Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

HIV Infections Clinical Trial

Official title:

Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213083
• Other study ID #: Population Council #322
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: August 11, 2017
• Start date: April 2004
• Est. completion date: April 2007

Study information

• Verified date: August 2017
• Source: Population Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6203
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• HIV Infections
• HIV Seroconversion
• HIV Seropositivity
• Sexually Transmitted Diseases

Intervention

Drug:
• Carraguard (PC-515)

Locations

Country	Name	City	State
South Africa	Empilisweni Clinic	Cape Town
South Africa	Setshaba Research Clinic, University of Limpopo - Medunsa Campus	Medunsa
South Africa	Isipingo Clinic	Overport	Durban

Sponsors (3)

Lead Sponsor	Collaborator
Population Council	Bill and Melinda Gates Foundation, United States Agency for International Development (USAID)

Country where clinical trial is conducted

South Africa, 

References & Publications (3)

Singh JA, Karim SS, Karim QA, Mlisana K, Williamson C, Gray C, Govender M, Gray A. Enrolling adolescents in research on HIV and other sensitive issues: lessons from South Africa. PLoS Med. 2006 Jul;3(7):e180. Epub 2006 Apr 18. — View Citation

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. — View Citation

Wallace AR, Teitelbaum A, Wan L, Mulima MG, Guichard L, Skoler 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. Erratum in: Contraception. 2007 Oct;76(4):335. Skiler, Stephanie [corrected to Skoler, Stephanie]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to HIV seroconversion during trial participation (evaluated quarterly)
Secondary	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
Secondary	Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated

External Links

•   Official website of the Population Council