A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Foscarnet sodium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) |
| Estimated Enrollment: | 112 |
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 |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| United States, California | |
| Dr Ralph Hansen | |
| Beverly Hills, California, United States, 90210 | |
| Dr G Michael Wool | |
| Los Angeles, California, United States, 90067 | |
| Dr Milan Fiala | |
| Los Angeles, California, United States, 900246970 | |
| 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 | |
| Study Chair: | Wool GM |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002125 History of Changes |
| Other Study ID Numbers: | 020H, 93-FOS-31 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Retinitis Infusions, Intravenous Foscarnet Cytomegalovirus Infections |
Administration, Oral Acquired Immunodeficiency Syndrome Fluid Therapy |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Retinal Diseases Eye Diseases |
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Foscarnet Phosphonoacetic Acid Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013