Status:
COMPLETED
Safety Study of UC-781 Vaginal Microbicide
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Ministry of Health, Thailand
CONRAD
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.
Eligibility Criteria
Inclusion
- Inclusion Criteria for women:
- Age 18-50 years old
- Regular menses
- HIV-1 seronegative at screening
- Normal Pap smear at screening or documented normal Pap smear within six months prior to screening
- No evidence of reproductive tract infection (RTI)
- Willing and able to comply with study procedures, including pelvic exams, colposcopy, maintaining a study coital and symptom log, and applying assigned study gel per protocol
- Agree to abstain from sexual intercourse for 24 hours prior to the enrollment visit
- Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
- Insertion of fingers and other objects into the vagina
- Receiving oral sex
- Receiving anal sex
- Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
- Using vaginal products other than the study gels, including douches, lubricants, or feminine hygiene products
- In a monogamous sexually active relationship with one male partner
- Report having vaginal intercourse only with that partner at least two times per week
- No other reported partner in the prior six months and no plan to have another partner for the duration of the study
- Agree to use condoms for each act of vaginal intercourse during participation in the study
- Their male partner is informed and also consents to participate in the study
- Willing to have male partner informed and treated if an STD is diagnosed at screening or during the study
- Inclusion Criteria for men:
- Age 18 years or older
- HIV-seronegative and free of other STI at screening exam
- One female sexual partner; no other reported partner in the prior six months and no plan to have another partner for the duration of the study
- Willing and able to comply with study procedures, including clinic visits, interviews and acceptability evaluation, and consistent use of condoms during enrollment in the study
- Willing to have female partner informed and treated if an STD is diagnosed at screening or during the study
- Exclusion Criteria for women:
- Pregnancy or desire to become pregnant at time of study participation
- Currently breastfeeding
- Delivery or abortion within last eight weeks
- History of any male sexual partner other than current partner in past six months
- \- No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including hematology, liver and kidney function
- History of post-coital vaginal bleeding in the past three months
- History of surgery to remove uterus or cervix
- History of surgery on the external genitalia, vaginal, or cervix in the past month
- Clinically significant chronic medical condition that is considered progressive, including cardiopulmonary disease, renal disease, hepatic disease, diabetes mellitus.
- History of sensitivity/allergy to latex
- Existence of a clinically detectable genital abnormality at screening (e.g. ulcer, congenital abnormality, any lesion with mucosal disruption)
- Concurrent participation in another trial of a vaginal product
- Have any other condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
- Exclusion Criteria for men:
- History of genital surgery in the past month
- Clinical or laboratory evidence of an STI.
- History of sensitivity/allergy to latex
- History of any sexual partner other than their current partner in the past six months
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00446979
Start Date
June 1 2007
End Date
October 1 2007
Last Update
April 19 2013
Active Locations (1)
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1
Chiang Rai Health Club
Chiang Rai, Thailand, 57000