A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002125
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002125 on ClinicalTrials.gov Archive Site
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A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)

To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate the timing and volume of oral fluid hydration required to establish a diuresis before and during intravenous Foscavir therapy. To assess the general tolerance of two hydration regimens by the adverse event profile associated with each.

Patients are randomized to receive oral hydration versus intravenous hydration therapy during concomitant intermittent intravenous Foscavir therapy for treatment of cytomegalovirus (CMV) retinitis. Treatment continues during 2 or 3 weeks of induction Foscavir therapy.

Interventional
Phase 4
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Foscarnet sodium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
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Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • Recent diagnosis of CMV retinitis, by ophthalmoscopic appearance, that requires induction therapy.
  • No corneal, lens, or vitreous opacification that precludes examination of the fundi.
  • No evidence of other end organ CMV infection.
  • No evidence of tuberculous, diabetic, or hypertensive retinopathy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Clinically significant cardiac, pulmonary, neurologic, gastrointestinal or renal impairment that would prevent adequate voluntary oral hydration (e.g., intubation, coma, status post-gastrectomy, colon resection, gastrointestinal tumors, malabsorption, chronic diarrhea) OR with which hydration would be hazardous (e.g., congestive heart failure).
  • Known allergy to foscarnet or related compounds.
  • Considered noncompliant or unreliable for study participation.

Concurrent Medication:

Excluded:

  • Any investigational drug.
  • Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin).

Prior Medication:

Excluded:

  • Any investigational drug within 28 days prior to study entry.
  • Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin) 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
 
NCT00002125
020H, 93-FOS-31
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Astra USA
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Study Chair: Wool GM
NIH AIDS Clinical Trials Information Service
June 1997

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