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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This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272258
First Posted: January 7, 2011
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CytoDyn, Inc.
January 5, 2011
January 7, 2011
February 2, 2017
December 2013
January 2017   (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 ]
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: Quadruple (Participant, Care Provider, 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.
 
Withdrawn
0
February 2017
January 2017   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01272258
PRO 140 2102
No
Not Provided
Not Provided
CytoDyn, Inc.
CytoDyn, Inc.
Not Provided
Not Provided
CytoDyn, Inc.
January 2017

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