And here's the Summary from the Lancet
The Lancet, Early Online Publication, 15 February 2010doi:10.1016/S0140-6736(09)62038-9Cite or Link Using DOI
Daily aciclovir for HIV-1 disease progression in people dually infected with HIV-1 and herpes simplex virus type 2: a randomised placebo-controlled trial
Original TextDr Jairam R Lingappa MD a b c , Jared M Baeten MD a b, Anna Wald MD b d f g, James P Hughes PhD e, Katherine K Thomas MS b, Andrew Mujugira MBChB a, Nelly Mugo MBChB a h, Elizabeth A Bukusi MBChB a h i, Craig R Cohen MD j, Elly Katabira MBChB k, Allan Ronald MD l, James Kiarie MBChB h, Carey Farquhar MD b d, Grace John Stewart MD b d, Joseph Makhema MBChB m, Myron Essex DVM n, Edwin Were MBChB o, Kenneth H Fife MD p, Guy de Bruyn MBBCh q, Glenda E Gray MBBCh q, James A McIntyre FRCOG q, Rachel Manongi MD s, Saidi Kapiga MD t, David Coetzee MBBCh u, Susan Allen MD v w, Mubiana Inambao MBChB v w, Kayitesi Kayitenkore MD v w, Etienne Karita MD v w, William Kanweka MD v w, Sinead Delany MD r, Helen Rees MBBChir r, Bellington Vwalika MD v w, Amalia S Magaret PhD f g, Richard S Wang MS a, Lara Kidoguchi MPH a, Linda Barnes MHA a, Renee Ridzon MD x, Lawrence Corey MD b f g, Connie Celum MD a b d, for the Partners in Prevention HSV/HIV Transmission Study Team
Summary
Background
Most people infected with HIV-1 are dually infected with herpes simplex virus type 2. Daily suppression of this herpes virus reduces plasma HIV-1 concentrations, but whether it delays HIV-1 disease progression is unknown. We investigated the effect of aciclovir on HIV-1 progression.
Methods
In a trial with 14 sites in southern Africa and east Africa, 3381 heterosexual people who were dually infected with herpes simplex virus type 2 and HIV-1 were randomly assigned in a 1:1 ratio to aciclovir 400 mg orally twice daily or placebo, and were followed up for up to 24 months. Eligible participants had CD4 cell counts of 250 cells per μL or higher and were not taking antiretroviral therapy. We used block randomisation, and patients and investigators were masked to treatment allocation. Effect of aciclovir on HIV-1 disease progression was defined by a primary composite endpoint of first occurrence of CD4 cell counts of fewer than 200 cells per μL, antiretroviral therapy initiation, or non-trauma related death. As an exploratory analysis, we assessed the endpoint of CD4 falling to <350 cells per μL. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00194519.
Findings
At enrolment, the median CD4 cell count was 462 cells per μL and median HIV-1 plasma RNA was 41 log10 copies per μL. Aciclovir reduced risk of HIV-1 disease progression by 16%; 284 participants assigned aciclovir versus 324 assigned placebo reached the primary endpoint (hazard ratio
084, 95% CI 071098, p=003). In those with CD4 counts ≥350 cells per μL, aciclovir delayed risk of CD4 cell counts falling to <350 cells per μL by 19% (081, 071093, p=0002)
Interpretation
The role of suppression of herpes simplex virus type 2 in reduction of HIV-1 disease progression before initiation of antiretroviral therapy warrants consideration.
Funding
Bill & Melinda Gates Foundation.
