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
Public ClinicalTrials.gov record NCT01338883. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01338883
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 143 participants
Conditions and interventions
Conditions
Interventions
- Cenicriviroc 100 mg Drug
- Cenicriviroc 200 mg + Truvada Drug
- Sustiva + Truvada Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2011 (Type not available)
- Primary completion
- Dec 2012 (Actual)
- Completion
- Jun 2013 (Actual)
- Last update posted
- Jul 10, 2013
2011 – 2013
United States locations
- U.S. sites
- 45
- U.S. states
- 14
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Southwest Center for HIV / AIDS | Phoenix | Arizona | 85006 | — |
| AIDS Healthcare Foundation Research Center | Beverly Hills | California | 90211 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| Providence Clinical Research | Burbank | California | 91505 | — |
| AIDS Research Alliance | Los Angeles | California | 90015 | — |
| Peter J Ruane MD Incorporated | Los Angeles | California | 90036 | — |
| Oasis Clinic | Los Angeles | California | 90059 | — |
| Anthony Mills | Los Angeles | California | 90069 | — |
| Orange Coast Medical Group | Newport Beach | California | 92663 | — |
| Stanford University ACTU | Palo Alto | California | 94304 | — |
| University of California at San Francisco | San Francisco | California | 94110 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Whitman-Walker Clinic | Washington D.C. | District of Columbia | 20009 | — |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | — |
| Gary Richmond | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| University of Miami School of Medicine | Miami | Florida | 33136 | — |
| Care Resource Inc. | Miami | Florida | 33137 | — |
| Kinder Medical Group | Miami | Florida | 33137 | — |
| Wohlfeiler, Piperato & Associates, LLC | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Health Positive | Safety Harbor | Florida | 34695 | — |
| Treasure Coast Infectious Disease Consultants | Vero Beach | Florida | 32960 | — |
| Triple O Research Institute, PA | West Palm Beach | Florida | 33401 | — |
| AIDS Research Consortium of Atlanta, Inc. | Atlanta | Georgia | 30308 | — |
| Chatham County Health Department | Savannah | Georgia | 31410 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Synergy First Medical PLLC | Brooklyn | New York | 11230 | — |
| Erie County Medical Center Corporation | Buffalo | New York | 14215 | — |
| Bisher Akil, M.D., A Medical Corporation | New York | New York | 10011 | — |
| Aaron Diamond AIDS Research Center | New York | New York | 10016 | — |
| ACRIA | New York | New York | 10018 | — |
| Jacobi Medical Center | New York | New York | 10461 | — |
| AIDS Care | Rochester | New York | 14607 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Rosedale Infectious Disease | Huntersville | North Carolina | 28078 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0405 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| North Texas Infectious Diesease Consultants | Dallas | Texas | 75246 | — |
| Therapeutic Concepts | Houston | Texas | 77004 | — |
| The University of Texas Health Science Center at Houston Medical School | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01338883, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 10, 2013 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01338883 live on ClinicalTrials.gov.