Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01338883 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Tobira Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 143
- Enrollment target
NCT01338883: Completed Phase 2 study, sponsored by Tobira Therapeutics.
NCT01338883 is a Phase 2 study that has completed, run by Tobira Therapeutics. The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01338883, a Phase 2 study, has completed, sponsored by Tobira Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 143 participants
- Enrollment target
Study 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: * 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.
Interventions
- DRUG Cenicriviroc 100 mg
- DRUG Cenicriviroc 200 mg + Truvada
- DRUG Sustiva + Truvada
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01338883 record still lists
NCT01338883 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Cenicriviroc 100 mg is the first listed.
NCT01338883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01338883 about?
NCT01338883 is a clinical study titled "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 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 (...
What is the current status of trial NCT01338883?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2011-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01338883?
The interventions under investigation include: Cenicriviroc 100 mg (DRUG), Cenicriviroc 200 mg + Truvada (DRUG), Sustiva + Truvada (DRUG).
Who is sponsoring clinical trial NCT01338883?
This trial is sponsored by Tobira Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01338883's enrollment target sits among peer trials
143 507th of 2000 higher than 1,494 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01861106 · 144 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations
- NCT03482245 · 144 participants · NA
The Role of Circadian Clock Proteins in Innate and Adaptive Immunity
- NCT03504683 · 144 participants · NA
MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
- NCT03905603 · 144 participants · Early Phase 1
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia