Objective By a randomised, double-blind, placebo-controlled trial of aciclovir 800 mg twice daily for 5 days added to the syndromic management of genital ulcer disease (GUD) to determine the impact on ulcer healing and HIV outcomes.
Methods Patients presenting with GUD in Malawi were evaluated for HIV and herpes simplex virus type-2 (HSV-2) serologies, ulcer aetiology, lesional, genital and plasma HIV-1 RNA and CD4+ count. Patients were followed up at days 2, 4, 7, 14 and 28. The primary study outcome was ulcer healing at day 14, with secondary outcomes being lesional and genital HIV-1 shedding at day 14 and HIV-1 plasma viral load at day 28 among HIV-1/HSV-2 co-infected individuals.
Results Four hundred and twenty-two patients (74% male) were randomised (208 to aciclovir, 214 to placebo), of whom 61% were HIV-1 seropositive and 72% HSV-2 seropositive; 67% (267/398) had HSV-2 ulcers. 85% of ulcers were healed at day 14 with no difference between treatment arms (risk ratio (RR)=1.02, 95% CI 0.93 to 1.11). Among 244 HIV-1/HSV-2 co-infected individuals, aciclovir reduced lesional HIV-1 RNA (adjusted RR=0.64, 95% CI 0.41 to 0.99) and seminal HIV-1 RNA (adjusted RR=0.59, 95% CI 0.40 to 0.88), but not cervical HIV-1 RNA or plasma HIV-1 RNA.
Conclusions Episodic HSV treatment with aciclovir added to syndromic management did not produce a significant clinical benefit in this African population.
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This work was presented as an oral presentation at the XVII International AIDS Conference, Mexico City, Mexico, 3–8 August 2008: Phiri S, Hoffman I, Weiss HA, et al. Impact of aciclovir on ulcer healing and HIV-1 lesional and genital shedding among patients with genital ulcer disease in Malawi: a randomised controlled trial. (Oral THAC0303).
Funding The study was funded by the UK Department for International Development (DFID) through the Malawi National AIDS Commission, and by grants from the University of North Carolina at Chapel Hill, NC, USA. The views expressed are those of the authors and cannot be taken to reflect the official opinions of DFID, or of the US Centers for Disease Control and Prevention (CDC).
Competing interests None.
Patient consent Obtained.
Provenance and peer review Not commissioned; not externally peer reviewed.
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