Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
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| ClinicalTrials.gov Identifier: NCT00213083 |
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Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : August 15, 2017
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Sponsor:
Population Council
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Population Council
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections AIDS Sexually Transmitted Diseases HIV Seroconversion | Drug: Carraguard (PC-515) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 6203 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Prevention |
| Official Title: | Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women |
| Study Start Date : | April 2004 |
| Actual Primary Completion Date : | April 2007 |
| Actual Study Completion Date : | April 2007 |
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
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| Ages Eligible for Study: | 16 Years to 40 Years (Child, Adult) |
| Sexes 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
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): 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 |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Population Council |
| ClinicalTrials.gov Identifier: | NCT00213083 |
| Other Study ID Numbers: |
Population Council #322 |
| First Posted: | September 21, 2005 Key Record Dates |
| Last Update Posted: | August 15, 2017 |
| Last Verified: | August 2017 |
Keywords provided by Population Council:
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Microbicide HIV AIDS STIs STDs Efficacy HSV Women |
South Africa seroconversion condom safe-sex vaginal intercourse prevention HIV Seronegativity |
Additional relevant MeSH terms:
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Sexually Transmitted Diseases HIV Seropositivity HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Infection |