Clinical trial NCT00002125: A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Official title: A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Infusions, Intravenous
Foscarnet
Cytomegalovirus Infections
Administration, Oral
Acquired Immunodeficiency Syndrome
Fluid Therapy
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Dr Ralph Hansen
state: California
city: Los Angeles
country: United States
facility: Dr Milan Fiala
state: California
city: Los Angeles
country: United States
facility: Dr G Michael Wool
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: Atlanta
country: United States
facility: Ingenix Kern McNeill Decatur
state: Georgia
city: Indianapolis
country: United States
facility: Dr John Karedes
state: Indiana
city: Berkley
country: United States
facility: Dr Paul Benson
state: Michigan
city: Somerville
country: United States
facility: Dr Ronald Nahass
state: New Jersey
city: New York
country: United States
facility: Dr Ronald J Grossman
state: New York
city: Rochester
country: United States
facility: Community Health Network
state: New York
city: Austin
country: United States
facility: Austin Infectious Disease Consultants
state: Texas
Study officials:
name: Wool GM
role: STUDY_CHAIR
References: