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 not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by CytoDyn, Inc.
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT01272258
First received: January 5, 2011
Last updated: July 25, 2013
Last verified: July 2013
  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:


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 2015
Estimated Primary Completion Date: January 2015 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 Not yet 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

No publications provided

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: July 25, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 01, 2014