) and at Months 6 and 12Description: The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 will represent no change.
Measure: Number of participants with change in treatment satisfaction over time using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)- OLI Time: At Month 12Description: The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 will represent no change.
Measure: Number of participants with change in treatment satisfaction over time using HIVTSQc - D2I Time: At Month 11Description: The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 will represent no change.
Measure: Number of participants with change in treatment satisfaction over time using HIVTSQc - BIK Time: At Month 12Description: The PIN questionnaire explores the bother of pain at the injection site and injection site reaction (ISRs), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is always equated with the most favorable perception of vaccination, and 5 is the most unfavorable.
Measure: Number of participants with change in Dimension Scores Using Perception of Injection (PIN) Questionnaire - OLI Time: At Months 2, 6, and 12Description: The PIN questionnaire explores the bother of pain at the injection site and injection site reaction (ISRs), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is always equated with the most favorable perception of vaccination, and 5 is the most unfavorable.
Measure: Number of participants with change in Dimension Scores Using PIN Questionnaire - D2I Time: At Months 1, 5, and 11Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports