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

CytoDyn

Status and phase: Withdrawn; Phase 2

Conditions: HIV

Treatments: Drug: Placebo; Drug: PRO 140

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272258

PRO 140 2102

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Only R5 virus
2. HIV-1 RNA > 1,000 copies/mL but < 100,000 copies/mL
3. CD4+ lymphocyte counts > 100 cells/μL
4. Non-prescription recreational drug use within the previous 6 months

Key Exclusion Criteria:

1. Females who are pregnant (positive blood test), lactating, or breastfeeding, or who plan to become pregnant during the study
2. Prior use of any CCR5 entry inhibitors
3. History of any acquired immune deficiency syndrome (AIDS)-defining illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

PRO 140

Treatment:

Drug: PRO 140

Arm 2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo