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A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) Clinical research trials and A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium). A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) clinical trial. Subjects typically recieve the finest healthcare available for their A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)  A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Astra USA ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 112
Location and Contact Information:
Overall Study Official:
WoolGM, Study Chair,
Ingenix Kern McNeill Decatur
Atlanta, Georgia, 30309
United States
Austin Infectious Disease Consultants
Austin, Texas, 78705
United States
Dr Paul Benson
Berkley, Michigan, 48072
United States
AIDS Community Research Consortium
Redwood City, California, 94063
United States
Dr Ralph Hansen
Beverly Hills, California, 90210
United States
Dr Ronald Nahass
Somerville, New Jersey, 08876
United States
Community Health Network
Rochester, New York, 14620
United States
Dr Ronald J Grossman
New York City, New York, 10016
United States
Dr John Karedes
Indianapolis, Indiana, 46204
United States
Dr Milan Fiala
Los Angeles, California, 900246970
United States
Dr G Michael Wool
Los Angeles, California, 90067
United States
Additional Information:
Study ID Numbers: 020H; 93-FOS-31
Study Start Date:
Record last reviewed: June 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002125
Other Hiv Infections Studies:
1. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
2. Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
3. Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
4. An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies
5. A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
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A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
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