Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR

Phase 2

Completed

Conditions: HIV-1 Infection

Interventions: Drug: FTC/RPV/TDF

Registration Number: NCT01286740

Lead Sponsor: Gilead Sciences

Brief Summary: The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA \< 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

Inclusion Criteria

Ability to understand and sign a written informed consent form
Receiving EFV/FTC/TDF continuously for ≥ 3 months preceding the screening visit
Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 8 weeks prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screening visit
On their first antiretroviral drug regimen, and no HIV-1 RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA < 50 copies/mL
Had a genotype prior to starting FTC/RPV/TDF and no known resistance to any of the study agents
Normal ECG
Hepatic transaminases (AST and ALT) ≤ 5 x 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 x ULN (subjects with serum amylase > 5 x ULN eligible if serum lipase ≤ 5 x ULN)
Adequate renal function (estimated glomerular filtration rate ≥ 50 mL/min according to the Cockcroft-Gault formula)
Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 60 days following the last dose of study drug.
Age ≥ 18 years
Life expectancy ≥ 1 year

Exclusion Criteria

A new AIDS-defining condition diagnosed within 21 days prior to screening
Females who were breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Proven or suspected acute hepatitis in the 21 days prior to study entry
Subjects receiving drug treatment for Hepatitis C, or subjects anticipated to receive treatment for Hepatitis C during the course of the study, or with a history of liver disease
Was experiencing decompensated cirrhosis
Implanted defibrillator or pacemaker
Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapy within 21 days prior to Baseline
All investigational drugs
Ongoing therapy or anticipated need to initiate drugs or herbal/natural supplements during the study that were contraindicated or not recommended for use as indicated in the protocol, including drugs not to be used with FTC, RPV, and TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF STR
Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial
Treatment 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)
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 the dosing requirements

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FTC/RPV/TDF	FTC/RPV/TDF	Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)	Week 12	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)	Week 24	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)	Week 48	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.
Plasma Concentration of RPV and EFV at Week 1	Week 1	The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.
Plasma Concentration of RPV and EFV at Week 2	Week 2	The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.
Plasma Concentration of RPV and EFV at Week 4	Week 4	The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.
Plasma Concentration of RPV and EFV at Week 6	Week 6	The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.
Plasma Concentration of RPV and EFV at Week 8	Week 8	The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.
Plasma Concentration of RPV at Week 12	Week 12	The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.
Plasma Concentration of EFV at Week 12	Week 12	The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12
Plasma Concentration of RPV at Week 24	Week 24	The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.
Plasma Concentration of RPV at Week 36	Week 36	The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.
Plasma Concentration of RPV at Week 48	Week 48	The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.

Trial Locations

Locations (18): Atlanta ID Group
🇺🇸
Atlanta, Georgia, United States
Be Well Medical Center, P.C.
🇺🇸
Berkley, Michigan, United States
Infectious Disease Specialists of Atlanta
🇺🇸
Decatur, Georgia, United States
Capital Medical Associates, PC
🇺🇸
Washington, District of Columbia, United States
Peter J. Ruane MD Inc
🇺🇸
Los Angeles, California, United States
Living Hope Clinical Foundation
🇺🇸
Long Beach, California, United States
Dupont Circle Physicians Group, P.C.
🇺🇸
Washington, District of Columbia, United States
Whitman Walker Clinic
🇺🇸
Washington, District of Columbia, United States
La Playa Medical Group and Clinical Research
🇺🇸
San Diego, California, United States
Community Research Initiative of New England
🇺🇸
Boston, Massachusetts, United States
The Kinder Medical Group
🇺🇸
Miami, Florida, United States
Peter Shalit, M.D.
🇺🇸
Seattle, Washington, United States
Orlando Immunology Center
🇺🇸
Orlando, Florida, United States
Southwest Infectious Disease Clinical Research, Inc.
🇺🇸
Addison, Texas, United States
Northstar Medical Center
🇺🇸
Chicago, Illinois, United States
Anthony Mills MD, Inc.
🇺🇸
Los Angeles, California, United States
Central Texas Clinical Research
🇺🇸
Austin, Texas, United States
Southampton Healthcare, Inc.
🇺🇸
St. Louis, Missouri, United States