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PRO 140 for Human Immunodeficiency Virus

NCT02438345 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

PRO 140

Humanized monoclonal antibody to CCr5

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Drexel University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

More Related Trials

Entities

Diseases

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 NCT02438345 on ClinicalTrials.gov