Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATV · 1 trial · 2 indications
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). AUCtau for ATV (Cohorts 1 Part A, 2, 3, and 4 \[Groups 2 to 4\]); DRV (Cohorts 1 Part A, 2, and 3); TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 \[Groups 1 to 3\] taking F/TAF); and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 \[Groups 1 to 3\] taking F/TAF) will be reported.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Part A and Part B | EXPERIMENTAL | Participants ages 12 to \<18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents. |
| Cohort 2 | EXPERIMENTAL | Participants aged 6 to \<12 years old and ≥25 to \<40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV. |
| Cohort 3 | EXPERIMENTAL | Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV. |
| Cohort 4 (Group 1) | EXPERIMENTAL | Participants age ≥ 4 weeks old weighing 14 to \< 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 2) | EXPERIMENTAL | Participants age ≥ 4 weeks old weighing 10 to \< 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 3) | EXPERIMENTAL | Participants age ≥ 4 weeks old weighing 6 to \< 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 4) | EXPERIMENTAL | Participants age ≥ 4 weeks old weighing 3 to \< 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 5 (Group 1) | EXPERIMENTAL | Participants ages ≥ 4 weeks old weighing ≥ 10 to \< 14 kg will receive F/TAF TOS 60/7.5 mg, once daily with the third unboosted drug. |
| Cohort 5 (Group 2) | EXPERIMENTAL | Participants ages ≥ 4 weeks old weighing ≥ 6 to \< 10 kg will receive F/TAF TOS 30/3.75 mg, once daily with the third unboosted drug. |
| Cohort 5 (Group 3) | EXPERIMENTAL | Participants ages ≥ 4 weeks old weighing ≥ 3 to \< 6 kg will receive F/TAF TOS 15/1.88 mg, once daily with the third unboosted drug. |
| Name | Type | Description |
|---|---|---|
| ATV | DRUG | Capsules administered once daily according to dosing recommendations per product monograph |
| DRV | DRUG | Tablets administered once daily according to dosing recommendations per product monograph |
| Cobicistat | DRUG | Tablets administered orally once daily with food |
| BR | DRUG | Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), and emtricitabine (FTC). |
| F/TAF | DRUG | Tablets administered orally once daily |
| LPV/r | DRUG | Solution administered orally |
| Third Unboosted Drug | DRUG | ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites. |
| Cobicistat TOS | DRUG | Tablets for oral suspension |
| F/TAF TOS | DRUG | Tablets for oral suspension |
Key Inclusion Criteria: * HIV-1 infected, virologically suppressed males and females age ≥ 4 weeks to \< 18 years (according to requirements of enrolling Cohort). * Body weight at screening ≥ 25 to \< 40 kg (Cohort 2); ≥ 14 to \< 25 kg (Cohort 3); ≥ 3 to \< 25 kg (Cohort 4); ≥ 3 to \< 14 kg (Cohort...
ATV is an investigational small molecule being studied for the treatment of Acquired Immune Deficiency Syndrome (AIDS) and HIV infections. It is currently in Phase 2 clinical development, and it is not yet approved by regulatory authorities.
ATV is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting a Phase 2 clinical trial to evaluate the drug in pediatric patients with HIV.
ATV is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The drug is being studied in an active but not recruiting clinical trial for the treatment of AIDS and HIV infections.
ATV is being studied in one Phase 2 clinical trial with the identifier NCT02016924. This trial is titled "Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV" and is enrolling 133 participants.
ATV is an abbreviation for Atazanavir, an antiretroviral medication. In the context of the clinical trial NCT02016924, ATV refers to Atazanavir boosted with cobicistat, which is being studied in combination with other antiretroviral agents for the treatment of HIV in children.