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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PRO 140 for Human Immunodeficiency Virus Infection

NCT02257788

HIV

WITHDRAWN PHASE2

An Extension of Protocol PRO 140_CD01 Study

NCT02355184

HIV Human Immunodeficiency Virus

TERMINATED PHASE2

Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

NCT02175680

HIV Human Immunodeficiency Virus

COMPLETED PHASE2

An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study

NCT02759042

HIV

NO_LONGER_AVAILABLE

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

NCT06101342

Pre-Exposure Prophylaxis of HIV Infection

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

PRO 140

Group Type EXPERIMENTAL

PRO 140

Intervention Type DRUG

SC injection

Arm 2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRO 140

SC injection

Intervention Type DRUG

Placebo

SC injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No