Phase I Study of Safety and Persistence of UC-781 Vaginal Microbicide

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Vaginal microbicides are compounds that may protect women from HIV and other sexually transmitted infections (STIs). This study will determine the safety of the microbicide UC-781 by comparing the effects of keeping the microbicide in the vagina for different lengths of time.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: CONRAD
• Treatments: Anti-Infective Agents; UC-781

Criteria

Inclusion Criteria for Screening Visit:

• HIV uninfected

• General good health

• Normal Pap smear within 12 months prior to screen or obtained at screening visit

• Anatomy that lends itself easily to visualization of the cervix

• Sexual abstinence (including vaginal, oral, and rectal) from Visit 1 to the completion of Visit 4

• Agree to use condoms provided by the study between Visits 4 and 5

• Agree to abstain from the use of intravaginal products or vaginal penetration throughout the study

• Willing to use acceptable forms of contraception until the completion of study

• Willing to participate in all study-related assessments and follow all study-related procedures

Inclusion Criteria for Study Entry:

• Meet all inclusion criteria for the screening visit at Study Entry

• Willing to stay in the Magee-Womens Hospital Clinical Research Center (MWH CRC) for up to 9 hours after gel insertion

Exclusion Criteria for Screening Visit:

• Menopause (at least 12 months without menses in absence of long-acting progestin use)

• Hysterectomy

• Latex allergy

• Use of a diaphragm, NuvaRing, or spermicide for contraception

• Diagnosed urogenital infection or suspected infection 21 days prior to study screening. More information on this criterion can be found in the protocol.

• Menses or other vaginal bleeding anticipated in the 17 days postscreening

• Antibiotic or antifungal therapy (vaginal or systemic) 14 days prior to study screening

• Injected nontherapeutic drugs 12 months prior to study screening

• Systemic immunosuppressive drug use 60 days prior to study screening

• Participation in drug, spermicide, and/or microbicide study 30 days prior to study screening

• Any condition that, in the opinion of the investigator, would interfere with the study

• Intravaginal use of any device or product (except tampons) 7 days prior to study screening

• Surgical procedure involving the pelvis in the 90 days prior to enrollment (e.g., dilation and curettage or evacuation, cervical biopsy, cryosurgery,any other surgery involving pelvic organs or area)

• Abnormal pelvic exam finding that, in the opinion of the investigator would complicate interpretation of the colposcopy

• Pregnancy, or within 90 days of last pregnancy

• Breastfeeding

Exclusion Criteria for Study Entry:

• Meets any of the exclusion criteria of the screening visit

• Diagnosed or suspected reproductive tract infection or urinary tract infection. More information on this criterion can be found in the protocol.

• Menses or other vaginal bleeding anticipated in the 8 days following study entry

• Injected nontherapeutic drugs between study screening and study entry

• Certain abnormal laboratory values