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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

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ClinicalTrials.gov Identifier: NCT01272258
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : January 7, 2011
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : December 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272258


Locations
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
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
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017

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