A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002125|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Retinitis HIV Infections||Drug: Foscarnet sodium||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||112 participants|
|Official Title:||A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)|
Choosing 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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|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.
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.
- 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) within 7 days prior to study entry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002125
|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|
|Study Chair:||Wool GM|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||June 1997|
Acquired Immunodeficiency Syndrome
Eye Infections, Viral
DNA Virus Infections
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action