Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

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

Summary

PRIMARY: To compare the frequency of and time to relapse of Cytomegalovirus (CMV) gastrointestinal disease following foscarnet induction therapy only versus induction plus maintenance therapy.

SECONDARY: To determine frequency of and time to recurrence of gastrointestinal symptoms, response rate of pathological lesions, and incidence of nongastrointestinal CMV disease in this patient population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astra USA
• Treatments: Foscarnet; Phosphonoacetic Acid

Criteria

Inclusion Criteria

Patients must have:

• AIDS.

• CMV GI disease.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Non-GI CMV disease.

• Ulcerative colitis, inflammatory bowel disease, or other condition that may interfere with study results.

• Other GI pathogens.

Concurrent Medication:

Excluded:

• Drugs that may interact with foscarnet.

• Systemic acyclovir, ganciclovir, or acyclovir prodrug.

• Drugs known to affect renal function.

Prior Medication:

Excluded:

• Prior foscarnet in extremis.

• Investigational agents other than 3TC or d4T within 7 days prior to study entry.