Contact information
Type
Scientific
Primary contact
Dr Deborah Watson-Jones
ORCID ID
Contact details
London School of Hygiene and Tropical Medicine
Department of Infectious and Tropical Diseases
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2116
deborah.watson-jones@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
066688
Study information
Scientific 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
Acronym
AMREF HSV Project
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Human immunodeficiency virus (HIV)
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Aciclovir
Primary outcome measure
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 measures
No secondary outcome measures
Overall trial start date
01/10/2003
Overall trial end date
30/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1305
Participant 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
Recruitment start date
01/10/2003
Recruitment end date
30/04/2006
Locations
Countries of recruitment
Tanzania
Trial participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
London School of Hygiene and Tropical Medicine (UK)
Sponsor details
Research Grants and Contracts Office
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7827 2678
Penny.Ireland@lshtm.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Results
Watson-Jones D, Weiss HA, Rusizoka M, Changalucha J, Baisley K, Mugeye K, Tanton C, Ross D, Everett D, Clayton T, Balira R, Knight L, Hambleton I, Le Goff J, Belec L, Hayes R, , , Effect of herpes simplex suppression on incidence of HIV among women in Tanzania., N. Engl. J. Med., 2008, 358, 15, 1560-1571, doi: 10.1056/NEJMoa0800260.
-
Results
Baisley K, Changalucha J, Weiss HA, Mugeye K, Everett D, Hambleton I, Hay P, Ross D, Tanton C, Chirwa T, Hayes R, Watson-Jones D, Bacterial vaginosis in female facility workers in north-western Tanzania: prevalence and risk factors., Sex Transm Infect, 2009, 85, 5, 370-375, doi: 10.1136/sti.2008.035543.
-
Results
Tanton C, Weiss HA, Rusizoka M, Legoff J, Changalucha J, Baisley K, Mugeye K, Everett D, Belec L, Clayton TC, Ross DA, Hayes RJ, Watson-Jones D, Long-term impact of acyclovir suppressive therapy on genital and plasma HIV RNA in Tanzanian women: a randomized controlled trial., J. Infect. Dis., 2010, 201, 9, 1285-1297, doi: 10.1086/651696.