Status:
COMPLETED
A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women
Lead Sponsor:
Population Council
Collaborating Sponsors:
Centers for Disease Control and Prevention
National Center for HIV STD and TB Prevention
Conditions:
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited from general medical clinics, family planning clinics, groups/organizations working with persons living with...
Detailed Description
Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a randomized, controlled trial in Chiang Rai, northern Thailand. Safety of daily product use determined by symp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00213044
Start Date
March 1 2003
End Date
June 1 2004
Last Update
August 15 2017
Active Locations (1)
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1
Chiang Rai Health Club
Chiang Rai, Thailand, 57001