Status:
COMPLETED
Safety and Acceptability of Carraguard® in HIV Positive Women and Men
Lead Sponsor:
Population Council
Collaborating Sponsors:
Centers for Disease Control and Prevention
Medical Research Council
Conditions:
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The study objectives were to assess the mucosal safety of Carraguard® gel when applied vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive women; to evaluate the...
Detailed Description
We proposed a safety study of the Council's lead candidate microbicide, Carraguard® in three cohorts in Durban, South Africa: sexually abstinent HIV-positive women, sexually abstinent HIV-positive men...
Eligibility Criteria
Inclusion
- Positive for HIV-1 by licensed HIV test (with confirmation) and agree to be informed of the test result
- Age 18 to 45 years old, for women (no maximum age for men)
- In good health, defined as CD4+ cell count \>200 x 106/L and current absence of opportunistic infections that may interfere with protocol adherence
- If on treatment for HIV infection (including immune-boosters such as Moducare and vitamins): treatment should stay constant for the duration of the study
- For sexually abstinent cohort: Willing to abstain from sexual intercourse and masturbation for the duration of the study (3 weeks) and for the 48 hours before joining the study
- For sexually active cohort: Willing to have sex with only one male partner, and male partner is willing to have sex with only the participant, for the duration of the study
- Regular menstrual cycle (3-5 weeks between periods) or amenorrheic due to long-term (three months or more) DMPA use (and have had no DMPA-related side effects that could interfere with study participation in the last 6 months)
- Planning on living in Durban for the next 6 months
- Willing to refrain from using any other vaginal products for the duration of the study (3 weeks), including other spermicides, diaphragm/cervical cap, traditional drying and tightening agents, douches, tampons, and medicinal products
- Willing and able to comply with all other aspects of the study protocol, including clinical evaluations and study gel administration (if applicable)
- Willing and able to give informed consent.
Exclusion
- Currently pregnant, menopausal or lactating, or desire to become pregnant at the time of study participation
- Current or recent participation (within past 30 days) in any other clinical trial, including trials of HIV therapeutics and trials of vaginal products (this does not include the ongoing study in the Department of Paediatrics of King Edward VIII Hospital)
- Delivery, miscarriage or abortion within the last six weeks
- Gynecological surgery or instrumentation in the last three months
- History of non-menstrual vaginal bleeding with intercourse in the last month
- Presence of a clinically detectable genital abnormality (i.e. vulvar, vaginal, cervical and/or perianal ulcer and/or lesion) on which the epithelium is currently disrupted or is likely to disrupt (e.g. herpes blister). Women with healed/dried-up lesions from a past infection, or with a lesion on which the epithelium is currently intact or unlikely to disrupt, will be eligible for enrollment.
- Presence of a sexually transmitted infection (STI), symptomatic yeast infection, or bacterial vaginosis (BV), as diagnosed by clinical exam or laboratory testing at screening. Women with asymptomatic yeast infection or BV may be enrolled.
- Abnormal Pap smear (CIN I or higher) at screening
- Use of any spermicide or spermicidally lubricated condom within the week prior to enrollment.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2003
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00213005
Start Date
June 1 2002
End Date
August 1 2003
Last Update
August 14 2017
Active Locations (1)
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1
Medical Research Council
Durban, South Africa