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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

January 5, 2011
July 25, 2013
December 2013
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01272258 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV
  • Drug: PRO 140
    SC injection
  • Drug: Placebo
    SC injection
  • Experimental: Arm 1
    PRO 140
    Intervention: Drug: PRO 140
  • Placebo Comparator: Arm 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
79
February 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sharon Lewis 215-762-3251 sharon.lewis@drexelmed.edu
United States
 
NCT01272258
PRO 140 2102
No
CytoDyn, Inc.
CytoDyn, Inc.
Not Provided
Not Provided
CytoDyn, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP