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Sponsors and Collaborators: |
Population Council Bill and Melinda Gates Foundation Centers for Disease Control and Prevention Nat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention—Surveillance & Epidemiology National Center for Infectious Diseases,Division of AIDS, STD and TB Lab. Research Thai Ministry of Public Health Collaboration (TUC) Chiang Rai Public Health Office Chiang Rai District Health Office Chiang Rai Municipal Health Office Chiang Rai Hospital |
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Information provided by: | Population Council |
ClinicalTrials.gov Identifier: | NCT00213031 |
The primary aims of the study were to assess the safety and acceptability of PC-515 when applied vaginally at least three times weekly for 12 months.
Secondary aims were to gather preliminary data on Carraguard’s effectiveness in preventing male-to-female transmission of HIV, and other STIs.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and 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 trial.
Condition | Intervention | Phase |
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HIV Infections Chlamydia Trachomatis Neisseria Gonorrhoeae Trichomonas Vaginitis Syphilis Herpes Simplex |
Drug: Carraguard (PC-515) |
Phase II |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Placebo-Controlled, Double-Blind Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of PC-515 (Lambda Carrageenan) for Vaginal Use as a Possible Microbicide |
Estimated Enrollment: | 165 |
Study Start Date: | February 2000 |
Estimated Study Completion Date: | December 2001 |
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) – including signs of local irritation, such as itching or burning; changes in vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings – when applied vaginally for 12 months; to evaluate acceptability; to assess feasibility of conducting a large scale microbicide trial in a non-sex worker population; to gauge women’s reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a Thai population.
Secondary aims were to investigate HIV infections averted (preliminary indications); other sexually transmitted infections averted – including C.
trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications); and effect on cervical cytology.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Thailand | |
Chiang Rai Health Club | |
Chiang Rai, Thailand, 57001 |
Principal Investigator: | Janneke HMM van de Wijgert, Ph.D. | Population Council |
Study ID Numbers: | Population Council #271, CDC & Prevention #2485 |
Study First Received: | September 13, 2005 |
Last Updated: | May 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00213031 History of Changes |
Health Authority: | United States: Food and Drug Administration; Thailand: Food and Drug Administration |
microbicides HIV prevention sexually transmitted infections female-initiated protection |
carrageenan expanded safety trial HIV Seronegativity HIV |
Bacterial Infections Sexually Transmitted Diseases, Viral Vaginitis Vaginal Diseases Gram-Negative Bacterial Infections Genital Diseases, Female Chlamydia Infections Parasitic Diseases Trichomonas Vaginitis Retroviridae Infections Syphilis Neisseriaceae Infections Herpes Simplex |
Protozoan Infections Skin Diseases Acquired Immunodeficiency Syndrome Trichomonas Infections Genital Diseases, Male Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Skin Diseases, Infectious HIV Infections Sexually Transmitted Diseases Gonorrhea DNA Virus Infections |
Bacterial Infections Anti-Infective Agents Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases, Viral Slow Virus Diseases Vaginitis Vaginal Diseases Mastigophora Infections Infection Gram-Negative Bacterial Infections Genital Diseases, Female Treponemal Infections Therapeutic Uses Parasitic Diseases Trichomonas Vaginitis |
Retroviridae Infections Syphilis Neisseriaceae Infections Herpes Simplex Protozoan Infections RNA Virus Infections Skin Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Trichomonas Infections Genital Diseases, Male Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Skin Diseases, Viral |