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Clinical epidemiology of Herpes Simplex Virus type two and the impact of interventions against sexually transmitted infections to reduce human immunodeficiency virus incidence in high risk women from gold mining communities in Tanzania
ISRCTN ISRCTN35385041
DOI 10.1186/ISRCTN35385041
ClinicalTrials.gov identifier
EudraCT number
Public title Clinical epidemiology of Herpes Simplex Virus type two and the impact of interventions against sexually transmitted infections to reduce human immunodeficiency virus incidence in high risk women from gold mining communities in Tanzania
Scientific title
Acronym AMREF HSV Project
Serial number at source 066688
Study hypothesis The main aim of this trial is to determine whether intervening against herpes simplex virus type 2 (HSV-2) using suppressive therapy with aciclovir will reduce the acquisition of human immunodeficiency virus (HIV) in HIV-negative women and whether suppressive therapy will reduce genital HIV and HSV viral shedding in women who are HIV-infected.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the London School of Hygiene and Tropical Medicine ethics committee and the Medical Research Coordinating Committee of Tanzania.
Study design Double blind randomised placebo controlled trial
Countries of recruitment Tanzania
Disease/condition/study domain Human immunodeficiency virus (HIV)
Participants - inclusion criteria 1. Aged 16 to 35 years
2. HSV-2 seropositive
3. Not planning to leave study sites within next 24 months
4. No history of epilepsy
5. Able to understand aims and procedures of trial
Participants - exclusion criteria 1. Pregnant or planning pregnancy within next 24 months
2. HSV-2 seronegative or indeterminate
3. Breastfeeding at time of enrolment
4. History of epilepsy
5. Temporary visitor in study sites
6. Unable to give informed consent
Anticipated start date 01/10/2003
Anticipated end date 30/04/2007
Status of trial Completed
Patient information material
Target number of participants 1305 - recruitment ends on 30th April 2006
Interventions A double-blind, randomised, placebo-controlled trial of HSV-2 suppressive therapy with aciclovir 400 mg twice a day (bd), as a strategy to reduce HIV incidence, HSV-2 and HIV viral shedding. The trial is being conducted in a cohort of female bar, guesthouse and other recreational facility workers in goldmining communities and along truck-routes in NW Tanzania.

Please note that this trial has extended follow-up to 30 months for first 1001 participants enrolled and enrolled another 304 participants who will be followed for 12 months. Therefore there is a new anticipated end date of 30th April 2007. The previous anticipated end date was 30/09/2006.
Primary outcome measure(s) HIV acquisition study:
1. HIV incidence by treatment arm
2. Frequency of genital ulceration by treatment arm
3. Adherence to therapy

HIV-positive women at enrolment:
1. Prevalence and quantity (log copies/ml) of cervico-vaginal HIV-1 RNA shedding by treatment arm
2. Plasma viral load by treatment arm
3. Prevalence and quantity of cervico-vaginal proviral HIV-1 DNA shedding
4. Prevalence and quantity of cervico-vaginal HSV-2 DNA shedding
5. Adherence to therapy
Secondary outcome measure(s) No secondary outcome measures
Sources of funding The Wellcome Trust (UK) (grant ref: 066688)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18337596
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19473997
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20235836
Contact name Dr  Deborah  Watson-Jones
  Address London School of Hygiene and Tropical Medicine
Department of Infectious and Tropical Diseases
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Tel +44 (0)20 7927 2116
  Fax +44 (0)20 7612 7860
  Email deborah.watson-jones@lshtm.ac.uk
Sponsor London School of Hygiene and Tropical Medicine (UK)
  Address Research Grants and Contracts Office
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Tel +44 (0)20 7827 2678
  Fax +44 (0)20 7927 5636
  Email Penny.Ireland@lshtm.ac.uk
  Sponsor website: http://www.lshtm.ac.uk
Date applied 22/07/2005
Last edited 13/03/2013
Date ISRCTN assigned 22/07/2005
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