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The Effect of Suppressive Acyclovir Therapy on HIV Cervicovaginal Shedding in HIV- and HSV-2-infected Women, Chiang Rai, Thailand
Eileen Dunne*1, S Whitehead1,2, S Whitehead1,2, M Sternberg1, S Thep-Amnuay2, W Leelawiwat2, J McNicholl1,2, J McNicholl1,2, S Sumanapun3, J Tappero1,2, J Tappero1,2, T Siriprapasiri4, and L Markowitz1
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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