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
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 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

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 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 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

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 July 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.