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

Sponsor

Astra USA (Industry)

Overall Status

Completed

CT.gov ID

NCT00002125

Collaborator

(none)

112

Enrollment

Locations

10.2

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Foscarnet sodium	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Ralph Hansen	Beverly Hills	California	United States	90210
2	Dr Milan Fiala	Los Angeles	California	United States	900246970
3	Dr G Michael Wool	Los Angeles	California	United States	90067
4	AIDS Community Research Consortium	Redwood City	California	United States	94063
5	Ingenix Kern McNeill Decatur	Atlanta	Georgia	United States	30309
6	Dr John Karedes	Indianapolis	Indiana	United States	46204
7	Dr Paul Benson	Berkley	Michigan	United States	48072
8	Dr Ronald Nahass	Somerville	New Jersey	United States	08876
9	Dr Ronald J Grossman	New York	New York	United States	10016
10	Community Health Network	Rochester	New York	United States	14620
11	Austin Infectious Disease Consultants	Austin	Texas	United States	78705