Clinical Trials

MainTitle

Efficacy, Safety, and Tolerability of Cenicriviroc (CVC) in Combination With Truvada or Sustiva Plus Truvada in HIV 1-infected, Antiretroviral Treatment-naïve, Adult Patients Infected With Only CCR5-tropic Virus

This study has been completed
Sponsor
Tobira Therapeutics, Inc.


Information provided by (Responsible Party)
Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier
NCT01338883

First received: April 18, 2011
Last updated: July 3, 2013
Last Verified: July 2013
History of Changes
Purpose

Purpose

This is a randomized, double-blind, double-dummy, 48-week, comparative study. Approximately 150 HIV-infected, treatment-naïve patients with CCR5-tropic virus will be stratified by HIV-1 RNA: ≥100,000 copies/mL versus <100,000 copies/mL and will be randomized 2:2:1 to receive:

  • Arm A: CVC 100 mg (2 tablets, 50 mg each) QD + CVC matching placebo (2 tablets) QD + EFV matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD.
  • Arm B: CVC 200 mg (4 tablets, 50 mg each) QD + EFV matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD.
  • Arm C: CVC matching placebo (4 tablets) QD + EFV 600 mg (1 tablet) QHS + FTC/TDF (1
tablet) QD.

Doses of both CVC/placebo and EFV/ placebo will be administered as double-blinded study drug. FTC/TDF will be administered as open-label study drug in a fixed-dose combination formulation (Truvada). CVC/placebo should be taken following breakfast; EFV should be taken on an empty stomach at bedtime.

HIV-1 RNA levels and CD4+ and CD8+ cell counts, percentages, and ratios will be measured at every visit. Samples for viral tropism and resistance testing in case of virologic failure will be collected at Screening and each on-treatment visit.

Biomarkers associated with inflammation and immune activation will be measured at Baseline (predose) and each study visit thereafter, with flow cytometry obtained at weeks 4, 12, 24, 48, and 52.

Fasting metabolic indicators of glucose control (glucose and insulin for HOMA-IR, HbA1c) and fasting lipid profiles (HDL, LDL, total cholesterol, and triglycerides) will be measured at Baseline (predose) and Weeks 4, 12, 24, 48, and 52. Waist-to-hip ratios will be measured at Baseline and Weeks 24 and 48.

Plasma samples will be collected and stored for possible future studies at Baseline (predose) and every visit thereafter.

Condition Intervention Phase
HIV-1 Infection

Drug : Cenicriviroc 100 mg
Drug : Cenicriviroc 200 mg + Truvada
Drug : Sustiva + Truvada
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR 652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV 1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus

Further study details as provided by Tobira Therapeutics, Inc.:

Primary Outcome Measures

  • To determine the percentage of patients who achieve HIV-1 RNA levels below 50 copies/mL at Week 24 [ Time Frame: 24 weeks ]

Enrollment: 143
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: CVC 100 mg + Truvada

Drug: Cenicriviroc 100 mg

100 mg CVC plus Truvada

Experimental: CVC 200 mg + Truvada

Drug: Cenicriviroc 200 mg + Truvada

200 mg CVC plus Truvada

Active Comparator: Sustiva + Truvada

Drug: Sustiva + Truvada

Sustiva plus Truvada

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Selected Inclusion Criteria:

  1. Adult male and female, HIV-1-infected patients 18 years old and older.
  2. Body mass index (BMI) 18 to < 35 kg/m2.
  3. Antiretroviral treatment-naïve. Treatment-naïve is defined as:
    • No prior nonnucleoside reverse transcriptase inhibitor, other than in women who received a single dose of perinatal nevirapine who have no K103 viral mutation.
    • No prior CCR5 antagonist therapy.
    • No more than 10 days of any other prior antiretroviral therapy.
  4. HIV-1 CCR5-tropic-only virus.
  5. Plasma HIV-1 RNA level >/=1,000 copies/mL at first Screening.
  6. CD4 cell count >/=250 cells/mm3 at first Screening.

Selected
  • Exclusion Criteria:
  • Presence of CXCR4- or dual/mixed-tropic HIV-1 virus.
  • Presence of primary resistance mutations or phenotypic resistance to TDF, FTC, or EFV and/or mutations associated with multidrug nucleoside/nucleotide resistance.
  • An active CDC category C disease (except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial).
  • Any historical CD4 count < 200 cells/mm3.
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value Grade > 2 or total bilirubin greater than the upper limit of normal (ULN).
  • History of HIV-2, hepatitis B and/or C, cirrhosis of the liver, or any known active or chronic liver disease. Hepatitis B vaccinated patients are eligible.

