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

This study has been completed.
Sponsor:
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
  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:

Estimated Enrollment: 30
Detailed Description:

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

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:

  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.

  Contacts and Locations
Choosing 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.

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 August 20, 2014