Trial record 11 of 96 for:
HIV AND substance abuse OR IDU or injection drug user OR drug user OR non-injection drug user | Open Studies | HIV
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
Recruitment status was Recruiting
Sponsor:
Progenics Pharmaceuticals, Inc.
Information provided by:
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01272258
First received: January 5, 2011
Last updated: January 6, 2011
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: PRO 140 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Progenics Pharmaceuticals, Inc.:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 75 |
| Study Start Date: | December 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
PRO 140
|
Drug: PRO 140
SC injection
|
|
Placebo Comparator: Arm 2
Placebo
|
Drug: Placebo
SC injection
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272258
Contacts
| Contact: Sharon Lewis | 215-762-3251 | sharon.lewis@drexelmed.edu |
Locations
| United States, Pennsylvania | |
| Drexel University College of Medicine | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Sharon Lewis 215-762-3251 sharon.lewis@drexelmed.edu | |
| Principal Investigator: Jeff Jacobson, MD | |
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
More Information
No publications provided
| Responsible Party: | Stephen Morris, MD, PhD, Senior Director, Clinical Research, Progenics Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01272258 History of Changes |
| Other Study ID Numbers: | PRO 140 2102 |
| Study First Received: | January 5, 2011 |
| Last Updated: | January 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013