Overview

This trial is active, not recruiting.

Condition hiv-1 infection
Treatments ftc/rpv/taf, ftc/rpv/tdf placebo, ftc/rpv/tdf, ftc/rpv/taf placebo
Phase phase 3
Sponsor Gilead Sciences
Start date January 2015
End date June 2016
Trial size 632 participants
Trial identifier NCT02345252, 2014-004545-27, GS-US-366-1216

Summary

This study will evaluate the safety and efficacy of emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) versus continuing emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) FDC in HIV-1 infected adults who are virologically suppressed on a stable regimen of FTC/RPV/TDF for ≥ 6 consecutive months prior to screening.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator, outcomes assessor
Arm
(Experimental)
FTC/RPV/TAF FDC plus FTC/RPV/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
ftc/rpv/tdf placebo
FTC/RPV/TDF placebo tablets administered orally once daily
(Active Comparator)
FTC/RPV/TDF FDC 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/tdf Complera®
FTC/RPV/TDF (200/25/300 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 at Week 48 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: Weeks 48 and 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

Eligibility Criteria

All participants at least 18 years old.

Key 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 FTC/RPV/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. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA ≥ 50 copies/mL followed by resuppression, are allowed - 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 (≤ 26μmol/L), or normal direct bilirubin - Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3 (1.00 GI/L); platelets ≥50,000/mm^3 (50 GI/L); hemoglobin ≥ 8.5 g/dL (85 g/L)) - 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 (1.17 mL/sec) according to the Cockcroft-Gault formula Key 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 subject 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 subject 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 Note: Other Inclusion/Exclusion criteria may apply.

Additional Information

Official title A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Gilead Sciences.