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Report for D015658: HIV Infections NIH

(Synonyms: HIV In, HIV Inf, HIV Infe, HIV Infec, HIV Infect, HIV Infecti, HIV Infectio, HIV Infection, HIV Infections)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug397 DRV Wiki 1.00
drug157 BR Wiki 1.00
drug7 100 mg/mL Virazole Wiki 1.00
drug42 ATV Wiki 1.00
drug28 50 mg/mL Virazole Wiki 1.00
drug333 Cobicistat Wiki 1.00

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D000163 Acquired Immunodeficiency Syndrome NIH 1.00
D007153 Immunologic Deficiency Syndromes NIH 0.58

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002721 Immunodeficiency HPO 0.58

There is one clinical trial.

Clinical Trials


1 A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants

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)

NCT02016924 Acquired Immune Deficiency Syndrome (AIDS) HIV Infections Drug: ATV Drug: DRV Drug: Cobicistat Drug: BR
MeSH:HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Primary Outcomes

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 10

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, 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 4

Measure: Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Treatment Emergent Laboratory Abnormalities Through Week 24

Time: First dose date and up to 24 weeks plus 30 days

Secondary Outcomes

Description: 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 48

Description: 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 48

Description: 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 48

Description: 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 48

Measure: The incidence of treatment-emergent AEs and treatment-emergent laboratory abnormalities through Week 48

Time: Up to 48 weeks plus 30 days

Measure: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 and as defined by the US FDA-defined snapshot algorithm

Time: Week 24

Measure: The change from baseline in CD4+ cell counts

Time: Week 24

Measure: The change from baseline in CD4+ cell counts

Time: Week 48

Measure: The change from baseline in CD4+ percentages

Time: Week 24

Measure: The change from baseline in CD4+ percentages

Time: Week 48

Measure: Acceptability of COBI and F/TAF as Measured by Palatability

Time: Day 1, and at Weeks 4 (Day 10 for Cohort 1 Part A), 24 and 48.


HPO Nodes