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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002145
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002145 on ClinicalTrials.gov Archive Site
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Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
  • HIV Infections
  • Gastrointestinal Diseases
Drug: Foscarnet sodium
Not Provided
Dieterich DT, Poles MA, Lew EA, Martin-Munley S, Johnson J, Nix D, Faust MJ. Treatment of gastrointestinal cytomegalovirus infection with twice-daily foscarnet: a pilot study of safety, efficacy, and pharmacokinetics in patients with AIDS. Antimicrob Agents Chemother. 1997 Jun;41(6):1226-30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002145
020I, 93-FOS-29
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Astra USA
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NIH AIDS Clinical Trials Information Service
March 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP