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Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00213083
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 15, 2017
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Population Council

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

Detailed Description:
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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Time to HIV seroconversion during trial participation (evaluated quarterly)

Secondary Outcome Measures :
  1. 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
  2. Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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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
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Principal Investigator: Pekka Lahteenmaki, MD, PhD Population Council, Center for Biomedical Research
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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:
South Africa
vaginal intercourse
HIV Seronegativity
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
HIV Seropositivity
HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes