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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Acyclovir; Valacyclovir

Criteria

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.