Status:
COMPLETED
Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
Lead Sponsor:
Population Council
Collaborating Sponsors:
Bill and Melinda Gates Foundation
FHI 360
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 Carraguard ™ (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims were to gather pre...
Detailed Description
Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a triple-masked, randomized, placebo-controlled trial fielded in two sites in South Africa. The primary aims of...
Eligibility Criteria
Inclusion
- In good health as determined by medical history, physical examination and results of laboratory screening tests for RTIs
- 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 screening
- Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations), and,
- Able to give informed consent
Exclusion
- Pregnant or desire to become pregnant during the trial
- Delivered or aborted a pregnancy within the six weeks prior to screening
- 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 RTI (defined as the presence of a genital ulcer visible to the naked eye, an abnormal vaginal discharge or purulent cervicitis, or untreated positive STI test result)
- Abnormal Pap smear
- History of sensitivity/allergy to latex
- Participating in another trial of a vaginal product
- Reported injection of recreational drugs
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
January 1 2002
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00213018
Start Date
October 1 1999
End Date
January 1 2002
Last Update
August 14 2017
Active Locations (2)
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1
University of Cape Town, Department of Community Health
Cape Town, South Africa, 7925
2
Medical University of Southern Africa
Soshanguve, South Africa, 0204