Health Trials

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

ConditionHIV-1-infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1+
SponsorGilead Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • F/TAF (High Dose Tablet)

    Drug

    200/25 mg fixed-dose combination (FDC) tablet administered orally

  • F/TAF (Low Dose Tablet)

    Drug

    200/10 mg FDC tablet administered orally

  • F/TAF (Lowest Dose Tablet)

    Drug

    120/15 mg FDC tablet administered orally

  • F/TAF (High Dose TOS)

    Drug

    60/7.5 mg tablet for oral suspension (TOS) administered orally

  • F/TAF (Low Dose TOS)

    Drug

    30/3.75 mg TOS administered orally

  • F/TAF (Lowest Dose TOS)

    Drug

    15/1.88 mg TOS administered orally

  • E/C/F/TAF

    Drug

    150/150/200/10 mg tablet administered orally

  • E/C/F/TAF (Low Dose)

    Drug

    90/90/120/6 mg tablet administered orally

  • Cobicistat (High Dose)

    Drug

    150 mg tablet administered orally

  • Cobicistat (Low Dose)

    Drug

    90 mg tablet administered orally

  • Cobicistat (TOS)

    Drug

    30 mg TOS administered orally

  • B/F/TAF (High Dose)

    Drug

    50/200/25 mg FDC tablet administered orally

  • B/F/TAF (Low Dose)

    Drug

    30/120/15 mg FDC tablet administered orally

  • B/F/TAF (High Dose TOS)

    Drug

    15/60/7.52 mg TOS administered orally

  • B/F/TAF (Low Dose TOS)

    Drug

    7.5/30/3.76 mg TOS administered orally

  • B/F/TAF (Lowest Dose TOS)

    Drug

    3.76/15/1.88 mg TOS administered orally

  • 3rd ARV Agent

    Drug

    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

  • Nucleos(t)ide reverse transcriptase inhibitors (NRTI)

    Drug

    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)

  • ATV

    Drug

    Administered according to the prescribing information

  • DRV

    Drug

    Administered according to the prescribing information

  • Lopinavir Boosted with ritonavir (LPV/r)

    Drug

    Administered according to the prescribing information

Treatment groups

350 Participants
are divided into 4 treatment groups
Group A: Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAFExperimental treatment 7 interventions
Group B: Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAFExperimental treatment 4 interventions
Group C: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAFExperimental treatment 18 interventions
Group D: Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study

Time frame
Up to 9.5 Years

Secondary outcomes

1

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to 9.5 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
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