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PRO 140 for Human Immunodeficiency Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438345
Recruitment Status : Withdrawn
First Posted : May 8, 2015
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Drexel University

Brief Summary:
PRO 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial of observed systemic, 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 to the previous antiretroviral regimen. Eligible subjects (approximately 76) will be randomized 1:1 to receive an optimized background antiretroviral regimen (OBR) plus supervised weekly subcutaneous treatment with either PRO 140 or placebo. Blood samples for safety and efficacy variables will be obtained over the 24 week duration of the study. Safety will be monitored throughout the course of the study.

Condition or disease Intervention/treatment Phase
HIV Biological: PRO 140 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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 CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Recreational Drug Users With Viral Rebound and Poor Adherence to the Previous Antiretroviral Regimen
Actual Study Start Date : November 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Treatment Arm 1
PRO 140: one SC dose, 350 mg, weekly for 24 weeks
Biological: PRO 140
Humanized monoclonal antibody to CCr5

Placebo Comparator: Treatment Arm 2
PRO 140: one SC dose, placebo, weekly for 24 weeks
Biological: PRO 140
Humanized monoclonal antibody to CCr5




Primary Outcome Measures :
  1. Percentage of subjects without virologic failure at week 24 [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
  2. Males and females, age ≥ 18 years
  3. Screening plasma HIV-1 RNA > 1,000 copies/mL confirmed by second test while on the current antiretroviral regimen
  4. History of non-prescription injection and/or non-injection recreational drug use
  5. CD4 lymphocyte cell counts > 100 cells/mm3
  6. Clinically normal resting 12-lead ECG at screening visit
  7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through week 24.
  8. Non-adherent, history of poor adherence to a previous antiretroviral regimen.

Exclusion Criteria:

  1. CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
  2. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  3. Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
  4. Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
  5. Participation in an experimental drug trial(s) within 30 days of the early screening visit or during the study

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): NCT02438345


Locations
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United States, Pennsylvania
Drexel University
Phildadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
National Institute on Drug Abuse (NIDA)
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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT02438345    
Other Study ID Numbers: PRO 140 2102
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: January 2016
Additional relevant MeSH terms:
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PRO-140 monoclonal antibody
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents