Status:
COMPLETED
Episodic Acyclovir Therapy for Genital Ulcers
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
London School of Hygiene and Tropical Medicine
National Institute for Communicable Diseases, South Africa
Conditions:
HIV Infections
Ulcer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
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.
Detailed Description
Background and Objectives: Herpes simplex virus type 2 (HSV-2) is the primary cause of genital ulcer and one of the most prevalent sexually transmitted infections (STI) worldwide. HSV-2 has been recog...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Extensive ulceration
- Ulceration \>1 month
- History of adverse reaction to acyclovir
- Taking suppressive therapy for genital herpes
- History of renal insufficiency or proteinuria
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
613 Patients enrolled
Trial Details
Trial ID
NCT00164424
Start Date
March 1 2005
End Date
July 1 2011
Last Update
September 11 2012
Active Locations (2)
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1
Eloff Street Clinic
Johannesburg, Gauteng, South Africa
2
Green Door, Alexandra Health Centre
Johannesburg, Gauteng, South Africa