Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
This study has been completed.
Sponsor:
Population Council
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Population Council
ClinicalTrials.gov Identifier:
NCT00213083
First received: September 13, 2005
Last updated: May 14, 2012
Last verified: May 2012
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Purpose
The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections AIDS Sexually Transmitted Diseases HIV Seroconversion |
Drug: Carraguard (PC-515) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women |
Resource links provided by NLM:
Further study details as provided by Population Council:
Primary Outcome Measures:
- Time to HIV seroconversion during trial participation (evaluated quarterly)
Secondary Outcome Measures:
- Determine long-term safety based on the incidence of sexually transmitted infections (STI), Chlamydia, gonorrhoeae, trichomoniasis, and syphilis tests and the number of adverse events and serious adverse events
- Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated
| Estimated Enrollment: | 6203 |
| Study Start Date: | April 2004 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
This study is designed to show if Carraguard® can protect women against HIV if it is used before sex, and is safe for long-term use.
Eligibility| Ages Eligible for Study: | 16 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- HIV negative and agree to be tested for HIV and told their results at all visits during the study
- Aged 16 - 40 years of age
- Have had at least one vaginal intercourse within the last three months
- Willing and able to give written informed consent (or if desired, consent provided by parent or guardian with written assent from the minor participant)
- Provide locator information to study staff throughout the trial
- Comply with all aspects of the study protocol, including random assignment to the Carraguard® plus condom or placebo plus condom arm, clinical valuations, specimen collection and testing, visit schedule and study drug regimen
- Citizen or permanent resident of South Africa
- Resident for the past year and intends to reside in the catchment area of the site for the next two years
- During the study, will not use any vaginal products except tampons or those prescribed or approved by the study clinician.
Exclusion Criteria:
- Currently pregnant, or indicate a desire to become pregnant in the next two years at the time of screening
- Within four weeks of last pregnancy outcome at the time of enrolment
- Pap smear at screening is graded as carcinoma.
- Injected illicit drugs in the 12 months prior to screening
- Participating in any other clinical trial/HIV prevention study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213083
Locations
| South Africa | |
| Isipingo Clinic | |
| Overport, Durban, South Africa, 4067 | |
| Empilisweni Clinic | |
| Cape Town, South Africa, 7925 | |
| Setshaba Research Clinic, University of Limpopo - Medunsa Campus | |
| Medunsa, South Africa, 0204 | |
Sponsors and Collaborators
Population Council
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Investigators
| Principal Investigator: | Pekka Lahteenmaki, MD, PhD | Population Council, Center for Biomedical Research |
More Information
Additional Information:
Publications:
DeKock A, Skoler S, Ahmed K, Govender S. Response to enrolling adolescents in research on HIV and other sensitive issues: Lessons from South Africa. Public Library of Science Medicine 3(7), 2006.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Population Council |
| ClinicalTrials.gov Identifier: | NCT00213083 History of Changes |
| Other Study ID Numbers: | Population Council #322 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 14, 2012 |
| Health Authority: | South Africa: Medicines Control Council United States: Food and Drug Administration |
Keywords provided by Population Council:
|
Microbicide HIV AIDS STIs STDs Efficacy HSV Women |
South Africa seroconversion condom safe-sex vaginal intercourse prevention HIV Seronegativity |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections HIV Seropositivity Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Infection Genital Diseases, Male Genital Diseases, Female Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013
