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Trial record 1 of 3 for:    phase 3 carraguard
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Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

This study has been completed.
Sponsor:
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

September 13, 2005
May 14, 2012
April 2004
April 2007   (final data collection date for primary outcome measure)
Time to HIV seroconversion during trial participation (evaluated quarterly)
Time to HIV seroconversion during trial participation (evaluated quarterly).
Complete list of historical versions of study NCT00213083 on ClinicalTrials.gov Archive Site
  • 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
Determine long term safety based on genital ulcer disease (evaluated through pelvic exam at all visits), and STI infection. Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated.
Not Provided
Not Provided
 
Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • AIDS
  • Sexually Transmitted Diseases
  • HIV Seroconversion
Drug: Carraguard (PC-515)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6203
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Female
16 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00213083
Population Council #322
Not Provided
Population Council
Population Council
  • United States Agency for International Development (USAID)
  • Bill and Melinda Gates Foundation
Principal Investigator: Pekka Lahteenmaki, MD, PhD Population Council, Center for Biomedical Research
Population Council
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP