Status:
COMPLETED
Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
Lead Sponsor:
CytoDyn, Inc.
Conditions:
HIV Infections
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion. Study hypothesis: Single intravenous doses of...
Detailed Description
PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CC...
Eligibility Criteria
Inclusion
- Not more than 20% below or 20% above ideal weight for height and estimated frame size
- Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests
Exclusion
- History of clinically significant disease
- History of clinically significant allergies, including drug allergy
- Participated in another clinical trial within the 3 months prior to study entry
- HIV infected
- Hepatitis B or C virus infected
- Active significant infection
- Prior exposure, allergy, or known hypersensitivity to PRO 140
Key Trial Info
Start Date :
April 16 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00110591
Start Date
April 16 2004
End Date
March 31 2008
Last Update
March 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MDS Pharma Services
Lincoln, Nebraska, United States, 68502