Clinical Drug Experience Knowledgebase

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