PRO 140 for Human Immunodeficiency Virus

Summary

PRO 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial of observed systemic, 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 to the previous antiretroviral regimen. Eligible subjects (approximately 76) will be randomized 1:1 to receive an optimized background antiretroviral regimen (OBR) plus supervised weekly subcutaneous treatment with either PRO 140 or placebo. Blood samples for safety and efficacy variables will be obtained over the 24 week duration of the study. Safety will be monitored throughout the course of the study.

Timeline

Start

2012-11

Primary completion

2015-02

Completion

2015-02

Drugs

Indications