Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Age 18-50 years
Plan to stay in the Chiang Rai area for at least four months
HIV-infected, confirmed by Elisa and Western Blot tests
Either has 1) no current sex partner and is planning to be abstinent for the study duration, or 2) has only one, HIV-infected sexual partner1 who is 18 years or older and is willing to give informed consent for confirmatory HIV testing and for the participant=s enrollment in the study. Women who have a steady partner/husband who she will not see during the study period or with whom she is not sexually active will not be required to bring their partner to the clinic for HIV testing and informed consent.
Willing and able to give informed consent
Willing and able to comply with the study protocol, including being tested for HIV and undergoing repeated pelvic and colposcopic examinations
Willing to have male partner asked for informed consent because he will be exposed to study product
Regular menstrual cycles (defined as occurring every 3-5 weeks, lasting 3-5 days) for the prior 3 months; if have amenorrhea or if using depo-provera, participant must have no reported history of vaginal bleeding for the previous 3 months
CD4 count < 5002
Not currently taking antiretroviral medications3
Documented Class I or Class II ("atypical cells seen, usually caused by inflammation") pap smear at screening for study participation
In good health as determined by medical history, physical examination and results of any laboratory screening test, and the discretion of the clinical staff
Able to achieve a score of 80% or better on true-false test of key study concepts. If women score less than 80% the first time they take the test, they may repeat the test at least one day later

Exclusion Criteria:

CD4 count <50
Pregnancy or desire to become pregnant in the next 3-4 months
Delivery, miscarriage, or abortion within six weeks prior to study enrollment
History of surgery on external genitalia, vagina or cervix in the month prior to study enrollment
Existence of a clinically detectable genital abnormality, specifically warts or a congenital abnormality
History of nonmenstrual vaginal bleeding with intercourse in past one month
Current use of tampons, diaphragms, sponges, douching, or other intravaginal products. Women who are willing to abstain from using these products during the study will be included in the study.
Concurrent participation in another trial of a vaginal product
History of sensitivity or allergy to latex products (including gloves)
Presence of epithelial disruption of the labia or genital mucosa visible to the naked eye at enrollment1
Positive test for gonorrhea, chlamydial infection, trichomoniasis, or evidence of untreated syphilis (see section 5.19). Participants with positive tests must be treated and have a negative test of cure to be eligible for enrollment.1
Positive tests for candidiasis or bacterial vaginosis (BV) and symptoms of vaginitis. Women may be enrolled after treatment if they are asymptomatic or have negative tests. Asymptomatic participants with positive tests for candidiasis or BV may be enrolled.