HIV Infections Clinical Trial
Official title:
Impact of Episodic Acyclovir Therapy on Ulcer Duration and HIV Shedding From Genital Ulcers Among Men in South Africa
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.
Status | Completed |
Enrollment | 613 |
Est. completion date | July 2011 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - Extensive ulceration - Ulceration >1 month - History of adverse reaction to acyclovir - Taking suppressive therapy for genital herpes - History of renal insufficiency or proteinuria |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | Eloff Street Clinic | Johannesburg | Gauteng |
South Africa | Green Door, Alexandra Health Centre | Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | London School of Hygiene and Tropical Medicine, National Institute for Communicable Diseases, South Africa |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ulcer healing | |||
Secondary | HIV viral load from genital ulcers | |||
Secondary | HIV viral load in semen |
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---|---|---|---|
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