Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PRO 140 for Human Immunodeficiency Virus Infection

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: NCT02257788
Recruitment Status : Withdrawn (Unlikely to achieve targeted accrual)
First Posted : October 6, 2014
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Drexel University

Brief Summary:
PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.

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

Detailed Description:
Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRO 140 2103: A Phase 2a, Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
Study Start Date : September 2014
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 (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Biological: PRO 140
Humanized monoclonal antibody to CCR5

Active Comparator: Treatment Arm 2
PRO 140: one SC loading dose, 700 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Biological: PRO 140
Humanized monoclonal antibody to CCR5

Active Comparator: Treatment Arm 3
PRO 140: one SC loading dose, 700 mg (day 1), followed by one single SC dose 350 mg (day 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Biological: PRO 140
Humanized monoclonal antibody to CCR5

Active Comparator: Treatment Arm 4
PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Biological: PRO 140
Humanized monoclonal antibody to CCR5




Primary Outcome Measures :
  1. Maximum change in viral load following initiation of different dosing regimens of PRO140 [ Time Frame: 59 days ]
    Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Males and females, age ≥18 years
  2. Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
  3. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
  4. CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
  5. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
  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 three weeks after the last administered subcutaneous dose of PRO 140.

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. Chronic hepatitis
  5. Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
  6. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

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): NCT02257788


Locations
Layout table for location information
United States, California
Stanford University (Stanford AIDS Clinical Trials Unit)
Stanford, California, United States, 94304
United States, Colorado
University of Colorado Denver (Colorado ACTU)
Denver, Colorado, United States, 80045
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Health Science Center at Houston (Houston AIDS Research team (HART)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Drexel University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Study Chair: Jeffrey Jacobson, MD Drexel University
Layout table for additonal information
Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT02257788    
Other Study ID Numbers: 1210001606
5U01AI095085-03 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
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