The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: January 24, 2008
Last Verified: June 1999
History of Changes
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.
Drug : Valacyclovir hydrochloride
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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
All patients are treated for 10 days.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
- 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.
- Suppressive treatment with medication that has anti-HSV activity.
- Stable antiretroviral therapy or no therapy for at least 1 month.
Patients with the following symptoms or conditions are excluded: ~#o1~ Hepatic impairment.
Patients with the following prior conditions are excluded:
History of hypersensitivity to acyclovir or valacyclovir.
Contacts and LocationsChoosing 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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002404
Sponsors and CollaboratorsGlaxo Wellcome
|Responsible Party:||Glaxo Wellcome|
|ClinicalTrials.gov Identifier:||NCT00002404 History of Changes|
|Other Study ID Numbers:||291A|
|Study First Received:||November 2, 1999|
|Last Updated:||January 24, 2008|
Keywords provided by NIH AIDS Clinical Trials Information Service:HIV-1
Herpesvirus 2, Human
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on March 16, 2018
This information is provided by ClinicalTrials.gov.