A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients

HIV Infections Clinical Trial

Official title:

A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002000
• Other study ID #: 104A
• Secondary ID: 08
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100).

Description:

Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Patients must have the following:

• HIV-infected individual (CD4 = or > 100) with a history of recurrent anogenital herpes.

• Signed the consent form or present a signed parental consent form if below 18 years.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy.

Patients with the following are excluded:

• Hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine.

• History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy.

Prior Medication:

Excluded:

• Systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex
• Herpesviridae Infections
• HIV Infections
• Infection

Intervention

Drug:
• Valacyclovir hydrochloride

• Acyclovir

Locations

Country	Name	City	State
United States	Univ of New Mexico School of Medicine	Albuquerque	New Mexico
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	Emory Univ School of Medicine	Atlanta	Georgia
United States	Northwestern Memorial Hosp	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ of Cincinnati	Cincinnati	Ohio
United States	Denver Public Health Dept / Disease Control Services	Denver	Colorado
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Infectious Diseases Research Clinic / Indiana Univ Hosp	Indianapolis	Indiana
United States	Univ of Mississippi Med Ctr	Jackson	Mississippi
United States	Univ of South Alabama	Mobile	Alabama
United States	Vanderbilt School of Medicine	Nashville	Tennessee
United States	Louisiana State Univ Med School	New Orleans	Louisiana
United States	Saint Vincent's Hosp and Med Ctr	New York	New York
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Roger Williams Med Ctr	Providence	Rhode Island
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	ViRx Inc	San Francisco	California
United States	Univ of Washington / Pacific Med Ctr	Seattle	Washington
United States	Univ of South Florida	Tampa	Florida
United States	West Haven Veterans Administration Med Ctr	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,