Human Immunodeficiency Virus Infection > Nonoxynol-9

A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides

Recruiting in Palo Alto (17 mi)

Overseen By Edward Fuchs, PA-C, MBA

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of HIV microbicide gels or medical procedures, such as flexible sigmoidoscopy.

Eligibility Criteria

Participant Groups

Group I: Normosol-R Experimental Treatment 1 Intervention

Normosol-R, 5 mL, single administration, negative control

Group II: Normosol with simulation, endoscopy and biopsy Experimental Treatment 2 Interventions

Normosol-R, 5 mL following simulation, endoscopy and biopsy

Group III: Nonoxynol-9 Active Control 1 Intervention

Gynol-II, 2% N-9, 5 mL

Find A Clinic Near You

Research locations nearby Select from list below to view details:

The Johns Hopkins Hospital Baltimore, MD

Who is running the clinical trial?

Johns Hopkins University Lead Sponsor

References