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
  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)
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.

  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:
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 April 15, 2014