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

NCT ID: NCT01286740

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-03-31

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.

Conditions

HIV-1 Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FTC/RPV/TDF

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

Group Type: EXPERIMENTAL

FTC/RPV/TDF

Intervention Type: DRUG

Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily

Interventions

FTC/RPV/TDF

Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily

Intervention Type: DRUG

Other Intervention Names

Complera; Eviplera

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Pugatch, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Living Hope Clinical Foundation

Long Beach, California, United States

Peter J. Ruane MD Inc

Los Angeles, California, United States

Anthony Mills MD, Inc.

Los Angeles, California, United States

La Playa Medical Group and Clinical Research

San Diego, California, United States

Dupont Circle Physicians Group, P.C.

Washington D.C., District of Columbia, United States

Whitman Walker Clinic

Washington D.C., District of Columbia, United States

Capital Medical Associates, PC

Washington D.C., District of Columbia, United States

The Kinder Medical Group

Miami, Florida, United States

Orlando Immunology Center

Orlando, Florida, United States

Atlanta ID Group

Atlanta, Georgia, United States

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States

Northstar Medical Center

Chicago, Illinois, United States

Community Research Initiative of New England

Boston, Massachusetts, United States

Be Well Medical Center, P.C.

Berkley, Michigan, United States

Southampton Healthcare, Inc.

St Louis, Missouri, United States

Southwest Infectious Disease Clinical Research, Inc.

Addison, Texas, United States

Central Texas Clinical Research

Austin, Texas, United States

Peter Shalit, M.D.

Seattle, Washington, United States

Countries

United States

Other Identifiers

GS-US-264-0111

Identifier Type: -

Identifier Source: org_study_id