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The Effect of Valacyclovir on the Detection of HIV from Genital Herpes Lesions in HIV-Infected Patients



The Effect of Valacyclovir on the Detection of HIV from Genital Herpes Lesions in HIV-Infected Patients

For Condition: Herpes Simplex,HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.
Details: Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo. All patients are treated for 10 days.
Eligibility:
Study Type:  Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Serologically documented HSV-2 and HIV-1 infection. - History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study. - No contraindications to valacyclovir. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: 1. Hepatic impairment. 2. Impaired renal function (creatinine above 2 mg/dl). 3. Malabsorption syndrome or other gastrointestinal dysfunction. 4. Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol. Patients with the following prior conditions are excluded: History of hypersensitivity to acyclovir or valacyclovir. Prior Medication: Excluded: - Participation in any investigational drug trial within 1 month prior to entry on study. - Systemic anti-HSV therapy within 7 days prior to start of study drug. 1. Probenecid. - Suppressive treatment with medication that has anti-HSV activity. Required: Stable antiretroviral therapy or no therapy for at least 1 month.
Total Enrollment: 30

Location and Contact Information:

Univ of Washington Virology Research Clinic
Seattle,  Washington,  98122
United States
 


Additional Information:
Study ID Numbers:  291A; 
Study Start Date: 
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002404

Other Herpes Simplex Studies:
1. Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants

2. Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

3. Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients

4. Cause of Focal Segmental Glomerulosclerosis

5. A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC

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