CClinicalTrials.gg
CompletedNCT00002145Updated Jun 24, 2005

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

A Phase 3 interventional study of Foscarnet sodium in HIV Infections and Gastrointestinal Diseases, sponsored by Astra USA. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Astra USA · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
145
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • HIV Infections
  • Gastrointestinal Diseases

Keywords

  • Foscarnet
  • Cytomegalovirus Infections
  • Acquired Immunodeficiency Syndrome
03

In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's enrollment of 145 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Astra USA is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have:

  • AIDS.
  • CMV GI disease.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Enrollment
145 participants

Interventions

  • DrugFoscarnet sodium
06

Study locations

15 sites
  • East Bay AIDS Ctr
    Berkeley, California 94705, United States
  • Los Angeles County - USC Med Ctr
    Los Angeles, California 90033, United States
  • UCSD
    San Diego, California 92103, United States
  • UCSF - San Francisco Gen Hosp
    San Francisco, California 94110, United States
  • Miami Veterans Administration Med Ctr
    Miami, Florida 33125, United States
  • Emory Univ School of Medicine
    Atlanta, Georgia 30303, United States
  • Rush Presbyterian - Saint Luke's Med Ctr
    Chicago, Illinois 60612, United States
  • Dr Robert Bresalier / Henry Ford Hosp
    Detroit, Michigan 48202, United States
  • Dr Douglas Dieterich
    New York, New York 10016, United States
  • Dept of Veterans Affairs
    Northport, New York 11768, United States
  • Ohio State Univ Hosp
    Columbus, Ohio 43210, United States
  • Comprehensive Care Ctr
    Dallas, Texas 75235, United States
  • Univ TX Galveston Med Branch
    Galveston, Texas 77555, United States
  • Houston Veterans Administration Med Ctr
    Houston, Texas 77030, United States
  • Med College of Virginia
    Richmond, Virginia 232980711, United States
07

References and documents

Publications

  • 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. doi: 10.1128/AAC.41.6.1226. PubMed 9174175 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002145
Lead sponsor
Astra USA
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 1996. You cannot join it, but the record below documents what was studied.

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