Overview

This trial is active, not recruiting.

Condition hiv-1 infection
Treatments ftc/rpv/taf, efv/ftc/tdf placebo, efv/ftc/tdf, ftc/rpv/taf placebo
Phase phase 3
Sponsor Gilead Sciences
Start date January 2015
End date June 2016
Trial size 877 participants
Trial identifier NCT02345226, 2014-004779-21, GS-US-366-1160

Summary

This study will evaluate the efficacy and safety of emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) versus continuing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in HIV-1 infected adults who have been virologically suppressed (HIV 1 RNA < 50 copies/mL) on a stable regimen of EFV/FTC/TDF FDC for ≥ 6 consecutive months at screening.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
FTC/RPV/TAF plus EFV/FTC/TDF placebo for 96 weeks. After Week 96, participants will be given option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks.
ftc/rpv/taf Odefsey®
FTC/RPV/TAF (200/25/25 mg) FDC tablets administered orally once daily
efv/ftc/tdf placebo
EFV/FTC/TDF placebo tablets administered orally once daily
(Active Comparator)
EFV/FTC/TDF plus FTC/RPV/TAF placebo for 96 weeks. After Week 96, participants will be given option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks.
ftc/rpv/taf Odefsey®
FTC/RPV/TAF (200/25/25 mg) FDC tablets administered orally once daily
efv/ftc/tdf Atripla®
EFV/FTC/TDF (600/200/300 mg) FDC tablets administered orally once daily
ftc/rpv/taf placebo
FTC/RPV/TAF placebo tablets administered orally once daily

Primary Outcomes

Measure
Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the US FDA-defined snapshot algorithm
time frame: Week 48

Secondary Outcomes

Measure
Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Weeks 48 and 96 as defined by the US FDA-defined snapshot algorithm
time frame: Week 48; Week 96
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 as defined by the US FDA-defined snapshot algorithm
time frame: Week 96
Change from baseline in CD4+ cell count at Weeks 48 and 96
time frame: Baseline;Week 48; Week 96
Percent change from baseline in hip and spine bone mineral density (BMD) at Weeks 48 and 96
time frame: Baseline; Week 48; Week 96
Change from baseline in HIV symptom index score
time frame: Baseline;Week 48; Week 96

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Currently receiving EFV/FTC/TDF FDC for 6 consecutive months preceding the screening visit - Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for 6 months preceding the screening visit. Unconfirmed virologic elevation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable - Have no documented resistance to any of the study agents at any time in the past - HIV-1 RNA < 50 copies/mL at the screening visit - Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN) - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥50,000/mm^3; hemoglobin ≥ 8.5 g/dL) - Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN) - Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant) - Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min according to the Cockcroft-Gault formula Exclusion Criteria: - Hepatitis B surface antigen (HBsAg) positive - Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll) - Individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.) - Females who are breastfeeding - Positive serum pregnancy test - Current alcohol or substance use judged by the Investigator to potentially interfere with the individual's study compliance - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline/Day 1 and must not be anticipated to require systemic therapy during the study - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1 - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements - Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial - Individuals receiving ongoing therapy with any of the following medications in the table below, including drugs not to be used with FTC, RPV and/or TAF (refer to the individual agents Prescribing Information); or individuals with any known allergies to the excipients of FTC/RPV/TAF

Additional Information

Official title A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.