    contacts and locations

    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: NCT01338883

    Locations

    United States, Alabama
    University of Alabama at Birmingham
    Birmingham, Alabama, United States, 35294
    United States, Arizona
    Southwest Center for HIV / AIDS
    Phoenix, Arizona, United States, 85006
    United States, California
    AIDS Healthcare Foundation Research Center
    Beverly Hills, California, United States, 90211
    Pacific Oaks Medical Group
    Beverly Hills, California, United States, 90211
    Providence Clinical Research
    Burbank, California, United States, 91505
    AIDS Research Alliance
    Los Angeles, California, United States, 90015
    Peter J Ruane MD Incorporated
    Los Angeles, California, United States, 90036
    Oasis Clinic
    Los Angeles, California, United States, 90059
    Anthony Mills
    Los Angeles, California, United States, 90069
    Orange Coast Medical Group
    Newport Beach, California, United States, 92663
    Stanford University ACTU
    Palo Alto, California, United States, 94304
    University of California at San Francisco
    San Francisco, California, United States, 94110
    Quest Clinical Research
    San Francisco, California, United States, 94115
    United States, District of Columbia
    Georgetown University Hospital
    Washington, District of Columbia, United States, 20007
    Whitman-Walker Clinic
    Washington, District of Columbia, United States, 20009
    United States, Florida
    Midway Immunology and Research Center
    Fort Pierce, Florida, United States, 34982
    Therafirst Medical Center
    Ft. Lauderdale, Florida, United States, 33308
    Gary Richmond
    Ft. Lauderdale, Florida, United States, 33316
    Wohlfeiler, Piperato & Associates, LLC
    Miami Beach, Florida, United States, 33139
    University of Miami School of Medicine
    Miami, Florida, United States, 33136
    Care Resource Inc.
    Miami, Florida, United States, 33137
    Kinder Medical Group
    Miami, Florida, United States, 33137
    Orlando Immunology Center
    Orlando, Florida, United States, 32803
    Health Positive
    Safety Harbor, Florida, United States, 34695
    Treasure Coast Infectious Disease Consultants
    Vero Beach, Florida, United States, 32960
    Triple O Research Institute, PA
    West Palm Beach, Florida, United States, 33401
    United States, Georgia
    AIDS Research Consortium of Atlanta, Inc.
    Atlanta, Georgia, United States, 30308
    Chatham County Health Department
    Savannah, Georgia, United States, 31410
    United States, Massachusetts
    Community Research Initiative of New England
    Boston, Massachusetts, United States, 02215
    United States, Michigan
    Henry Ford Health System
    Detroit, Michigan, United States, 48202
    United States, New Jersey
    ID Care
    Hillsborough, New Jersey, United States, 08844
    United States, New York
    Synergy First Medical PLLC
    Brooklyn, New York, United States, 11230
    Erie County Medical Center Corporation
    Buffalo, New York, United States, 14215
    Jacobi Medical Center
    New York City, New York, United States, 10461
    Bisher Akil, M.D., A Medical Corporation
    New York, New York, United States, 10011
    Aaron Diamond AIDS Research Center
    New York, New York, United States, 10016
    ACRIA
    New York, New York, United States, 10018
    AIDS Care
    Rochester, New York, United States, 14607
    United States, North Carolina
    University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina, United States, 27599
    Rosedale Infectious Disease
    Huntersville, North Carolina, United States, 28078
    United States, Ohio
    University of Cincinnati
    Cincinnati, Ohio, United States, 45267-0405
    United States, Pennsylvania
    University of Pennsylvania Health System
    Philadelphia, Pennsylvania, United States, 19104
    United States, Texas
    North Texas Infectious Diesease Consultants
    Dallas, Texas, United States, 75246
    Therapeutic Concepts
    Houston, Texas, United States, 77004
    The University of Texas Health Science Center at Houston Medical School
    Houston, Texas, United States, 77030
    Puerto Rico
    Univ. of Puerto Rico - ACTU
    San Juan, Puerto Rico, 935
    University of Puerto Rico, School of Medicine, CEMI
    San Juan, Puerto Rico, 935
    Clinical Research P.R., Inc.
    Santurce, Puerto Rico, 909

    Sponsors and Collaborators

    Tobira Therapeutics, Inc.
    More Information

    More Information


    Responsible Party: Tobira Therapeutics, Inc.  
    ClinicalTrials.gov Identifier: NCT01338883   History of Changes  
    Other Study ID Numbers: TBR-652-2-202  
    Study First Received: April 18, 2011  
    Last Updated: July 3, 2013  

    Keywords provided by Tobira Therapeutics, Inc.:

    HIV-1 Infection
    CCR5-tropic
    Anti-retroviral naive

    Additional relevant MeSH terms:
    Infection
    Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
    Efavirenz
    TAK-652

    ClinicalTrials.gov processed this data on January 23, 2020
    This information is provided by ClinicalTrials.gov.