Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: HIV-1 Infection

Treatments: Drug: B/F/TAF

Study type: Interventional

Funder types: Industry

Identifiers

NCT03405935

GS-US-380-4449

2017-003428-61 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.

Enrollment: 86 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine [FTC]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 [NCT02616783]) for ≥ 3 months
• Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 [NCT02616783]) for the last 2 visits preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
• Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance

Key Exclusion Criteria:

• An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
• Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
• Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

B/F/TAF

Experimental group

Description:

B/F/TAF FDC for at least 96 weeks.

Treatment:

Drug: B/F/TAF