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

Completed · Phase 4

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002125

Run by

Astra USA

People needed

112

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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