Trial Search Results

Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications.

Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: FTC/RPV/TDF
  • Drug: EFV/FTC/TDF

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Ability to understand and sign a written informed consent form

   - Plasma HIV-1 RNA levels ≥ 2,500 copies/mL at screening

   - No prior use of any approved or experimental anti-HIV drug for any length of time

   - Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV
   mutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y

   - Normal ECG

   - Hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase
   [AST]) ≤ 5 x the upper limit of the normal range (ULN)

   - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

   - Adequate hematologic function

   - Serum amylase ≤ 5 x ULN (participants with serum amylase > 5 x ULN remained eligible
   if serum lipase was ≤ 5 x ULN)

   - Adequate renal function

   - 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 non-heterosexually active, practice sexual
   abstinence or have a vasectomized partner) from screening throughout the duration of
   study period and for 12 weeks following the last dose of study drug.

   - Adult (≥ 18 years) males or non-pregnant females

Exclusion Criteria:

   - A new AIDS-defining condition diagnosed within the 30 days prior to screening

   - Females who were breastfeeding

   - Positive serum pregnancy test (female of childbearing potential)

   - Proven or suspected acute hepatitis in the 30 days prior to study entry

   - Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated to
   receive treatment for hepatitis C during the course of the study

   - Subjects experiencing decompensated cirrhosis

   - Had an implanted defibrillator or pacemaker

   - Current alcohol or substance abuse

   - A history of malignancy within the past 5 years or ongoing malignancy other than
   cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous
   squamous carcinoma

   - Active, serious infections requiring parenteral antibiotic or antifungal therapy
   within 30 days prior to baseline

   - Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural
   supplements during the study that are contraindicated or not recommended for use,
   including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with known
   allergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens

   - Participation in any other clinical trial without prior approval from the sponsor was
   prohibited while participating in this trial.

   - Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3
   months of study screening, or expected to receive these agents or systemic steroids
   for immunosuppression during the study (eg, corticosteroids, immunoglobulins, and
   other immune-based or cytokine-based therapies)

   - Had any other clinical condition or prior therapy that, in the opinion of the
   Investigator, would have made the participant unsuitable for the study or unable to
   comply with the dosing requirements

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz
(650) 723-2804
Not Recruiting