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

Sponsor

CytoDyn, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01272258

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Drug: PRO 140 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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 :

Dec 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 PRO 140	Drug: PRO 140 SC injection
Placebo Comparator: Arm 2 Placebo	Drug: Placebo SC injection

Arm

Intervention/Treatment

Experimental: Arm 1

PRO 140

Drug: PRO 140

SC injection

Placebo Comparator: Arm 2

Placebo

Drug: Placebo

SC injection

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102

Sponsors and Collaborators

CytoDyn, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CytoDyn, Inc.

ClinicalTrials.gov Identifier:

NCT01272258

Other Study ID Numbers:

PRO 140 2102

First Posted:

Jan 7, 2011

Last Update Posted:

Feb 2, 2017

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Leronlimab

Study Results

No Results Posted as of Feb 2, 2017