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: firstname.lastname@example.org