drugset / Trial / NCT03631732
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-08-28
- Primary completion
- 2019-08-12
- Completion
- 2020-08-19
Outcome
Met primary endpoint
paper 0.6% on B/F/TAF vs 1.8% on SBR had HIV-1 RNA ≥50 copies/mL (difference -1.2%; 95% confidence interval -4.8% to 0.9%), demonstrating noninferiority PMID 34397746 ↗
release “BRAAVE 2020 Study Demonstrates Non-Inferiority of Biktarvy for the Treatment of HIV in Black Americans Who Are Virologically Suppressed” gilead.com ↗
Publications
- Results Andreatta K, D'Antoni ML, Chang S, Parvangada A, Martin R, Blair C, et al. Preexisting Resistance and Week 48 Virologic Outcomes after Switching to B/F/TAF in African American Adults With HIV [Presentation]. IDWeek Virtual; 2020b 21-25 October.
- Results Hagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopol M, McDonald C, Blair C, Andreatta K, Collins SE, Brainard D, Martin H. Week-48 Outcomes From the BRAAVE 2020 Study: a Randomized Switch to B/F/TAF in African-American Adults With HIV, IDWeek 2020, October 21-25. Abstract 1046.
- Results Andreatta K, D'Antoni ML, Chang S, Martin R, Blair C, Collins SE, et al. Preexisting Resistance and B/F/TAF Switch Efficacy in African Americans [Poster 509]. Conference on Retroviruses and Opportunistic Infections (CROI); 2020b 08-11 March; Boston, MA.
- Results Hagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopol M, McDonald C, Blair C, Andreatta K, Collins SE, Brainard D, Martin H. Randomized Switch to B/F/TAF in African American Adults with HIV. Conference on Retroviruses and Opportunistic Infections 2020, March 7-11, Boston MA. Abstract 2979.
- Results Hagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopal MN, McDonald C, Blair C, Andreatta K, Collins SE, Brainard DM, Martin H; BRAAVE2020 Investigators. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study. J Acquir Immune Defic Syndr. 2021 Sep 1;88(1):86-95. doi: 10.1097/QAI.0000000000002731.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abacavir | Other / unclassified | — | — |
| Comparator | Atazanavir | Other / unclassified | — | — |
| Subject | Bictegravir | Small molecule | 50 mg | Oral |
| Comparator | Darunavir | Small molecule | — | — |
| Comparator | Delavirdine | Small molecule | — | — |
| Comparator | Dolutegravir | Other / unclassified | — | — |
| Comparator | Doravirine | Small molecule | — | — |
| Comparator | Efavirenz | Other / unclassified | — | — |
| Comparator | Lamivudine | Other / unclassified | — | — |
| Comparator | Lopinavir | Other / unclassified | — | — |
| Comparator | Maraviroc | Other / unclassified | — | — |
| Comparator | Nelfinavir | Other / unclassified | — | — |
| Comparator | Nevirapine | Small molecule | — | — |
| Comparator | Raltegravir | Other / unclassified | — | — |
| Comparator | Rilpivirine | Small molecule | — | — |
| Comparator | Saquinavir | Small molecule | — | — |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Comparator | Tipranavir | Small molecule | — | — |
| Comparator | Zidovudine | Small molecule | — | — |
| Comparator | elvitegravir | Small molecule | — | — |
| Comparator | emtricitabine | Other / unclassified | 200 mg | Oral |
| Comparator | emtricitabine | Other / unclassified | — | — |
| Comparator | tenofovir alafenamide | Small molecule | 25 mg | Oral |
| Comparator | tenofovir alafenamide | Small molecule | — | — |
| Comparator | Cobicistat | Small molecule | — | — |
| Comparator | Ritonavir | Other / unclassified | — | — |