drugset / Trial / NCT01092104
A Proof of Concept Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A double-blind, randomized, placebo-controlled, dose-escalating study to assess the antiviral activity, safety, tolerability, and pharmacokinetics (PK) of the CCR5 antagonist TBR 652 monotherapy dosed orally once daily (QD) for 10 days in HIV 1-infected, antiretroviral treatment-experienced, CCR5 antagonist-naïve patients.
Timeline
- Start
- 2009-02
- Primary completion
- 2009-11
- Completion
- 2009-11
Publications
- Results Lalezari J, Gathe J, Brinson C, Thompson M, Cohen C, Dejesus E, Galindez J, Ernst JA, Martin DE, Palleja SM. Safety, efficacy, and pharmacokinetics of TBR-652, a CCR5/CCR2 antagonist, in HIV-1-infected, treatment-experienced, CCR5 antagonist-naive subjects. J Acquir Immune Defic Syndr. 2011 Jun 1;57(2):118-25. doi: 10.1097/QAI.0b013e318213c2c0.
- Results Marier JF, Trinh M, Pheng LH, Palleja SM, Martin DE. Pharmacokinetics and pharmacodynamics of TBR-652, a novel CCR5 antagonist, in HIV-1-infected, antiretroviral treatment-experienced, CCR5 antagonist-naive patients. Antimicrob Agents Chemother. 2011 Jun;55(6):2768-74. doi: 10.1128/AAC.00713-10. Epub 2011 Apr 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cenicriviroc | Small molecule | 25 mg | Oral |
| Subject | Cenicriviroc | Small molecule | 50 mg | Oral |
| Subject | Cenicriviroc | Small molecule | 75 mg | Oral |
| Subject | Cenicriviroc | Small molecule | 100 mg | Oral |
| Subject | Cenicriviroc | Small molecule | 150 mg | Oral |