Study Stopped
Lack of enrollment
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2013
Typical duration for phase_2 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 2, 2017
January 1, 2017
3.1 years
January 5, 2011
January 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Specific measure that will be used to determine the effect of the interventions: Percentage of subjects without virologic failure at week 24.
Percentage of subjects without virologic failure at week 24.
24 Weeks
Study Arms (2)
Arm 1
EXPERIMENTALPRO 140
Arm 2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CytoDyn, Inc.lead
Study Sites (1)
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2011
First Posted
January 7, 2011
Study Start
December 1, 2013
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
February 2, 2017
Record last verified: 2017-01