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

July 3, 2013 updated by: Tobira Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  1. Presence of CXCR4- or dual/mixed-tropic HIV-1 virus.
  2. Presence of primary resistance mutations or phenotypic resistance to TDF, FTC, or EFV and/or mutations associated with multidrug nucleoside/nucleotide resistance.
  3. An active CDC category C disease (except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial).
  4. Any historical CD4 count < 200 cells/mm3.
  5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value Grade > 2 or total bilirubin greater than the upper limit of normal (ULN).
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tobira Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBR-652-2-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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