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

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

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

Treatments tested in this trial

  • F/TAF (High Dose Tablet)
  • F/TAF (Low Dose Tablet)
  • F/TAF (Lowest Dose Tablet)
  • F/TAF (High Dose TOS)
  • F/TAF (Low Dose TOS)
  • F/TAF (Lowest Dose TOS)
  • E/C/F/TAF
  • E/C/F/TAF (Low Dose)
  • Cobicistat (High Dose)
  • Cobicistat (Low Dose)
  • Cobicistat (TOS)
  • B/F/TAF (High Dose)
  • B/F/TAF (Low Dose)
  • B/F/TAF (High Dose TOS)
  • B/F/TAF (Low Dose TOS)
  • B/F/TAF (Lowest Dose TOS)
  • 3rd ARV Agent
  • Nucleos(t)ide reverse transcriptase inhibitors (NRTI)
  • ATV
  • DRV
  • Lopinavir Boosted with ritonavir (LPV/r)

Treatment groups

350 Participants
are divided into 4 treatment groups

Sponsors and collaborators