The effect of anti-herpetic suppressive therapy on HIV shedding in South African women who are seropositive for HIV and HSV2: a randomised controlled trial
HIV/AIDS: HIV prevention; STIs; Herpes Simplex Virus type II (HSV2); genital herpes
Esselen Street Clinic, Hillbrow, Johannesburg
Duration of Project
Formative research phase August 2003 - December Dec 2004
Trial Dec 2004 - Dec 2006
Contract Laboratory Services (CLS), London School of Hygiene & Tropical Medicine (LSHTM), IINSERM U430, Paris
Wellcome Trust, UK; DFID Knowledge Programme on STIs/HIV/AIDS; DFID Research Programme Consortium for Reproductive Health and HIV; National Research Foundation (South Africa).
Dr Sinead Delany-Moretlwe and Dr Nkuli Mlaba
Project Aims /Objectives
This study is a randomised placebo controlled trial involving 300 HSV-2 seropositive HIV seropositive women who do not require Highly Active Antiretroviral therapy in South Africa.
The trial aims to determine whether twice daily suppressive therapy with acyclovir can reduce the frequency and quantity of HIV viral shedding in the genital tract (a marker of HIV transmission potential).
Secondary objectives include determining the effect of twice-daily acyclovir treatment on plasma viral load (HIV didease progression), and on the frequency and quantity of HSV-2 shedding in the genital tract. We will also investigate adherence to twice daily treatment in this population.
A comprehensive formative research phase was undertaken to identify a highly sensitive and specific HSV-2 serologic testing algorithm for use in an HIV positive population. Research was also conducted to determine factors which might influence adherence to daily treatment with acyclovir. A pilot study was undertaken to compare methods four methods for genital specimen collection, to test planned trial procedures, and to evaluate HIV-1 RNA and HSV-2 DNA assays for evaluation of genital secretions in a South African population.
Recruitment began in April 2005 and was completed in April 2006. Over 589 women were counseled and tested for HIV and HSV-2. Three hundred eligible participants were enrolled in the trial.
Enrolled participants were randomised to receive either 400mg acyclovir or matching placebo. Each participant was followed up for a period of 3 months. Participants are seen on a monthly basis for interview, genital shedding measurements, risk reduction conseling, dispensing of study drug and condoms. All participants receive free condoms, STI treatment, treatment for genital herpes episodes, health education and referral to HIV treatment services during the study.
The last participant exited the study in July 2007.
The results of this trial are expected in 2008
It is hoped that the study will provide evidence for whether daily treatment for genital herpes can reduce HIV genital viral load (a marker of HIV transmission) and perhaps, prevent HIV disease progression.
- Contribution to VCT and referral of HIV positive women to HIV treatment services in the City of Johannesburg;
- Contribution to WHO guidelines of the use of acyclovir for care of HIV+ individuals;
- Additional research will be conducted to explore factors associated with treatment adherence during the trial;
- University of the Witwatersrand Masters in Public Health research project on factors associated with HSV-2 infection and symptom recognition based on data collected during formative research
Dissemination of research results
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