Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission - Full Text View

Sponsor:	Population Council
Collaborators:	United States Agency for International Development (USAID) Bill and Melinda Gates Foundation
Information provided by:	Population Council
ClinicalTrials.gov Identifier:	NCT00213083

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: AIDS Sexually Transmitted Diseases

U.S. FDA Resources

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:	March 2004
Estimated Study Completion Date:	March 2007

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
Empilisweni Clinic
Cape Town, South Africa, 7925
Setshaba Research Clinic, University of Limpopo - Medunsa Campus
Medunsa, South Africa, 0204
South Africa, Durban
Isipingo Clinic
Overport, Durban, South Africa, 4067

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:

Official website of the Population Council This link exits the ClinicalTrials.gov site

Publications:

Skoler S, Govender S, Altini L, Ahmed K, Waldron D, Myer L, Lahteenmaki P. Risks in the use of an unblinded-control group. J Infect Dis. 2005 Apr 15;191(8):1378-9; author reply 1379-80. No abstract available.

Wallace AR, Teitelbaum A, Wan L, Mulima MG, Guichard L, Skiler S, Vilakazi H, Mapula FS, Rossier J, Govender SN, Lahteenmaki P, Maguire RA, Phillips DM. Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials. Contraception. 2007 Jul;76(1):53-6. Epub 2007 May 11.

DeKock A, Skoler S, Ahmed K, Govender S. Response to enrolling adolescents in research on HIV and other sensitive issues: Lessons from South Africa. Public Library of Science Medicine 3(7), 2006.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Skoler-Karpoff S, Ramjee G, Ahmed K, Altini L, Plagianos MG, Friedland B, Govender S, De Kock A, Cassim N, Palanee T, Dozier G, Maguire R, Lahteenmaki P. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Dec 6;372(9654):1977-87.

Study ID Numbers:	Population Council #322
Study First Received:	September 13, 2005
Last Updated:	August 7, 2007
ClinicalTrials.gov Identifier:	NCT00213083 History of Changes
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:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Genital Diseases, Male
Infection
Pharmacologic Actions

Immunologic Deficiency Syndromes
Genital Diseases, Female
Virus Diseases
HIV Seropositivity
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010