Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
13/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 Specified

Drug names

Aciclovir

Primary outcome measures

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

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 - recruitment ends on 30th April 2006

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

30/04/2007

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

http://www.lshtm.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 066688)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes