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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Progenics Pharmaceuticals, Inc..
Recruitment status was Recruiting

Sponsor:

Information provided by:

Progenics Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01272258

First received: January 5, 2011

Last updated: January 6, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 5, 2011

Last Updated Date

January 6, 2011

Start Date ^ICMJE

December 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01272258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: PRO 140
SC injection
Drug: Placebo
SC injection

Study Arm (s)

Experimental: Arm 1
PRO 140

Intervention: Drug: PRO 140
Placebo Comparator: Arm 2
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sharon Lewis

215-762-3251

sharon.lewis@drexelmed.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01272258

Other Study ID Numbers ^ICMJE

PRO 140 2102

Has Data Monitoring Committee

Responsible Party

Stephen Morris, MD, PhD, Senior Director, Clinical Research, Progenics Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Progenics Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Progenics Pharmaceuticals, Inc.

Verification Date

January 2011

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

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