Status:
COMPLETED
Phase I Study of Safety and Persistence of UC-781 Vaginal Microbicide
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
CONRAD
Conditions:
HIV Infections
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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 eff...
Detailed Description
Vaginal microbicides are compounds applied to the inside of the vagina that may protect women against vaginal transmission of HIV and other STIs. This study will evaluate the safety of the vaginal mic...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00441909
Start Date
April 1 2006
End Date
April 1 2008
Last Update
March 5 2009
Active Locations (1)
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1
Magee-Womens Hospital of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States