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Cenicriviroc in Treatment-Naïve HIV-1 Infection
NCT01338883Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2011
- Primary completion
- Dec 2012
- Countries
- 2
- Sponsor
- Tobira Therapeutics
- Modality
- Small Molecules
- Drugs
- cenicriviroc
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 2, randomised, double-blind trial of cenicriviroc in human immunodeficiency virus type 1 infection (HIV-1), sponsored by Tobira Therapeutics. Started Jun 2011; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Registry description
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…
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