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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
Est. completion date
Est. primary completion date
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


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, 

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