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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 is a Phase 2 study that has completed, run by Tobira Therapeutics. The registered enrollment target is 143 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01338883
The ClinicalTrials.gov registry entry for NCT01338883 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tobira Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cenicriviroc 100 mg is the first listed.
NCT01338883 reports 0 study locations.
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.
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