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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002125
• Other study ID #: 020H
• Secondary ID: 93-FOS-31
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Foscarnet sodium

Locations

Country	Name	City	State
United States	Ingenix Kern McNeill Decatur	Atlanta	Georgia
United States	Austin Infectious Disease Consultants	Austin	Texas
United States	Dr Paul Benson	Berkley	Michigan
United States	Dr Ralph Hansen	Beverly Hills	California
United States	Dr John Karedes	Indianapolis	Indiana
United States	Dr G Michael Wool	Los Angeles	California
United States	Dr Milan Fiala	Los Angeles	California
United States	Dr Ronald J Grossman	New York	New York
United States	AIDS Community Research Consortium	Redwood City	California
United States	Community Health Network	Rochester	New York
United States	Dr Ronald Nahass	Somerville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Astra USA

Country where clinical trial is conducted

United States,