Improvement in healing and reduction in HIV shedding with episodic acyclovir therapy as part of syndromic management among men: a randomized, controlled trial.
BACKGROUND
It 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.


METHODS
A 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.


RESULTS
A 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).


CONCLUSIONS
Addition of acyclovir to syndromic management will improve healing of genital ulcers and may potentially reduce HIV transmission in combination with other interventions.
Paz-Bailey
Gabriela
G
National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. gpaz@gt.cdc.gov
Sternberg
Maya
M
Puren
Adrian J
AJ
Markowitz
Lauri E
LE
Ballard
Ronald
R
Delany
Sinead
S
Hawkes
Sarah
S
Nwanyanwu
Okey
O
Ryan
Caroline
C
Lewis
David A
DA
D000212:Acyclovir / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006558:Herpes Genitalis / Q000188:drug therapy*; D018258:Herpesvirus 2, Human / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D013019:South Africa / Q000453:epidemiology; D014456:Ulcer / Q000188:drug therapy / Q000821:virology; D017201:Virus Shedding / Q000187:drug effects*; D055815:Young Adult
D000998:Antiviral Agents; D000212:Acyclovir