Status:
COMPLETED
Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
University of Washington
Johns Hopkins University
Conditions:
HIV Infections
Herpes Genitalis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2 (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and HSV-2 infecti...
Detailed Description
Interventions that slow HIV-1 disease progression among persons with CD4+ counts above 250 cells/microliter could postpone the need for antiretroviral therapy (ART) and prolong life-expectancy for HIV...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Documentation of HIV-1 infection, by either two positive ELISAs or two discrepant ELISAs with a confirmatory positive Western Blot
- Documentation of prior HSV-2 infection by Focus Kalon ELISA
- Absolute CD4+ T-cell count of greater than or equal to 300 and less than or equal to 400 cells/microliter within 30 days prior to randomization
- All participants must be receiving Cotrimoxazole prophylaxis as part of standard care unless contraindicated
- Age at least 18 years and above
- Laboratory values (within 30 days prior to randomization)
- Aspartate transaminase (AST) no more than five times the upper limit of normal (ULN)
- Total bilirubin no more than 2 times ULN
- Creatinine no more than 2.0 mg/dL
- Platelet count at least 50 000/microliter
- Hemoglobin at least 8g/dL
- Written informed consent
- EXCLUSION CRITERIA:
- Concurrent malignancy or any other disease state requiring cytotoxic chemotherapy
- Symptomatic for significant HIV-related illnesses (WHO stage III or IV), such as opportunistic infections and malignancies other than mucocutaneous Kaposi's sarcoma. A history of AIDS defining opportunistic infections other than mucocutaneous Kaposi's sarcoma or candida or treated tuberculosis
- Active HSV-2 disease as suggested by painful genital ulcer disease at time of screening or enrollment
- Current use of antiretroviral medications or Preventing Mother-to-Child Transmission (PMTCT) use of antiretrovirals within the previous 6 months
- Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as detectable on routine medical history, physical examination, or screening laboratory studies.
- Psychiatric illness that, in the opinion of the PI, might interfere with the study compliance.
- Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or patient safety.
- CD4+ count less than 300 or more than 400 cells/microliter.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00405821
Start Date
November 1 2006
End Date
November 1 2010
Last Update
September 28 2012
Active Locations (1)
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1
Rakai Health Sciences Program, Uganda Virus Research Institute
Kalisizo, Rakai District, Uganda