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
NCT ID: NCT01338883
Last Updated: 2013-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2011-06-30
2013-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CVC 100 mg + Truvada
Cenicriviroc 100 mg
100 mg CVC plus Truvada
CVC 200 mg + Truvada
Cenicriviroc 200 mg + Truvada
200 mg CVC plus Truvada
Sustiva + Truvada
Sustiva + Truvada
Sustiva plus Truvada
Interventions
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Cenicriviroc 100 mg
100 mg CVC plus Truvada
Cenicriviroc 200 mg + Truvada
200 mg CVC plus Truvada
Sustiva + Truvada
Sustiva plus Truvada
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Tobira Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Southwest Center for HIV / AIDS
Phoenix, Arizona, United States
AIDS Healthcare Foundation Research Center
Beverly Hills, California, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Providence Clinical Research
Burbank, California, United States
AIDS Research Alliance
Los Angeles, California, United States
Peter J Ruane MD Incorporated
Los Angeles, California, United States
Oasis Clinic
Los Angeles, California, United States
Anthony Mills
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
Stanford University ACTU
Palo Alto, California, United States
University of California at San Francisco
San Francisco, California, United States
Quest Clinical Research
San Francisco, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Gary Richmond
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Care Resource Inc.
Miami, Florida, United States
Kinder Medical Group
Miami, Florida, United States
Wohlfeiler, Piperato & Associates, LLC
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Health Positive
Safety Harbor, Florida, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States
Triple O Research Institute, PA
West Palm Beach, Florida, United States
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
ID Care
Hillsborough, New Jersey, United States
Synergy First Medical PLLC
Brooklyn, New York, United States
Erie County Medical Center Corporation
Buffalo, New York, United States
Bisher Akil, M.D., A Medical Corporation
New York, New York, United States
Aaron Diamond AIDS Research Center
New York, New York, United States
ACRIA
New York, New York, United States
Jacobi Medical Center
New York, New York, United States
AIDS Care
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Rosedale Infectious Disease
Huntersville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
North Texas Infectious Diesease Consultants
Dallas, Texas, United States
Therapeutic Concepts
Houston, Texas, United States
The University of Texas Health Science Center at Houston Medical School
Houston, Texas, United States
Univ. of Puerto Rico - ACTU
San Juan, PR, Puerto Rico
University of Puerto Rico, School of Medicine, CEMI
San Juan, PR, Puerto Rico
Clinical Research P.R., Inc.
Santurce, Puerto Rico, Puerto Rico
Countries
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References
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Sherman KE, Abdel-Hameed E, Rouster SD, Shata MTM, Blackard JT, Safaie P, Kroner B, Preiss L, Horn PS, Kottilil S. Improvement in Hepatic Fibrosis Biomarkers Associated With Chemokine Receptor Inactivation Through Mutation or Therapeutic Blockade. Clin Infect Dis. 2019 May 17;68(11):1911-1918. doi: 10.1093/cid/ciy807.
Thompson M, Saag M, DeJesus E, Gathe J, Lalezari J, Landay AL, Cade J, Enejosa J, Lefebvre E, Feinberg J. A 48-week randomized phase 2b study evaluating cenicriviroc versus efavirenz in treatment-naive HIV-infected adults with C-C chemokine receptor type 5-tropic virus. AIDS. 2016 Mar 27;30(6):869-78. doi: 10.1097/QAD.0000000000000988.
Kagan RM, Johnson EP, Siaw MF, Van Baelen B, Ogden R, Platt JL, Pesano RL, Lefebvre E. Comparison of genotypic and phenotypic HIV type 1 tropism assay: results from the screening samples of Cenicriviroc Study 202, a randomized phase II trial in treatment-naive subjects. AIDS Res Hum Retroviruses. 2014 Feb;30(2):151-9. doi: 10.1089/AID.2013.0123. Epub 2013 Aug 14.
Other Identifiers
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TBR-652-2-202
Identifier Type: -
Identifier Source: org_study_id
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