Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Retinitis, Infusions, Intravenous, Foscarnet, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome, Fluid Therapy
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.
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.
Interventions
DRUGFoscarnet sodium
Sponsors
Astra USA
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed