14th Conference on Retroviruses and Opportunistic Infections Los Angeles, California - February 25-28, 2007

Conf Retrovir Opportunistic Infect 2007 Feb 25-28;14: (abstract no. 30)

Eileen Dunne¹, S Whitehead^1,2, M Sternberg¹, S Thep-Amnuay², W Leelawiwat², J McNicholl^1,2, S Sumanapun³, J Tappero^1,2, T Siriprapasiri⁴, and L Markowitz^1
1CDC, Atlanta, GA, US; ²Thailand Ministry of Publ Hlth-CDC Collaboration, Nonthaburi and Chiang Rai Provincial Publ Hlth Office; ³Chiang Rai Provincial Publ Hlth Office, Thailand; and ⁴Ministry of Publ Hlth, Nonthaburi, Thailand

BACKGROUND: HSV-2 infection is associated with increased risk for HIV acquisition, but little is known about the effect of herpes simplex virus (HSV) or HSV suppressive therapy on HIV genital shedding. We conducted a randomized controlled clinical trial to assess the effect of suppressive acyclovir therapy on HIV genital shedding among HIV/HSV-2-co-infected women.

METHODS: HIV/HSV-2-co-infected women ages 18 to 49 years with CD4 counts >200 cells/µL and who were not receiving ART were enrolled in a randomized, placebo-controlled, double-blind cross-over trial lasting 3 months. Women received either acyclovir (800 mg twice daily) or placebo for 1 month, followed by a washout month with no product; in the third month they crossed over to acyclovir or placebo. Cervicovaginal lavage (CVL) specimens were obtained from enrolled women at baseline and at weekly visits for 3 months. CVL specimens were separated into supernatants and pellets, and frozen. HIV-1 was detected and quantified using the Amplicor Version 1.5 assay. For each woman, the median HIV CVL viral load of 3 weekly measurements was identified for each study month, and the mean of the monthly medians was compared for treatment A and treatment B using a paired Prentice-Wilcoxon test.

RESULTS: We enrolled 67 women in the trial; the median age of participants was 33 years (range 22 to 46 years). At baseline, median CD4 count was 366 (209 to 930) cells/µL, median HIV-1 plasma viral load was 4.6 (2.9 to 5.7) log copies/mL, and median CVL HIV viral load was 1.8 (0 to 4.1) log copies/mL. Overall, 75% of women had detectable CVL HIV at baseline. The mean CVL HIV viral load was 1.15 (SD 1.31) log copies/mL during the month of treatment A and 1.72 (SD 1.24) log copies/mL during the month of treatment B (p <0.001).

CONCLUSIONS: Most women co-infected with HIV and HSV-2 had detectable HIV genital shedding at baseline. There was a significant difference in CVL HIV between the 2 treatment groups, suggesting a treatment effect. The study will be unblinded when all primary analyses are complete.

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2007-02-25
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