Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01533259
First received: February 2, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus FTC/TDF at baseline in maintaining HIV-1 RNA <50 copies/mL at Week 12.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections
Drug: EVG/COBI/FTC/TDF
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3B Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) Single-Tablet Regimen (STR) in Virologically Suppressed, HIV-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • HIV-1 RNA < 50 copies/mL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The primary endpoint is HIV-1 RNA < 50 copies/mL at Week 12


Enrollment: 48
Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVG/COBI/FTC/TDF
Switch to the STR consisting of EVG/COBI/FTC/TDF for 48 weeks (n=50)
Drug: EVG/COBI/FTC/TDF
EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily with a meal

Detailed Description:

Open label, multicenter, pilot study to evaluate the efficacy and safety of EVG/COBI/FTC/TDF STR in virologically-suppressed HIV-1 infected subjects who have been on a stable regimen of Raltegravir twice daily plus FTC/TDF for ≥ 6 months at screening and have decided on a change in treatment to simplify daily regimen.

  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
  • Virologically stable on the current first antiretroviral regimen consisting only of Raltegravir twice daily plus FTC/TDF continuously for ≥ 6 months preceding the screening visit and

    • have documented undetectable plasma HIV-1 RNA levels ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and
    • have never experienced two consecutive HIV-1 RNA above detectable levels after first achieving a confirmed HIV-1 RNA level below detectable levels on the first regimen
  • HIV-1 RNA <50 copies/mL at the screening visit
  • Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents at any time
  • Normal ECG
  • Hepatic transaminases ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Estimated glomerular filtration rate ≥ 70 mL/min
  • Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner from screening throughout the duration of the study period and for 30 days following the last dose of study drug
  • Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
  • Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or must be non heterosexually active, practice sexual abstinence, or be vasectomized
  • Age ≥ 18 years

Exclusion Criteria:

  • New AIDS defining condition diagnosed within the 21 days prior to screening
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Subjects with acute or chronic hepatitis B or hepatitis C co-infection
  • Subjects experiencing decompensated cirrhosis
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance abuse that would interfere with compliance
  • 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 21 days prior to the Baseline visit
  • Receiving any investigational drugs
  • Participation in any other clinical trial without prior approval from the sponsor
  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
  • Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
  • 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 EVG/COBI/FTC/TDF; or subjects with known allergies to the excipients of the EVG/COBI/FTC/TDF single tablet regimen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533259

Locations
United States, California
Anthony Mills MD, Inc
Los Angeles, California, United States, 90069
Kaiser Permanente Los Angeles
Los Angeles, California, United States, 90027
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
United States, District of Columbia
Dupont Circle Physician's Group
Washington, District of Columbia, United States, 20009
Capital Medical Associates, PC
Washington, District of Columbia, United States, 20036
United States, Florida
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Massachusetts
Community Research Initiative of New England
Boston, Massachusetts, United States, 02215
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Gordon E. Crofoot, MD, PA
Houston, Texas, United States, 77098
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Huyen Cao, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01533259     History of Changes
Other Study ID Numbers: GS-US-236-0123
Study First Received: February 2, 2012
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV-1
HIV
Treatment Experienced

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

ClinicalTrials.gov processed this record on November 20, 2014