Berkeley, California 94705

  • Herpes Genitalis


The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.

Study summary:

Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation. Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator. Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months). The total duration of the study for all patients is 6 months.


Inclusion Criteria Patients may be eligible for this study if they: - Are at least 18 years old. - Are HIV-positive. - Have herpes simplex virus (HSV) 2. - Have received combination anti-HIV therapy for at least 2 months before entering the study. - Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.) - Agree to use effective methods of birth control from 2 weeks before taking study drug, throughout the study, and for 4 weeks after completing the study. (A female may be eligible if not able to have children.) Exclusion Criteria Patients will not be eligible for this study if they: - Have blood vessel disease. - Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir. - Are unable to take medications by mouth. - Have non-healed sores on the anus or genitals at beginning of study. - Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary. - Are using interferon. Patients receiving interferon must stop interferon before beginning the study. - Have kidney or liver problems. - Are pregnant or breast-feeding. - Have a type of HSV that is resistant to acyclovir, Valtrex, famciclovir, or ganciclovir.

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients

Official Title:

An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects

Overall Status:

Active, not recruiting

Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Endpoint Classification: Safety Study, Masking:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Study Dates

Start Date:June 1999
Verification Date:July 2001
Last Changed Date:June 23, 2005
First Received Date:May 11, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Valacyclovir hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Glaxo Wellcome

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: September 23, 2021

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