HPTN039: A phase III randomized, double blind, placebo controlled trial of acyclovir for the reduction of HIV acquisition among high risk HSV2+ HIV- individuals
HIV/AIDS; STIs; Herpes Simplex Virus type II (HSV2), genital herpes; HIV prevention.
Esselen Street Clinic, Hillbrow, Johannesburg
Duration of Project
2004 – 2008
University of Washington, HIV Prevention Trials Network (HPTN)
Division of AIDS, US National Institutes of Health (NIH) and University of Washington
Dr Nonkululeko Mlaba and Dr Sinead Delany-Moretlwe
Project Aims /Objectives
This study is a protocol of the HIV Prevention Trials Network and is a multi-centre randomised placebo controlled trial involving 3,600 HIV seronegative HSV2 seropositive participants in the USA, Latin Amercia and Africa.
The trial aims to determine whether twice daily suppressive therapy with acyclovir can reduce the risk of HIV acquisition in HSV-2 positive HIV seronegative women who have sex with men (WSM) in Africa, and men who have sex with men (MSM) in the US and South America.
The secondary objectives are to determine the effect of twice daily acyclovir in reducing the occurrence and the frequency of genital herpes ulcers in these populations, as well as to assess adherence to twice daily suppressive therapy in these individuals.
The 039 protocol has an ancillary study for the follow up of identified seroconverters, titled a Prospective cohort study of HPTN039 seroconverters - the effect of HSV-2 suppression on viral set point.
This site is the only South African site in the trial.
Recruitment began in August 2004 and was completed in May 2006. Over 1,400 women were counseled and tested for HIV and HSV-2. Four hundred eligible participants were enrolled in the trail.
Each participant is followed up for a period of 18 months. Participants are seen on a monthly basis for risk reduction counseling and dispensing of study drug and condoms. At quarterly visits, participants are counseled and tested for HIV. All participants receive free condoms, STI treatment, health education and referral to medical services. The last participant is expected to exit the study in December 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 prevent high risk individuals from becoming
- Contribution to voluntary counseling and testing services in the Cith of Johannesburg
- Formation of an active Community Advisory Group
- Contribution to proposal on adherence to study medication
- Contribution to survey on acyclovir availability
- Contribution to WHO guidelines for acyclovir in HIV+ persons
If results are positive, there will be a need for operational research to test the implementation of this strategy within the public sector.
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