Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
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|ClinicalTrials.gov Identifier: NCT00213018|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 14, 2017
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 or disease||Intervention/treatment||Phase|
|HIV Infections Chlamydia Trachomatis Neisseria Gonorrhoeae Trichomonas Vaginitis Syphilis||Drug: Carraguard (PC-515)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission|
|Actual Study Start Date :||October 1999|
|Actual Study Completion Date :||January 2002|
- Safety (toxicity): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal flora;
- Compliance: collection of applicators and interview(monthly)
- Acceptability: interview (quarterly)
- Preliminary effectiveness: Swabs taken to test for sexually transmitted infections - gonorrhea, chlamydia, trichomoniasis (monthly) and blood drawn for syphilis and HIV testing (Month 1 and quarterly thereafter).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213018
|University of Cape Town, Department of Community Health|
|Cape Town, South Africa, 7925|
|Medical University of Southern Africa|
|Soshanguve, South Africa, 0204|
|Principal Investigator:||Charlotte E. Ellertson, MPA, Ph.D.||Population Council|