Episodic Acyclovir Therapy for Genital Ulcers
Impact of Episodic Acyclovir Therapy on Ulcer Duration and HIV Shedding From Genital Ulcers Among Men in South Africa
1 other identifier
interventional
613
1 country
2
Brief Summary
The purpose of this study is to determine if acyclovir episodic treatment has an effect in ulcer healing and if it should be added to the syndromic management of genital ulcer disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Mar 2005
Longer than P75 for phase_2 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 11, 2012
September 1, 2012
4 years
September 9, 2005
September 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ulcer healing
Secondary Outcomes (2)
HIV viral load from genital ulcers
HIV viral load in semen
Interventions
Eligibility Criteria
You may qualify if:
- Males presenting at the primary health care clinic with a genital ulcer
- Age 18 years or older
- Willing and able to give informed consent
- Willing to be tested for HSV and HIV
- Willing and able to comply with the study protocol including follow-up visits
- Willing to accept therapy by chance
You may not qualify if:
- Extensive ulceration
- Ulceration \>1 month
- History of adverse reaction to acyclovir
- Taking suppressive therapy for genital herpes
- History of renal insufficiency or proteinuria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eloff Street Clinic
Johannesburg, Gauteng, South Africa
Green Door, Alexandra Health Centre
Johannesburg, Gauteng, South Africa
Related Publications (2)
Paz Bailey G, Sternberg M, Lewis DA, Puren A. Acute HIV infections among men with genital ulcer disease in South Africa. J Infect Dis. 2010 Jun 15;201(12):1811-5. doi: 10.1086/652785.
PMID: 20443734DERIVEDPaz-Bailey G, Sternberg M, Puren AJ, Markowitz LE, Ballard R, Delany S, Hawkes S, Nwanyanwu O, Ryan C, Lewis DA. Improvement in healing and reduction in HIV shedding with episodic acyclovir therapy as part of syndromic management among men: a randomized, controlled trial. J Infect Dis. 2009 Oct 1;200(7):1039-49. doi: 10.1086/605647.
PMID: 19715417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriela Paz Bailey, MD
Centers for Disease Control and Prevention
- PRINCIPAL INVESTIGATOR
David Lewis, MD
STIRC, National Institute for Communicable Diseases (NICD), South Africa
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
March 1, 2005
Primary Completion
March 1, 2009
Study Completion
July 1, 2011
Last Updated
September 11, 2012
Record last verified: 2012-09