An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 29
- 主要终点
- Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.
排除标准
- •Individuals planning to switch to B/F/TAF on Day 1 with 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 with 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.
研究组 & 干预措施
Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/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.
干预措施: B/F/TAF (Low Dose) (Drug)
Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/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.
干预措施: E/C/F/TAF (Low Dose) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: B/F/TAF (High Dose) (Drug)
Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)
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.
干预措施: B/F/TAF (High Dose) (Drug)
Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)
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.
干预措施: B/F/TAF (High Dose TOS) (Drug)
Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)
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.
干预措施: B/F/TAF (Low Dose TOS) (Drug)
Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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.
干预措施: B/F/TAF (High Dose) (Drug)
Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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.
干预措施: B/F/TAF (Low Dose) (Drug)
Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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.
干预措施: B/F/TAF (High Dose TOS) (Drug)
Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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.
干预措施: 3rd ARV Agent (Drug)
Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/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.
干预措施: B/F/TAF (High Dose) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: F/TAF (High Dose Tablet) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: F/TAF (High Dose TOS) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: F/TAF (Low Dose TOS) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: F/TAF (Lowest Dose TOS) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: B/F/TAF (Low Dose) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: B/F/TAF (High Dose TOS) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: B/F/TAF (Low Dose TOS) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: B/F/TAF (Lowest Dose TOS) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: 3rd ARV Agent (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: ATV (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: DRV (Drug)
Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)
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.
干预措施: B/F/TAF (Lowest Dose TOS) (Drug)
Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/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.
干预措施: E/C/F/TAF (Drug)
Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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.
干预措施: F/TAF (Low Dose Tablet) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: Cobicistat (Low Dose) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: Cobicistat (High Dose) (Drug)
Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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.
干预措施: F/TAF (High Dose Tablet) (Drug)
Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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.
干预措施: F/TAF (Lowest Dose Tablet) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: F/TAF (Lowest Dose Tablet) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: Nucleos(t)ide reverse transcriptase inhibitors (NRTI) (Drug)
Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)
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.
干预措施: B/F/TAF (Low Dose) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: Cobicistat (TOS) (Drug)
Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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.
干预措施: Lopinavir Boosted with ritonavir (LPV/r) (Drug)
结局指标
主要结局
Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study
时间窗: Up to 9.5 Years
次要结局
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)(Up to 9.5 Years)