safety study of uc-781 vaginal microbicide

Conditions: HIV Infections

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 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

Keywords: microbicides hiv seronegativity