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

A Proof of Concept, Multiple Dose-Escalating 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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Tobira Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	TBR-652	TBR-652 25 mg
DRUG	TBR-652 Matching Placebo	Matching Placebo
DRUG	TBR-652 50 mg	TBR-652 50 mg QD for 10 days
DRUG	TBR-652 75 mg	TBR-652 75 mg QD for 10 days
DRUG	TBR-652 100 mg	TBR-652 100 mg QD for 10 days
DRUG	TBR-652 150 mg	TBR-652 150 mg QD for 10 days

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2010-03-24
• Last updated: 2013-07-10