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
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Drug: emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Drug: efavirenz/emtricitabine/tenofovir disoproxil fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 700
Study Start Date: February 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EFV/FTC/TDF single tablet regimen
Single tablet regimen of efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
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®
Experimental: FTC/RPV/TDF single tablet regimen
Single tablet regimen of emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309243

  Show 149 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Chair: Todd Fralich, M.D. Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01309243     History of Changes
Other Study ID Numbers: GS-US-264-0110
Study First Received: March 3, 2011
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV
HIV-1
Antiretroviral Treatment-Naïve

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Tenofovir disoproxil
Efavirenz
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 18, 2013