Clinical trial NCT00213083: Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
Official title: Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Population Council
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Bill and Melinda Gates Foundation
First posted: 2005-09-21
Enrollment: 6203
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Time to HIV seroconversion during trial participation (evaluated quarterly)
Secondary outcomes:
measure: 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
measure: Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated
Other outcomes:
Locations:
city: Overport
country: South Africa
facility: Isipingo Clinic
state: Durban
city: Cape Town
country: South Africa
facility: Empilisweni Clinic
city: Medunsa
country: South Africa
facility: Setshaba Research Clinic, University of Limpopo - Medunsa Campus
Study officials:
affiliation: Population Council, Center for Biomedical Research
name: Pekka Lahteenmaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1086/427833. No abstract available.
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. doi: 10.1016/j.contraception.2006.10.012. Epub 2007 May 11.
citation: 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.
citation: 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.