Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir

Inclusion Criteria

Concurrent Medication:

Allowed for phase B:

• Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia (PCP).

Prior Medication:

Allowed for phase A:

• Ganciclovir. Patients receiving this drug at the time of study enrollment must discontinue the drug at the time of enrollment and for the duration of the study period.

Exclusion Criteria

Co-existing Condition:

For phase A, patients with pre-existing severe neurologic impairment such as seizure disorder or marked or incapacitating ataxia are excluded.

Concurrent Medication:

Excluded upon entry into phase B:

• Ganciclovir.
• Immunomodulators.
• Probenecid.
• Ciprofloxacin.
• Allopurinol.
• Zidovudine (AZT).
• Antiretrovirals.
• Other investigational agents.
• Acyclovir for another labeled indication.
• Potentially nephrotoxic agents.

Patients will be excluded from the study for the following reasons:

Phase A:

• Previous hypersensitivity reaction to foscarnet or vidarabine. Patients who have a documented history of vidarabine intolerance may be eligible for the foscarnet on the non-randomized arm of the study.

Phase B:

• Clinical response to therapy with acyclovir in phase A described as "healed" or "good."

Prior Medication:

Excluded within 14 days of study entry:

• Immunomodulators or biologic response modifiers.

Phase A:

• Excluded within 30 days of study entry:
• Foscarnet.

Phase B:

Excluded within 7 days of study entry into phase B:

• Any potentially nephrotoxic agent, except acyclovir.

Prior Treatment:

Excluded for phase A within 14 days of study entry:

• Lymphocyte replacement therapy.

Patients must demonstrate the following clinical and laboratory findings:

Phase A:

• HIV positive by federally licensed ELISA test confirmed by Western blot, p24 serum antigen, or a positive HIV culture; or a prior diagnosis of AIDS as defined by Centers for Disease Control criteria.
• Mucocutaneous herpes simplex virus (HSV) infection confirmed by viral culture persisting for a minimum of 2 weeks which is clinically resistant to therapy with acyclovir in the opinion of the patient's physician.

Phase B:

• Persistent shedding of HSV at the completion of or within 1 week after completion of phase A acyclovir therapy as confirmed by viral culture.

Documented in vitro resistance of the virus to acyclovir.

• All strains must be referred to the Diagnostic Virology Laboratories at either San Francisco General Hospital or Beth Israel Hospital, Boston, for susceptibility testing.
• Two serum acyclovir levels drawn during phase A. Results may be pending at time of entry into phase B.
• All eligibility evaluations must be performed within 7 days prior to study entry for phase A or B.