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-Naïve Adults.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01309243
First received: March 3, 2011
Last updated: May 2, 2012
Last verified: April 2012

March 3, 2011
May 2, 2012
February 2011
July 2012   (final data collection date for primary outcome measure)
The primary efficacy endpoint is the proportion of subjects who achieve HIV 1 RNA < 50 copies/mL at week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01309243 on ClinicalTrials.gov Archive Site
  • The change from baseline in CD4 count in each treatment arm at week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • The change from baseline in CD4 count in each treatment arm at week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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-Naïve Adults.
A Phase 3B, Randomized, Open-label 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-Naïve Adults

The purpose of the study is 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-Naïve Adults. The FTC/RPV/TDF single tablet regimen could offer an alternative treatment option to patients who wish to simplify or improve the tolerability of their treatment but want to avoid using efavirenz due to concerns about central nervous system side effects, rash, elevations in plasma lipids as well as to women of childbearing potential.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
  • Drug: emtricitabine/rilpivirine/tenofovir disoproxil fumarate
    Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg single tablet regimen administered orally with a meal QD
  • Drug: efavirenz/emtricitabine/tenofovir disoproxil fumarate
    Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg single tablet regimen administered orally on an empty stomach preferably at bedtime (QHS)
    Other Name: Atripla®
  • Active Comparator: EFV/FTC/TDF single tablet regimen
    Single tablet regimen of efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
    Intervention: Drug: efavirenz/emtricitabine/tenofovir disoproxil fumarate
  • Experimental: FTC/RPV/TDF single tablet regimen
    Single tablet regimen of emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg
    Intervention: Drug: emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
700
July 2013
July 2012   (final data collection date for primary outcome measure)

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 with the exception of PrEP (pre-exposure prophylaxis).
  • No use of Truvada or Viread for pre-exposure prophylaxis (PrEP) within 30 days of screening.
  • Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations.
  • 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.
  • Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN will remain eligible if serum lipase is ≤ 5 x ULN).
  • Adequate renal function.
  • Males and Females of childbearing potential must agree 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.
  • Life expectancy ≥ 1 year.

Exclusion Criteria:

  • A new AIDS defining condition diagnosed within the 30 days prior to screening with the exception of CD4 count and percentage.
  • Females who are 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 are anticipated to receive treatment for Hepatitis C during the course of the study.
  • Subjects experiencing decompensated cirrhosis.
  • Have 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, TDF, and Atripla®; or subjects with known allergies to the excipients of the FTC/RPV/TDF single tablet regimen and/or Atripla® tablets.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Portugal,   Puerto Rico,   Spain,   Switzerland,   United Kingdom
 
NCT01309243
GS-US-264-0110
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Chair: Todd Fralich, M.D. Gilead Sciences
Gilead Sciences
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP