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

NCT01286740 | Completed Phase 2 Results

• 1 other identifier: GS-US-264-0111
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 18

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

Keywords

HIV-1; HIV; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)

  The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.

  Week 12

Secondary Outcomes (12)

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)

  Week 24

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)

  Week 48

• Plasma Concentration of RPV and EFV at Week 1

  Week 1

• Plasma Concentration of RPV and EFV at Week 2

  Week 2

• Plasma Concentration of RPV and EFV at Week 4

  Week 4

Study Arms (1)

FTC/RPV/TDF

EXPERIMENTAL

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

Drug: FTC/RPV/TDF

Interventions

FTC/RPV/TDF 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

Also known as: Complera, Eviplera

FTC/RPV/TDF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (18)

Living Hope Clinical Foundation

Long Beach, California, 90814, United States

Location

Peter J. Ruane MD Inc

Los Angeles, California, 90036, United States

Location

Anthony Mills MD, Inc.

Los Angeles, California, 90069, United States

Location

La Playa Medical Group and Clinical Research

San Diego, California, 92103, United States

Location

Dupont Circle Physicians Group, P.C.

Washington D.C., District of Columbia, 20009, United States

Location

Whitman Walker Clinic

Washington D.C., District of Columbia, 20009, United States

Location

Capital Medical Associates, PC

Washington D.C., District of Columbia, 20036, United States

Location

The Kinder Medical Group

Miami, Florida, 33133, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Atlanta ID Group

Atlanta, Georgia, 30309, United States

Location

Infectious Disease Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Northstar Medical Center

Chicago, Illinois, 60657, United States

Location

Community Research Initiative of New England

Boston, Massachusetts, 02215, United States

Location

Be Well Medical Center, P.C.

Berkley, Michigan, 48072, United States

Location

Southampton Healthcare, Inc.

St Louis, Missouri, 63139, United States

Location

Southwest Infectious Disease Clinical Research, Inc.

Addison, Texas, 75001, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Peter Shalit, M.D.

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Emtricitabine, Rilpivirine, Tenofovir Drug Combination

Intervention Hierarchy (Ancestors)

Rilpivirine; Nitriles; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences, Inc.

ClinicalTrialDisclosures@gilead.com

Study Officials

• David Pugatch, MD

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 26, 2013
• Results First Posted: April 19, 2013

Record last verified: 2013-04

Locations

US (18)