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Episodic Acyclovir Therapy for Genital Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00164424
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 11, 2012
London School of Hygiene and Tropical Medicine
National Institute for Communicable Diseases, South Africa
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
HIV Infections Ulcer Herpes Simplex Drug: Acyclovir Phase 2 Phase 3

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 recognized as a risk factor for HIV in multiple studies. A substantial shift in the aetiology of genital ulcer disease (GUD) towards genital herpes has been noted in many countries in Africa, especially those with mature HIV epidemics. Some countries guided by the predominance of HSV-2 as the aetiology of GUD in their country, are changing syndromic guidelines to include acyclovir as part of the treatment for GUD. Little data is available to support this decision in terms of its effect on clinical course and its cost-effectiveness. Yet, substantial investment would be needed in poor countries to add acyclovir to their essential drug list. Studies to determine the appropriateness of episodic acyclovir therapy for HSV-2 in the developing world are needed.

Episodic therapy with acyclovir both as a treatment modality and as an HIV-prevention strategy is appealing, in terms of cost and sustainability. However, it is not clear which will be its impact under field conditions in which there would be delay in symptom recognition and treatment initiation, and whether these conditions could be optimized through patient education. We propose to conduct a randomized placebo-controlled trial of the effect of HSV-2 episodic therapy on symptomatic herpes and on HIV shedding from genital ulcers. This study will help answer the question if acyclovir therapy for herpes should be added into the syndromic management of genital ulcer disease. Acyclovir has an acceptable profile for widespread STI treatment and is now relatively inexpensive and well-tolerated. Given that HSV-2 is the leading cause of GUD in the developing world, this approach could have great public health importance, by providing a safe, acceptable, and cost-effective method to treat genital ulcer disease and potentially reduce HIV transmission. If acyclovir therapy reduces HIV shedding, its incorporation into syndromic management would provide and effective way to scale it up as a public health intervention.

Methods: We plan an individually randomized double blind placebo-control trial of the WHO and US CDC recommended dose of 3-times daily acyclovir for a 5-day treatment course. The trial will be conducted at two primary health care clinics in Johannesburg, South Africa. A total of 600 men presenting to the clinic with GUD will be enrolled in the study. Consenting participants will be randomized to receive either acyclovir plus syndromic management or placebo plus syndromic management. Syndromic management for genital ulcer disease will consist of one dose antibiotics to cover for syphilis and chancroid. Participants will be followed for a month; during follow-up visits duration of ulcers, ulcer number and size will be evaluated and ulcer, blood and semen samples collected to test for HIV RNA viral loads among HIV-positives and for HSV-2 shedding.

Timeline: Duration of the project is 2 years

Expected Outcomes: The main outcome of the study will be the evaluation of the impact of acyclovir therapy on ulcer healing. We will also measure the impact of acyclovir therapy on HIV and HSV-2 viral load from genital ulcers and HIV viral load in semen.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Impact of Episodic Acyclovir Therapy on Ulcer Duration and HIV Shedding From Genital Ulcers Among Men in South Africa
Study Start Date : March 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Ulcer healing

Secondary Outcome Measures :
  1. HIV viral load from genital ulcers
  2. HIV viral load in semen

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00164424

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South Africa
Eloff Street Clinic
Johannesburg, Gauteng, South Africa
Green Door, Alexandra Health Centre
Johannesburg, Gauteng, South Africa
Sponsors and Collaborators
Centers for Disease Control and Prevention
London School of Hygiene and Tropical Medicine
National Institute for Communicable Diseases, South Africa
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centers for Disease Control and Prevention Identifier: NCT00164424    
Other Study ID Numbers: CDC-NCHSTP-4294
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012
Keywords provided by Centers for Disease Control and Prevention:
genital ulcer
South Africa
Additional relevant MeSH terms:
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Herpes Simplex
Virus Diseases
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents