Impact of aciclovir on ulcer healing, lesional, genital and plasma HIV-1 RNA among patients with genital ulcer disease in Malawi. Issue 5 (5th May 2010)

• Record Type: Journal Article
• Authors: Phiri, Sam; Hoffman, Irving F; Weiss, Helen A; Martinson, Francis; Nyirenda, Naomi; Kamwendo, Debbie; Fiscus, Susan A; Chen, Cheng-Yen; Miller, William C; van der Hoeven, Len; Chilongozi, David; Cohen, Myron S; Mayaud, Philippe
• Is Part Of: Sexually transmitted infections. Volume 86:Issue 5(2010)
• Page Start: 345
• Page End: 352
• Publication Date: 2010-05-05
• Subjects: Aciclovir -- genital herpes -- genital ulcers -- trials -- Africa; Sexually transmitted diseases -- Periodicals; HIV infections -- Periodicals; 616.951005
• DOI: 10.1136/sti.2009.041814
• Languages: English
• ISSNs: 1368-4973

Abstract

Abstract : 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.