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11 February 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 |
| 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 |
| Penny.Ireland@lshtm.ac.uk | |
| Sponsor website: | http://www.lshtm.ac.uk |
| Date applied | 22/07/2005 |
| Last edited | 20/04/2010 |
| Date ISRCTN assigned | 22/07/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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