drugset / Trial / NCT00213044
A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women
Phase 1
Completed
60 enrolled
Population Council
Centers for Disease Control and Prevention · collabChiang Rai District Health Office · collabChiang Rai Hospital · collabChiang Rai Municipal Health Office · collabChiang Rai Public Health Office · collabMinistry of Health, Thailand · collabNational Center for HIV STD and TB Prevention · collabNational Center for Infectious Diseases · collab
RandomizedCrossoverDouble-blindPrevention
Summary
Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited from general medical clinics, family planning clinics, groups/organizations working with persons living with AIDS to assess product safety, effect on genital tract HIV shedding, and product acceptability with vaginal use of Carraguard gel among HIV-infected women. Women had to be abstinent or in a seroconcordant relationship with only one partner for the study period.
Timeline
- Start
- 2003-03
- Primary completion
- —
- Completion
- 2004-06
Publications
- Whitehead SJ, McLean C, Chaikummao S, Braunstein S, Utaivoravit W, van de Wijgert JH, Mock PA, Siraprapasiri T, Friedland BA, Kilmarx PH, Markowitz LE. Acceptability of Carraguard vaginal microbicide gel among HIV-infected women in Chiang Rai, Thailand. PLoS One. 2011;6(9):e14831. doi: 10.1371/journal.pone.0014831. Epub 2011 Sep 7.
- McLean CA, van de Wijgert JH, Jones HE, Karon JM, McNicoll JM, Whitehead SJ, Braunstein S, Achalapong J, Chaikummao S, Tappero JW, Markowitz LE, Kilmarx PH. HIV genital shedding and safety of Carraguard use by HIV-infected women: a crossover trial in Thailand. AIDS. 2010 Mar 13;24(5):717-22. doi: 10.1097/QAD.0b013e328333bf89.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carraguard | Other / unclassified | — | Other |