The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
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ClinicalTrials.gov Identifier: NCT00002404 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: January 29, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Herpes Simplex HIV Infections | Drug: Valacyclovir hydrochloride | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Masking: | Double |
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 |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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
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.
ClinicalTrials.gov Identifier: | NCT00002404 History of Changes |
Other Study ID Numbers: |
291A |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | January 29, 2008 |
Last Verified: | June 1999 |
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 Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents |