Improvement in Healing and Reduction in HIV Shedding with Episodic Acyclovir Therapy as Part of Syndromic Management among Men: A Randomized, Controlled Trial

BackgroundIt is uncertain whether episodic acyclovir will enhance ulcer healing if delivered at primary health care settings, because there is often a delay in treatment initiation MethodsA double-blind, randomized, placebo-controlled trial of 5-day acyclovir (400 mg 3 times daily) was conducted amo...

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Published in:	The Journal of infectious diseases 2009-10, Vol.200 (7), p.1039-1049
Main Authors:	Paz-Bailey, Gabriela, Sternberg, Maya, Puren, Adrian J., Markowitz, Lauri E., Ballard, Ronald, Delany, Sinead, Hawkes, Sarah, Nwanyanwu, Okey, Ryan, Caroline, Lewis, David A.
Format:	Article
Language:	eng
Subjects:	Acyclovir - therapeutic use Adolescent Adult AIDS Antiviral Agents - therapeutic use Biological and medical sciences Double-Blind Method Fundamental and applied biological sciences. Psychology Genitalia Healing Herpes Genitalis - drug therapy Herpes simplex virus 2 Herpesvirus 2, Human - drug effects HIV HIV 1 HIV Infections - drug therapy HIV Infections - prevention & control HIV Infections - virology HIV-1 - drug effects HIV-1 - genetics HIV/AIDS Human herpesvirus 2 Human immunodeficiency virus 1 Human immunodeficiency virus 2 Humans Infections Infectious diseases Male Medical sciences Microbiology Middle Aged Miscellaneous Placebos RNA South Africa - epidemiology Treponema pallidum Ulcer - drug therapy Ulcer - virology Ulcers Virology Virus Shedding - drug effects Young Adult
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Summary:	BackgroundIt is uncertain whether episodic acyclovir will enhance ulcer healing if delivered at primary health care settings, because there is often a delay in treatment initiation MethodsA double-blind, randomized, placebo-controlled trial of 5-day acyclovir (400 mg 3 times daily) was conducted among men with genital ulcers in South Africa. Participants received syndromic management; were tested for ulcer etiology, human immunodeficiency virus (HIV), syphilis, and herpes simplex virus type 2 (HSV-2); and were seen over the course of a month to evaluate ulcer healing and HIV-1 RNA shedding. Outcomes were ulcer duration and HIV-1 RNA shedding, assessed on day 7 among HIV-1–seropositive participants with a herpetic ulcer ResultsA total of 309 men received acyclovir, and 306 received placebo; 63% were HIV-1 positive. There were 295 HIV-1–positive participants with a herpetic ulcer. Acyclovir improved ulcer healing—61% of those receiving acyclovir healed by day 7, compared with 42% of those receiving placebo (adjusted relative risk, 1.4 [95% confidence interval, 1.1–1.8]; P=.003). Acyclovir also improved healing by a median of 3 days (P=.002) and reduced HIV-1 ulcer shedding on day 7 (24% for acyclovir vs 37% for placebo; P=.05) ConclusionsAddition of acyclovir to syndromic management will improve healing of genital ulcers and may potentially reduce HIV transmission in combination with other interventions Trial registrationClinicalTrials.gov identifier: NCT00164424
ISSN:	0022-1899 1537-6613