Clinical Trials


Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

This study has been completed
Population Council

United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation

Information provided by (Responsible Party)
Population Council Identifier

First received: September 13, 2005
Last updated: August 11, 2017
Last Verified: August 2017
History of Changes


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
Sexually Transmitted Diseases
HIV Seroconversion

Drug : Carraguard (PC-515)
Phase 3

Study Type: Interventional
Study Design: 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

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

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)

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.



Ages Eligible for Study: 16 Years to 40 Years  
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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00213083


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


Principal Investigator: Pekka Lahteenmaki, MD, PhD Population Council, Center for Biomedical Research
More Information

More Information

Additional Information:

Official website of the Population Council

Responsible Party: Population Council Identifier: NCT00213083   History of Changes  
Other Study ID Numbers: Population Council #322  
Study First Received: September 13, 2005  
Last Updated: August 11, 2017  

Keywords provided by Population Council:

South Africa
vaginal intercourse
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Sexually Transmitted Diseases
HIV Seropositivity
Anti-Infective Agents processed this data on July 20, 2018
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