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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
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
The Lancet, Volume 375, No. 9717, Year 2010
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Description
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 4·1 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 [HR] 0·84, 95% CI 0·71-0·98, p=0·03). In those with CD4 counts ≥350 cells per μL, aciclovir delayed risk of CD4 cell counts falling to <350 cells per μL by 19% (0·81, 0·71-0·93, p=0·002). 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. © 2010 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Lingappa, Jairam R.
Unknown Affiliation
Baeten, Jared M.
Unknown Affiliation
Wald, Anna
Unknown Affiliation
Hughes, James P.
Unknown Affiliation
Thomas, Katherine K.
Unknown Affiliation
Mujugira, Andrew
Unknown Affiliation
Mugo, Nelly Rwamba
Unknown Affiliation
Bukusi, Elizabeth Anne
Unknown Affiliation
Cohen, Craig R.
Unknown Affiliation
Katabira, Elly Tebasoboke
Unknown Affiliation
Ronald, Allan R.
Unknown Affiliation
Kiarie, James Njogu
Unknown Affiliation
Farquhar, Carey
Unknown Affiliation
Stewart, Grace John
Unknown Affiliation
Makhema, Joseph M.
Unknown Affiliation
Essex, Myron E.
Unknown Affiliation
Were, Edwin O.
Unknown Affiliation
Fife, Kenneth H.
Unknown Affiliation
De Bruyn, Guy
Unknown Affiliation
Gray, Glenda E.
Unknown Affiliation
McIntyre, James Alasdair
Unknown Affiliation
Manongi, Rachel N.
Unknown Affiliation
Kapiga, Saidi Hussein
Unknown Affiliation
Coetzee, David John
Unknown Affiliation
Allen, Susan A.
Unknown Affiliation
Inambao, Mubiana
Unknown Affiliation
Kayitenkore, Kayitesi
Unknown Affiliation
Karita, Etienne
Unknown Affiliation
Kanweka, William
Unknown Affiliation
Delany-Moretlwe, Sinead
Unknown Affiliation
Rees, Helen V.
Unknown Affiliation
Vwalika, Bellington
Unknown Affiliation
Magaret, Amalia Meier
Unknown Affiliation
Wang, Richard S.
Unknown Affiliation
Kidoguchi, Lara
Unknown Affiliation
Barnes, Linda S.
Unknown Affiliation
Ridzon, Renée
Unknown Affiliation
Corey, Lawrence
Unknown Affiliation
Celum, Connie L.
Unknown Affiliation
Statistics
Citations: 135
Authors: 39
Affiliations: 21
Identifiers
Doi:
10.1016/S0140-6736(09)62038-9
ISSN:
01406736
Research Areas
Environmental
Infectious Diseases
Study Design
Exploratory Study
Study Locations
Multi-countries