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| Sponsor: | Astra USA |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002301 |
Purpose
To evaluate the safety and efficacy of foscarnet induction treatment of cytomegalovirus (CMV) retinitis in AIDS patients who have previously suffered severe dose-limiting ganciclovir-related myelosuppression, who are ineligible for ganciclovir treatment due to myelosuppression or who have clearly failed to have a therapeutic response to ganciclovir therapy. To assess the duration of clinical response. To evaluate the effect on quantitative CMV cultures of blood and urine. To determine the effect on recovery of HIV p24 antigen capture direct from plasma.
| Condition | Intervention |
|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Foscarnet sodium |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Foscarnet Treatment of Cytomegalovirus (CMV) Retinitis in AIDS Patients Not Eligible for Ganciclovir Therapy and Ganciclovir Treatment Failures |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 7 days of study entry:
AIDS patients experiencing cytomegalovirus (CMV) retinitis may be enrolled if they meet one of the following criteria:
Patients who enter the study because of ganciclovir toxicity will have received ganciclovir therapy which resulted in either absolute neutrophil count falling to < 750 cells/mm3 or platelet count falling to < 50000 platelets/mm3 on two separate occasions during either
1) a ganciclovir induction regimen of 7.5 mg or less ganciclovir/kg/day in divided doses or 2) a maintenance regimen of 5 mg or less ganciclovir/kg/day as a single dose.
1) CMV retinitis progression as defined in section V.C.1., i.e., has occurred either at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10.0 mg/kg/day in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 or more mg/kg/day in at least 5 days/week) where maintenance therapy began within
Contacts and Locations
More Information
| Study ID Numbers: | 020B, 88-FOS-02 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002301 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Retinitis AIDS-Related Opportunistic Infections Ganciclovir Foscarnet |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Phosphonoacetic Acid Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Retinitis Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors Retinal Diseases RNA Virus Infections Immune System Diseases |
Eye Infections, Viral Eye Diseases Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Enzyme Inhibitors Ganciclovir Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |