A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: June 1997
History of Changes
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.
Drug : Foscarnet sodium
Primary Purpose: Treatment
|Official Title:||A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
- Any investigational drug.
- Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin).
- Any investigational drug within 28 days prior to study entry.
- Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin)
Patients with the following symptoms or conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002125
Locations Show More
|United States, California|
|Dr Ralph Hansen|
|Beverly Hills, California, United States, 90210|
|Dr Milan Fiala|
|Los Angeles, California, United States, 900246970|
|Dr G Michael Wool|
|Los Angeles, California, United States, 90067|
|AIDS Community Research Consortium|
|Redwood City, California, United States, 94063|
|United States, Georgia|
|Ingenix Kern McNeill Decatur|
|Atlanta, Georgia, United States, 30309|
|United States, Indiana|
|Dr John Karedes|
|Indianapolis, Indiana, United States, 46204|
|United States, Michigan|
|Dr Paul Benson|
|Berkley, Michigan, United States, 48072|
|United States, New Jersey|
|Dr Ronald Nahass|
|Somerville, New Jersey, United States, 08876|
|United States, New York|
|Dr Ronald J Grossman|
|New York, New York, United States, 10016|
|Community Health Network|
|Rochester, New York, United States, 14620|
|United States, Texas|
|Austin Infectious Disease Consultants|
|Austin, Texas, United States, 78705|
Sponsors and CollaboratorsAstra USA
|Study Chair:||Wool GM|
|Responsible Party:||Astra USA|
|ClinicalTrials.gov Identifier:||NCT00002125 History of Changes|
|Other Study ID Numbers:||020H|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Retinitis
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on August 14, 2018
This information is provided by ClinicalTrials.gov.