- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213018
Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
A Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Cape Town, South Africa, 7925
- University of Cape Town, Department of Community Health
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Soshanguve, South Africa, 0204
- Medical University of Southern Africa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Compliance: collection of applicators and interview(monthly)
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Acceptability: interview (quarterly)
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Safety (toxicity): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal flora;
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Secondary Outcome Measures
Outcome Measure |
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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).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charlotte E. Ellertson, MPA, Ph.D., Population Council
Study record dates
Study Major Dates
Study Start (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Parasitic Diseases
- Protozoan Infections
- Vaginal Diseases
- Neisseriaceae Infections
- Sexually Transmitted Diseases, Bacterial
- Spirochaetales Infections
- Treponemal Infections
- Trichomonas Infections
- Vaginitis
- Gonorrhea
- Syphilis
- Trichomonas Vaginitis
Other Study ID Numbers
- Population Council #210
- R01AI045468-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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