Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
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| ClinicalTrials.gov Identifier: NCT00213018 |
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Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : August 14, 2017
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Sponsor:
Population Council
Collaborators:
Bill and Melinda Gates Foundation
FHI 360
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)
Information provided by:
Population Council
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Brief Summary:
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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 400 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Prevention |
| 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 |
Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- 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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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Information from the National Library of Medicine
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
Locations
| South Africa | |
| University of Cape Town, Department of Community Health | |
| Cape Town, South Africa, 7925 | |
| Medical University of Southern Africa | |
| Soshanguve, South Africa, 0204 | |
Sponsors and Collaborators
Population Council
Bill and Melinda Gates Foundation
FHI 360
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)
Investigators
| Principal Investigator: | Charlotte E. Ellertson, MPA, Ph.D. | Population Council |
| ClinicalTrials.gov Identifier: | NCT00213018 |
| Other Study ID Numbers: |
Population Council #210 R01AI045468-02 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 21, 2005 Key Record Dates |
| Last Update Posted: | August 14, 2017 |
| Last Verified: | August 2017 |
Keywords provided by Population Council:
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microbicides HIV prevention sexually transmitted infections female-initiated protection |
carrageenan expanded safety trial HIV Seronegativity HIV |
Additional relevant MeSH terms:
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Gonorrhea Syphilis Trichomonas Vaginitis Vaginitis Infections Communicable Diseases Sexually Transmitted Diseases Genital Diseases Urogenital Diseases Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Sexually Transmitted Diseases, Bacterial Neisseriaceae Infections Vaginal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Treponemal Infections Spirochaetales Infections Trichomonas Infections Protozoan Infections Parasitic Diseases |