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HIV genital shedding and safety of Carraguard use by HIV-infected women: a crossover trial in Thailand

McLean, Catherine Aa,*; van de Wijgert, Janneke HHMb,c,*; Jones, Heidi Eb,d; Karon, John Me; McNicoll, Janet Ma,f; Whitehead, Sara Ja,f; Braunstein, Sarahb,d; Achalapong, Jullapongg; Chaikummao, Supapornf; Tappero, Jordan Wa,f; Markowitz, Lauri Ea; Kilmarx, Peter Ha

doi: 10.1097/QAD.0b013e328333bf89
Clinical Science: Concise Communications

Objective: To evaluate the safety, including impact on genital HIV RNA shedding, of Carraguard vaginal gel in HIV-infected women.

Design: This is a randomized, controlled, crossover study of Carraguard in HIV-infected women in Thailand.

Methods: Each woman (CD4+ cell count 51–500 cells/μl and not on antiretroviral therapy) used each treatment (Carraguard, methylcellulose placebo, and no-product) once daily for 7 days during each 1-month period (3-week wash-out). Women were randomized to one of the six possible treatment sequences. Safety assessments were conducted at baseline (pregel), 15 min postgel, day 7, and day 14, and included HIV RNA measurements in cervicovaginal lavage (CVL) specimens.

Results: Sixty women were enrolled, and 99% of scheduled study visits were completed. At baseline, median age (34 years), CD4+ lymphocyte count (296 cells/μl), plasma HIV viral load (4.6 log10 copies/ml), CVL HIV viral load (3.1 log10 total copies per CVL), and sexual behaviors were similar among randomization groups. HIV viral load, leukocyte and hemoglobin levels, and epithelial cell counts in CVLs were lower 15 min after application of Carraguard or placebo compared with no product; CVL HIV viral load was still lower at day 7 but returned to baseline by day 14. Carraguard use was not associated with prevalent or incident genital findings or abnormal vaginal flora.

Conclusion: Carraguard appears to be well tolerated for once-daily vaginal use by HIV-infected women. The observed reduction in CVL HIV viral load in the gel months may be clinically relevant but could have resulted from interference with sample collection by study gels.

aNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

bPopulation Council, New York, New York, USA

cAcademic Medical Center, Amsterdam, The Netherlands

dColumbia University Medical Center, New York, New York, USA

eEmergint Corp, Louisville, Kentucky, USA

fThailand Ministry of Public Health – U.S. CDC Collaboration, Bangkok

gChiang Rai Hospital, Chiang Rai, Thailand.

*C.A.M. and J.H.H.M.vdW. contributed equally to the writing of this article.

Received 6 February, 2009

Revised 30 September, 2009

Accepted 1 October, 2009

Correspondence to Peter H. Kilmarx, MD, Centers for Disease Control and Prevention, 1600 Clifton Road, MS E-45, Atlanta, GA 30030, USA. Tel: +1 404 324 7471; e-mail: pbk4@cdc.gov

© 2010 Lippincott Williams & Wilkins, Inc.