Status:
COMPLETED
PRO 140 by IV Administration in Adults With HIV-1 Infection
Lead Sponsor:
CytoDyn, Inc.
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is: 1. To assess and characterize the PK and PD of PRO 140 administered IV 2. To assess the antiviral activity of PRO 140 3. To assess the safety and tolerability of PRO 140
Eligibility Criteria
Inclusion
- Males \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
- Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- CD4+ T-lymphocyte cell count ≥ 300 cells/mm3 and no documented count \< or = 250 cells/mm3
- Has not taken any anti-retroviral therapy (ART) w/in 12 wks of Early Screening Visit
- Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
- Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
- Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit \& a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, \& be non-lactating. Male \& female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.
Exclusion
- CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
- Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
- History of active hepatitis within the previous 24 wks
- Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, experimental or approved.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00613379
Start Date
December 1 2007
End Date
August 1 2008
Last Update
July 15 2016
Active Locations (1)
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1
Progenics Pharmaceuticals, Inc
Tarrytown, New York, United States, 10591