Status:
COMPLETED
Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide
Lead Sponsor:
Population Council
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Centers for Disease Control and Prevention
Conditions:
HIV Infections
Chlamydia Trachomatis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary aims of the study were to assess the safety and acceptability of PC-515 when applied vaginally at least three times weekly for 12 months. Secondary aims were to gather preliminary data on ...
Detailed Description
Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a triple-masked, randomized, placebo-controlled trial fielded in one site in Chiang Rai, northern Thailand. The...
Eligibility Criteria
Inclusion
- In good health as determined by medical history, physical examination and results of laboratory screening tests
- Aged 18 years or older
- Resident in the area for at least one year and planning to stay for at least 12 months
- HIV-seronegative at baseline
- Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations)
- Able to achieve a score of 80% or better on true-false test of key study concepts
- Able to give informed consent
Exclusion
- Pregnant or desire to become pregnant at time of study participation
- Delivered or aborted a pregnancy within the six weeks prior to screening
- Male sex partner known at enrollment to be HIV positive
- History of surgery on external genitalia, vagina or cervix in the six weeks prior to screening
- Recent history of non-menstrual vaginal bleeding with intercourse
- Clinically detectable genital abnormality (including presence of warts, or a structural or congenital abnormality)
- Clinical suspicion of a reproductive tract infection (RTI), defined as the presence of a genital ulcer visible to the naked eye, an abnormal vaginal discharge or purulent cervicitis, or untreated positive STD result (Women could be enrolled after treatment of identified RTI. Women with persistent genital epithelial disruption, i.e., ulcer, abrasion or fissure, were not eligible.
- Women with other persistent abnormal signs, such as vaginal or cervical discharge, despite treatment of identified RTI, were eligible)
- Abnormal Pap smear (Class II or above)
- History of sensitivity/allergy to latex
- Concurrent participation in another trial of a vaginal product
- Injection of recreational drugs
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2001
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00213031
Start Date
February 1 2000
End Date
December 1 2001
Last Update
August 14 2017
Active Locations (1)
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1
Chiang Rai Health Club
Chiang Rai, Thailand, 57001