HIV-1-infection
Conditions
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.
Interventions
DRUGF/TAF (High Dose Tablet)
200/25 mg fixed-dose combination (FDC) tablet administered orally
DRUGF/TAF (Low Dose Tablet)
200/10 mg FDC tablet administered orally
DRUGF/TAF (Lowest Dose Tablet)
120/15 mg FDC tablet administered orally
DRUGF/TAF (High Dose TOS)
60/7.5 mg tablet for oral suspension (TOS) administered orally
DRUGF/TAF (Low Dose TOS)
30/3.75 mg TOS administered orally
DRUGF/TAF (Lowest Dose TOS)
15/1.88 mg TOS administered orally
DRUGE/C/F/TAF
150/150/200/10 mg tablet administered orally
90/90/120/6 mg tablet administered orally
DRUGCobicistat (High Dose)
150 mg tablet administered orally
DRUGCobicistat (Low Dose)
90 mg tablet administered orally
DRUGCobicistat (TOS)
30 mg TOS administered orally
DRUGB/F/TAF (High Dose)
50/200/25 mg FDC tablet administered orally
30/120/15 mg FDC tablet administered orally
DRUGB/F/TAF (High Dose TOS)
15/60/7.52 mg TOS administered orally
DRUGB/F/TAF (Low Dose TOS)
7.5/30/3.76 mg TOS administered orally
DRUGB/F/TAF (Lowest Dose TOS)
3.76/15/1.88 mg TOS administered orally
DRUG3rd ARV Agent
A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV/r), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country
DRUGNucleos(t)ide reverse transcriptase inhibitors (NRTI)
NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC)
DRUGATV
Administered according to the prescribing information
DRUGDRV
Administered according to the prescribing information
DRUGLopinavir Boosted with ritonavir (LPV/r)
Administered according to the prescribing information
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. Key
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study | Up to 9.5 Years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Up to 9.5 Years |
Countries
Argentina, Panama, South Africa, Thailand, Uganda, Zimbabwe
Contacts
CONTACTGilead Clinical Study Information Center
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed