MedTrace Logo

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

NCT01092104 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2013-07-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tobira Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-11-30
Completion
2009-11-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092104 on ClinicalTrials.gov