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

Astra USA

Status and phase: Completed; Phase 4

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Foscarnet sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002125

93-FOS-31

020H

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.