Trials / Completed
CompletedNCT00002145
Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 145 (planned)
- Sponsor
- Astra USA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Foscarnet sodium |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002145. Inclusion in this directory is not an endorsement.