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Sponsors and Collaborators: |
Population Council Centers for Disease Control and Prevention Thai Ministry of Public Health Chiang Rai Public Health Office Chiang Rai District Health Office Chiang Rai Municipal Health Office Chiang Rai Hospital Bill and Melinda Gates Foundation |
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Information provided by: | Population Council |
ClinicalTrials.gov Identifier: | NCT00213057 |
The primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Chlamydia Trachomatis Nesseria Gonorrhea Trichomonas Vaginitis Syphilis |
Drug: Carraguard (PC-515) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Placebo-Controlled, Double-Blind Trial to Assess Expanded Safety and Acceptability of Carraguard™ (PC-515) Vaginal Gel Among Heterosexual Couples in Chiang Rai |
Estimated Enrollment: | 110 |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | June 2002 |
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 primary aims of the study were to assess Carraguard’s safety (toxicity) in both men and women – including signs of local irritation, such as itching or burning; changes in vaginal flora (women); and incidence of abnormal external genital, vaginal (women), and cervical findings (women) – when applied vaginally prior to intercourse for 6 months; to evaluate acceptability; to gauge men’s and women’s reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a Thai population.
Secondary aims were to investigate sexually transmitted infections averted – including HIV, C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications) in men and women; bacterial vaginosis and candidaisis in women; and balanitis in men; and effect on cervical cytology.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
· In good health,
Exclusion Criteria:
· Pregnant or desire to become pregnant at time of study participation,
Thailand | |
Chiang Rai Health Club | |
Chiang Rai, Thailand, 57001 |
Principal Investigator: | Kelly Blanchard, MSc | Population Council |
Study ID Numbers: | Population Council #270, CDC Protocol #2968 |
Study First Received: | September 13, 2005 |
Last Updated: | December 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00213057 |
Health Authority: | United States: Food and Drug Administration; Thailand: Food and Drug Administration |
Microbicides HIV prevention sexually transmitted infections carrageenan |
sero-concordant couples 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 |