Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Self-describes as Black, African American, or mixed race, including Black
  • Currently receiving an ARV regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months
  • Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, PI or the CCR5 antagonist, maraviroc.
  • If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded.
  • Baseline regimens containing investigational drugs or > 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI).
  • Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving <50 copies/mL while on an INSTI-containing regimen).
  • History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded.
  • Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit
  • HIV-1 RNA levels < 50 copies/mL at Screening
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance

Exclusion Criteria

  • History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT
  • No desire to switch from current antiretrovirals (ARVs)
  • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
  • Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)
  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
  • Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance
  • Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1
  • Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements
  • Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient
  • Females who are pregnant (as confirmed by positive serum pregnancy test)
  • Females who are breastfeeding
  • Acute hepatitis in the 30 days prior to randomization
  • Active tuberculosis infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
B/F/TAF
Participants will receive B/F/TAF FDC.
  • Drug: B/F/TAF
    50/200/25 mg FDC tablets administered orally once daily without regard to food
    Other names:
    • Biktarvy®
Active Comparator
Stay on Baseline Regimen
Participants will stay on 2 NRTIs and a third agent until Week 24, with a delayed switch to B/F/TAF FDC at Week 24.
  • Drug: B/F/TAF
    50/200/25 mg FDC tablets administered orally once daily without regard to food
    Other names:
    • Biktarvy®
  • Drug: NRTIs
    NRTIs could include one of the following: Abacavir (ABC) Didanosine (ddI) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4T) Tenofovir alafenamide (TAF) Tenofovir disoproxil fumarate (TDF) Zidovudine (ZDV or AZT) NRTIs will be administered as prescribed until Week 24 without regard to food.
  • Drug: Third Agent
    Third agent could include one of the following: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Delavirdine (DLV) Efavirenz (EFV) Nevirapine (NVP) Rilpivirine (RPV) Integrase inhibitors Dolutegravir (DTG) Elvitegravir (EVG) Raltegravir (RAL) Protease inhibitors (PIs) Atazanavir (ATV) Darunavir (DRV) Lopinavir Nelfinavir NFV) Saquinavir (SQV) Tipranavir (TPV) Third agents will be administered as prescribed without regard to food. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir.

More Details

NCT ID
NCT03631732
Status
Active, not recruiting
Sponsor
Gilead Sciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.