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
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ClinicalTrials.gov Identifier: NCT01338883 |
Recruitment Status
:
Completed
First Posted
: April 20, 2011
Last Update Posted
: July 10, 2013
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Tracking Information | |||
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First Submitted Date ICMJE | April 18, 2011 | ||
First Posted Date ICMJE | April 20, 2011 | ||
Last Update Posted Date | July 10, 2013 | ||
Study Start Date ICMJE | June 2011 | ||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
To determine the percentage of patients who achieve HIV-1 RNA levels below 50 copies/mL at Week 24 [ Time Frame: 24 weeks ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT01338883 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | 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 | ||
Official Title ICMJE | 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 | ||
Brief Summary | 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:
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 | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | HIV-1 Infection | ||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
143 | ||
Original Estimated Enrollment ICMJE |
150 | ||
Actual Study Completion Date | June 2013 | ||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Selected Inclusion Criteria:
Selected Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Puerto Rico, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01338883 | ||
Other Study ID Numbers ICMJE | TBR-652-2-202 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Tobira Therapeutics, Inc. | ||
Study Sponsor ICMJE | Tobira Therapeutics, Inc. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Tobira Therapeutics, Inc. | ||
Verification Date | July 2013 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |