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NCT03631732 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
496
Enrollment target

NCT03631732: Completed Phase 3 study, sponsored by Gilead Sciences.

NCT03631732 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 496 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03631732, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
496 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed African American participants.

Primary Outcome

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Interventions

  • DRUG B/F/TAF
  • DRUG NRTIs
  • DRUG Third Agent

Trial Details

FieldValue
Enrollment Target 496 participants
Start Date 2018-08-28
Est. Completion 2020-08-19
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT03631732 record still lists

NCT03631732 is an interventional study that assigns participants to a tested intervention. The registered 496 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).

The record links to 0 conditions, and to 3 interventions - of which B/F/TAF is the first listed.

NCT03631732 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03631732 about?

NCT03631732 is a clinical study titled "Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants". The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline re...

What is the current status of trial NCT03631732?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 496 participants. The study started on 2018-08-28. Estimated completion is 2020-08-19.

What interventions are being tested in trial NCT03631732?

The interventions under investigation include: B/F/TAF (DRUG), NRTIs (DRUG), Third Agent (DRUG).

Who is sponsoring clinical trial NCT03631732?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03631732's enrollment target sits among peer trials

496 776th of 2000 higher than 1,223 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03631732, the US trial registry maintained by the National Library of Medicine. NCT03631732 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.