Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

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 PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.

Key facts

Study ID

NCT00110591

Run by

CytoDyn, Inc.

People needed

20

Starts

2004-04-16

Expected to finish

2008-03-31

Last updated by the study team

2023-03-14

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MDS Pharma Services — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.