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

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.

Completed

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Cytomegalovirus Infections DNA Virus Infections Digestive System Diseases Gastrointestinal Diseases Genital Diseases Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

East Bay AIDS Ctr, Berkeley, California, United States

About this study

Patients receive intravenous foscarnet either as induction only for 4 weeks or as induction for 4 weeks followed by maintenance for 22 weeks. All patients are followed for 26 weeks or until relapse.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foscarnet sodium

Drug

Sponsors and collaborators

Lead sponsor

Astra USA

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed