The Effect of Treatment With Valacyclovir 500 mg BID on the Detection of HIV From Genital HSV Lesions in HIV-Infected Patients: A Double-Blind Crossover Study
Valacyclovir hydrochloride
Blood-Borne Infections+28
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: Hepatic impairment. Impaired renal function (creatinine above 2 mg/dl). Malabsorption syndrome or other gastrointestinal dysfunction. 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.