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 | https://doi.org/10.1186/ISRCTN35385041 |
| Secondary identifying numbers | 066688 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 06/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Deborah Watson-Jones
Scientific
Scientific
London School of Hygiene and Tropical Medicine
Department of Infectious and Tropical Diseases
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7927 2116 |
|---|---|
| deborah.watson-jones@lshtm.ac.uk |
Study information
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 |
| Study acronym | AMREF HSV Project |
| Study objectives | 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(s) | Ethics approval received from the London School of Hygiene and Tropical Medicine ethics committee and the Medical Research Coordinating Committee of Tanzania |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/10/2003 |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1305 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- England
- Tanzania
- United Kingdom
Study participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
London School of Hygiene and Tropical Medicine (UK)
University/education
University/education
Research Grants and Contracts Office
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 (0)20 7827 2678 |
|---|---|
| Penny.Ireland@lshtm.ac.uk | |
| Website | http://www.lshtm.ac.uk |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/04/2008 | Yes | No | |
| Results article | results | 01/09/2009 | Yes | No | |
| Results article | results | 01/05/2010 | Yes | No |
