A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Users With Viral Rebound and Documented Poor Adherence
- Registration Number
- NCT01272258
- Lead Sponsor
- CytoDyn, Inc.
- Brief Summary
PRO 140 2102 is a phase 2b, national, multicenter, randomized, double-blind, placebo-controlled study in order to evaluate the safety and efficacy of PRO 140 (anti-CCR5 monoclonal antibody) administered subcutaneously as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Only R5 virus
- HIV-1 RNA > 1,000 copies/mL but < 100,000 copies/mL
- CD4+ lymphocyte counts > 100 cells/μL
- Non-prescription recreational drug use within the previous 6 months
Key
Exclusion Criteria
- Females who are pregnant (positive blood test), lactating, or breastfeeding, or who plan to become pregnant during the study
- Prior use of any CCR5 entry inhibitors
- History of any acquired immune deficiency syndrome (AIDS)-defining illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo Placebo Arm 1 PRO 140 PRO 140
- Primary Outcome Measures
Name Time Method Specific measure that will be used to determine the effect of the interventions: Percentage of subjects without virologic failure at week 24. 24 Weeks Percentage of subjects without virologic failure at week 24.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States