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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01272258

Enrollment

Registered

2011-01-07

Start date

2013-12-31

Completion date

2017-02-28

Last updated

2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

DRUGPRO 140

SC injection

DRUGPlacebo

SC injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026