Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT00002404
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002404
Study Brief:
Protocol Section:
NCT00002404