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NCT01474954 · ClinicalTrials.gov registry record
Investigation of The Effect of Cenicriviroc (CVC) Plus FTC/TDF on Cardiovascular Disease Risk Factors
A clinical trial, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- 5
- Enrollment target
NCT01474954: Clinical Trial study, sponsored by University of California, San Francisco.
NCT01474954 is a clinical trial that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01474954 was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- 5 participants
- Enrollment target
Study Summary
This is a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors", open to all patients enrolled in the primary study, "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", in the San Francisco Bay area to evaluate changes in brachial flow mediated dilation in patients in one of three treatment groups: 1. Cenicriviroc (CVC) at 100mg (2 tablets, 50mg each) QD + CVC matching placebo (2 tablets) QD + Efavirenz (EFV) matching placebo (1 capsule) QHS + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1 tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS + FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS + FTC/TDF (1 tablet) QD. The substudy will run for the duration of the primary study. 50 patients of the 150 total enrolled in the primary study will be referred to and enrolled in the cardiovascular substudy. Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment. Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study. The primary study is a randomized, double-blind, double-dummy, 48-week, comparative study in approximately 150 HIV-1-infected, treatment-naïve patients with CCR5-tropic virus. Patients will be stratified by Screening HIV-1 RNA level (≥100,000 copies/mL versus \<100,000 copies/mL) and randomized 2:2:1 to one of the three treatment groups. Patients will receive all medications from the primary study, and thus the primary study site will be responsible for any adverse outcomes with the drug.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-12 |
Why NCT01474954 stopped before completion
NCT01474954 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01474954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01474954 about?
NCT01474954 is a clinical study titled "Investigation of The Effect of Cenicriviroc (CVC) Plus FTC/TDF on Cardiovascular Disease Risk Factors". This is a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors", open to all patients enrolled in the primary study, "A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses o...
What is the current status of trial NCT01474954?
This trial is currently terminated. The enrollment target is 5 participants. The study started on 2011-09. Estimated completion is 2012-12.
Who is sponsoring clinical trial NCT01474954?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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