Open
Actively Recruiting
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
About
Brief Summary
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to < 18 years) with HIV.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 5)
- Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening
visit.
- Participants enrolled prior to implementation of Amendment 7: 2 NRTIs and ATV/r once daily or DRV/r once daily or twice daily.
- Participants enrolled after the implementation of Amendment 9:
- Cohorts 2, 3 and 4 (Group 1): 2 NRTIs plus a third agent per local
prescribing guidelines. Participants will switch from their current third
agent to ATV or DRV at Day 1. Participants taking DRV must be on once-daily
dosing or must switch to once daily at or prior to Day 1. Cohort 4 (Group
1), participants may also switch their current third agent to LPV/r at Day
- Participants will switch their NRTI backbone to F/TAF.
- Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): 2 NRTIs plus a third agent per local prescribing guidelines or treatment naive. Participants on treatment will switch from their current third agent to ATV or LPV/r (Cohort 4 [Groups 2 to 4]), or to a third unboosted agent (Cohort 5 [Groups 1 to 3]). Participants will switch their NRTI backbone to F/TAF.
- Cohorts 2, 3 and 4 (Group 1): 2 NRTIs plus a third agent per local
prescribing guidelines. Participants will switch from their current third
agent to ATV or DRV at Day 1. Participants taking DRV must be on once-daily
dosing or must switch to once daily at or prior to Day 1. Cohort 4 (Group
1), participants may also switch their current third agent to LPV/r at Day
- Participants undergoing dose modifications to their ARV regimen for growth or switching medication formulations are considered to be on a stable ARV regimen.
- Documented plasma HIV-1 RNA for ≥ 3 months preceding the screening visit:
- Participants enrolled after the implementation of Amendment 9:
- For Cohorts 2, 3, and 4 (Group 1), virologically suppressed ≥ 3 months preceding the screening visit: HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
- For Cohorts 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3), on an ARV regimen irrespective of plasma HIV-1 RNA copies or treatment naive; a participant is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment
- For virologically suppressed participants, unconfirmed virologic elevations of HIV-1 RNA ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on 2 consecutive HIV-1 RNA tests.
- Participants enrolled after the implementation of Amendment 9:
- Adequate renal function: Estimated Glomerular Filtration Rate (eGFR) ≥ 90
mL/min/1.73m2 using the Schwartz formula. If ≥ 1 year old, eGFR greater than or equal
to the minimum normal value for age using the Schwartz Formula. If < 1 year old as
follows:
- Age Minimum Value for eGFR (mL/min/1.73 m2) > 28 days to ≤ 95 days 30, ≥ 96 days to ≤ 6 months 39, > 6 to < 12 months 49
- Participants must not have documented or suspected resistance to applicable study drugs including FTC, TFV, ATV, DRV, or LPV. Participants < 14 kg (Cohorts 4 [Groups 2 to 4] and 5 [Groups 1 to 3]) with M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed.
- Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age).
- Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): Last dose of nevirapine or efavirenz, if applicable, ≥ 14 days prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria do apply.
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Study Stats
Protocol No.
19-001980
Category
Infectious Diseases
Principal Investigator
Contact
Location
- UCLA Westwood