The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
This study has been completed.
Sponsor:
Glaxo Wellcome
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002404
First received: November 2, 1999
Last updated: January 24, 2008
Last verified: June 1999
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Herpes Simplex HIV Infections |
Drug: Valacyclovir hydrochloride |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002404 History of Changes |
| Other Study ID Numbers: | 291A |
| Study First Received: | November 2, 1999 |
| Last Updated: | January 24, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Antiviral Agents Herpes Genitalis Recurrence |
DNA, Viral RNA, Viral valacyclovir Herpesvirus 2, Human |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013