Status:
WITHDRAWN
PRO 140 for Human Immunodeficiency Virus Infection
Lead Sponsor:
Drexel University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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 w...
Eligibility Criteria
Inclusion
- Males and females, age ≥18 years
- Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
- Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
- Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- Clinically normal resting 12-lead ECG at screening visit
- 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
- CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- 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)
- Chronic hepatitis
- Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
- Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02257788
Start Date
September 1 2014
End Date
February 1 2015
Last Update
March 9 2017
Active Locations (7)
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1
Stanford University (Stanford AIDS Clinical Trials Unit)
Stanford, California, United States, 94304
2
University of Colorado Denver (Colorado ACTU)
Denver, Colorado, United States, 80045
3
Washington University in St. Louis
St Louis, Missouri, United States, 63110
4
University of Rochester Medical Center
Rochester, New York, United States, 14642