Overview

Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission

Status:
Completed
Trial end date:
2002-01-01
Target enrollment:
0
Participant gender:
Female
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 preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV. The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; that women would find Carraguard acceptable. The study was not powered to determine effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 efficacy trial.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Population Council
Collaborators:
Bill and Melinda Gates Foundation
FHI 360
Medical Research Council, South Africa
National Institute of Allergy and Infectious Diseases (NIAID)
United States Agency for International Development (USAID)
University of Cape Town
University of Limpopo
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