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
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ClinicalTrials.gov Identifier: NCT01272258
Recruitment Status :
(Lack of enrollment)
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Observed Systemic, Long-Acting, Anti-HIV Treatment With a Monoclonal Anti 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
Study Start Date :
Estimated Primary Completion Date :
Estimated Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key 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