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CompletedNCT00002404Updated Jan 29, 2008

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

An interventional study of Valacyclovir hydrochloride in Herpes Simplex and HIV Infections, sponsored by Glaxo Wellcome. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-29.

Sponsored by Glaxo Wellcome · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Herpes Simplex
  • HIV Infections

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Keywords

  • HIV-1
  • Antiviral Agents
  • Herpes Genitalis
  • Recurrence
  • DNA, Viral
  • RNA, Viral
  • valacyclovir
  • Herpesvirus 2, Human
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 30 is below the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
Double
Enrollment
30 participants

Interventions

  • DrugValacyclovir hydrochloride
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002404
Lead sponsor
Glaxo Wellcome
First posted
Aug 31, 2001
Last update
Jan 29, 2008
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 1999. You cannot join it, but the record below documents what was studied.

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