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Sponsors and Collaborators: |
Population Council Bill and Melinda Gates Foundation Family Health International National Institute of Allergy and Infectious Diseases (NIAID) Medical Research Council, South Africa University of Cape Town University of Limpopo United States Agency for International Development (USAID) |
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Information provided by: | Population Council |
ClinicalTrials.gov Identifier: | NCT00213018 |
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.
Condition | Intervention | Phase |
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HIV Infections Chlamydia Trachomatis Neisseria Gonorrhoeae Trichomonas Vaginitis Syphilis |
Drug: Carraguard (PC-515) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission |
Estimated Enrollment: | 400 |
Study Start Date: | October 1999 |
Estimated Study Completion Date: | January 2002 |
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 the study were to assess Carraguard’s safety (toxicity) – including signs of irritation, such as itching or burning; changes in vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings – when applied vaginally for durations of 6-12 months, and to evaluate several dimensions of the acceptability of Carraguard and placebo products. Secondary aims were to investigate whether study participants using Carraguard had lower rates of HIV seroconversion or other sexually transmitted infections (including C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum) than the placebo (methyl cellulose gel). In addition, when it began, this trial was the first to explore the feasibility of large-scale microbicides testing in a non-sex worker population. Last, the trial gauged women’s reactions to using a non-contraceptive product (in vitro testing had shown that Carraguard has no contraceptive effect), as well as potential use-dynamics in communities where drying agents and other traditional vaginal products are used with high frequency.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
South Africa | |
Medical University of Southern Africa | |
Soshanguve, South Africa, 0204 | |
University of Cape Town, Department of Community Health | |
Cape Town, South Africa, 7925 |
Principal Investigator: | Charlotte E. Ellertson, MPA, Ph.D. | Population Council |
Study ID Numbers: | Population Council #210, RO1-AI45468-02 |
Study First Received: | September 13, 2005 |
Last Updated: | October 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00213018 |
Health Authority: | United States: Food and Drug Administration; South Africa: Medicines Control Council |
microbicides HIV prevention sexually transmitted infections female-initiated protection |
carrageenan expanded safety trial HIV Seronegativity HIV |
Bacterial Infections Protozoan Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Vaginitis Trichomonas Infections Vaginal Diseases Genital Diseases, Male Immunologic Deficiency Syndromes Gram-Negative Bacterial Infections Genital Diseases, Female |
Virus Diseases HIV Infections Chlamydia Infections Sexually Transmitted Diseases Parasitic Diseases Gonorrhea Trichomonas Vaginitis Syphilis Retroviridae Infections Neisseriaceae Infections |
Sexually Transmitted Diseases, Bacterial RNA Virus Infections Treponemal Infections Slow Virus Diseases Immune System Diseases |
Spirochaetales Infections Lentivirus Infections Sarcomastigophora Infections Mastigophora Infections Infection |