A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
Phase 4
Recruiting
- Conditions
- HIV-1-infection
- Interventions
- Drug: F/TAF (High Dose Tablet)Drug: B/F/TAF (Low Dose)Drug: E/C/F/TAF (Low Dose)Drug: F/TAF (Low Dose Tablet)Drug: F/TAF (Lowest Dose Tablet)Drug: F/TAF (High Dose TOS)Drug: B/F/TAF (High Dose)Drug: F/TAF (Low Dose TOS)Drug: B/F/TAF (Lowest Dose TOS)Drug: F/TAF (Lowest Dose TOS)Drug: B/F/TAF (High Dose TOS)Drug: 3rd ARV AgentDrug: B/F/TAF (Low Dose TOS)Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI)Drug: ATVDrug: DRV
- Registration Number
- NCT06337032
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.
The primary objectives of this study are as follows:
* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.
* To evaluate the safety of the study drug(s) in participants with HIV-1.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
- Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, GS-US-216-0128, or CO-US-380-5578 and gave consent to study participation.
Key
Exclusion Criteria
-
Individuals planning to switch to B/F/TAF on Day 1 cannot have plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.
- Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
-
Individuals planning to switch to B/F/TAF must not have any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.
-
For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.
-
For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.
-
Ongoing treatment with or prior use of any prohibited medications.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF Cobicistat (TOS) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF) B/F/TAF (Low Dose) Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant. Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF) B/F/TAF (Lowest Dose TOS) Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant. Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF B/F/TAF (High Dose) Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight. Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF E/C/F/TAF Participants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF B/F/TAF (Low Dose) Participants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF F/TAF (High Dose TOS) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF E/C/F/TAF (Low Dose) Participants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF B/F/TAF (Lowest Dose TOS) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF F/TAF (High Dose Tablet) Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight. Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF F/TAF (Low Dose Tablet) Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight. Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF B/F/TAF (Low Dose) Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight. Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF B/F/TAF (High Dose TOS) Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF F/TAF (Lowest Dose Tablet) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF F/TAF (Low Dose TOS) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF F/TAF (Lowest Dose Tablet) Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight. Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF 3rd ARV Agent Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF F/TAF (Lowest Dose TOS) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF B/F/TAF (High Dose) Participants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF F/TAF (High Dose Tablet) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF Cobicistat (High Dose) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF B/F/TAF (Low Dose) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF Cobicistat (Low Dose) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF B/F/TAF (High Dose TOS) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF B/F/TAF (High Dose) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF B/F/TAF (Low Dose TOS) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF) B/F/TAF (High Dose TOS) Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF 3rd ARV Agent Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF ATV Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF) B/F/TAF (High Dose) Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF Nucleos(t)ide reverse transcriptase inhibitors (NRTI) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF DRV Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF Lopinavir Boosted with ritonavir (LPV/r) Participants will continue to take the following study drugs they were taking in the parent study: * Cobicistat (COBI) + DRV + NRTI backbone * COBI + ATV + NRTI backbone * F/TAF + DRV+ COBI * F/TAF + ATV+ COBI * F/TAF + LPV/r * F/TAF + 3rd unboosted agent The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF) B/F/TAF (Low Dose TOS) Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant.
- Primary Outcome Measures
Name Time Method Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study Up to 9.5 Years
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Up to 9.5 Years
Trial Locations
- Locations (12)
University of Zimbabwe Clinical Research Centre
🇿🇼Harare, Zimbabwe
Helios Salud
🇦🇷Buenos Aires, Argentina
Rahima Moosa Mother and Child Hospital
🇿🇦Johannesburg, South Africa
Perinatal HIV Research Unit
🇿🇦Soweto, South Africa
Faculty of Medicine - Mahidol University
🇹ðŸ‡Bangkok Noi, Thailand
Khon Kaen University
🇹ðŸ‡Khon Kaen, Thailand
Hospital del Niño
🇵🇦Panama City, Panama
Enhancing Care Foundation
🇿🇦Durban, South Africa
Be Part Yoluntu Centre
🇿🇦Paarl, South Africa
Joint Clinical Research Centre
🇺🇬Kampala, Uganda
University of Stellenbosch
🇿🇦Cape Town, South Africa
The Aurun Institute
🇿🇦Pretoria, South Africa