Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
HIV Infections, Chlamydia Trachomatis, Neisseria Gonorrhoeae
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring microbicides, HIV prevention, sexually transmitted infections, female-initiated protection, carrageenan, expanded safety trial, HIV Seronegativity, HIV
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- University of Cape Town, Department of Community Health
- Medical University of Southern Africa