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

HIV Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01272258
• Other study ID #: PRO 140 2102
• Status: Withdrawn
• Phase: Phase 2
• First received: January 5, 2011
• Last updated: January 31, 2017
• Start date: December 2013
• Est. completion date: February 2017

Study information

• Verified date: January 2017
• Source: CytoDyn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• PRO 140
SC injection
• Placebo
SC injection

Locations

Country	Name	City	State
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CytoDyn, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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