Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

NCT00213083 | Completed Phase 3

• 1 other identifier: Population Council #322
• Study Type: interventional
• Target: 6,203
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infections; AIDS; Sexually Transmitted Diseases; HIV Seroconversion

Keywords

Microbicide; HIV; AIDS; STIs; STDs; Efficacy; HSV; Women; South Africa; seroconversion; condom; safe-sex; vaginal intercourse; prevention; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Time to HIV seroconversion during trial participation (evaluated quarterly)

Secondary Outcomes (2)

• 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

Interventions

Carraguard (PC-515) DRUG

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Council: lead
• United States Agency for International Development (USAID): collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (3)

Isipingo Clinic

Overport, Durban, 4067, South Africa

Location

Empilisweni Clinic

Cape Town, 7925, South Africa

Location

Setshaba Research Clinic, University of Limpopo - Medunsa Campus

Medunsa, 0204, South Africa

Location

Related Publications (4)

• 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. doi: 10.1086/427833. No abstract available.

  PMID: 15776387 BACKGROUND

• 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. doi: 10.1016/j.contraception.2006.10.012. Epub 2007 May 11.

  PMID: 17586138 BACKGROUND

• 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. doi: 10.1371/journal.pmed.0030180. Epub 2006 Apr 18.

  PMID: 16608384 BACKGROUND

• 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. doi: 10.1016/S0140-6736(08)61842-5.

  PMID: 19059048 DERIVED

Related Links

• Official website of the Population Council

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; HIV Seropositivity; Safe Sex; Coitus

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Study Officials

• Pekka Lahteenmaki, MD, PhD

  Population Council, Center for Biomedical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

ZA (3)