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

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2015 by CytoDyn, Inc.

Sponsor:

Information provided by (Responsible Party):

CytoDyn, Inc.

ClinicalTrials.gov Identifier:

NCT01272258

First received: January 5, 2011

Last updated: November 17, 2015

Last verified: November 2015

History of Changes

Purpose

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	Intervention	Phase
HIV	Drug: PRO 140 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by CytoDyn, Inc.:

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. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Percentage of subjects without virologic failure at week 24.


Estimated Enrollment:	79
Study Start Date:	December 2013
Estimated Study Completion Date:	February 2017
Estimated Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 PRO 140	Drug: PRO 140 SC injection
Placebo Comparator: Arm 2 Placebo	Drug: Placebo SC injection

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272258

Contacts


Contact: Sharon Lewis	215-762-3251	sharon.lewis@drexelmed.edu

Locations


United States, Pennsylvania
Drexel University College of Medicine	Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Sharon Lewis 215-762-3251 sharon.lewis@drexelmed.edu
Principal Investigator: Jeff Jacobson, MD

Sponsors and Collaborators

CytoDyn, Inc.

More Information


Responsible Party:	CytoDyn, Inc.
ClinicalTrials.gov Identifier:	NCT01272258 History of Changes
Other Study ID Numbers:	PRO 140 2102
Study First Received:	January 5, 2011
Last Updated:	November 17, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


HIV Antibodies Physiological Effects of Drugs HIV Fusion Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents	Anti-Infective Agents Antibodies PRO-140 monoclonal antibody Immunologic Factors Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016

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