|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000697 |
To study the safety and effectiveness of foscarnet in the treatment of AIDS patients who have active infection with cytomegalovirus (CMV) that is causing inflammation of the retina (retinitis). In addition, these patients cannot be treated with ganciclovir (DHPG) because of its toxic effect on the body's blood-forming cells or because white blood cell or platelet counts were too low.
CMV is a common virus, which can cause blindness and death in AIDS patients. Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection. Although treatment with ganciclovir (DHPG) is also effective, a significant toxicity leading to dose-limiting neutropenia (low white blood cell count) in one third of treated patients has been associated with the drug. Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients, the present study will evaluate the safety and efficacy of intravenous (IV) foscarnet in AIDS patients with CMV retinitis.
Condition | Intervention | Phase |
Cytomegalovirus Retinitis HIV Infections |
Drug: Foscarnet sodium |
Phase II |
MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
Drug Information available for: | Ganciclovir Ganciclovir sodium Foscarnet Foscarnet sodium Fosfonet sodium Phosphonoacetic acid |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | A Phase II Randomized Controlled Trial of Immediate Versus Delayed Foscarnet Therapy in AIDS Patients With Non-Immediately Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due to Myelosuppression |
Estimated Enrollment: | 168 |
CMV is a common virus, which can cause blindness and death in AIDS patients. Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection. Although treatment with ganciclovir (DHPG) is also effective, a significant toxicity leading to dose-limiting neutropenia (low white blood cell count) in one third of treated patients has been associated with the drug. Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients, the present study will evaluate the safety and efficacy of intravenous (IV) foscarnet in AIDS patients with CMV retinitis.
Following routine evaluation studies, patients are randomized to receive foscarnet right away or to delay treatment, as their retinitis has been determined not to be immediately sight-threatening. Patients are hospitalized for the first 3 days and may remain hospitalized for as many as 14 days. Foscarnet is given by vein (IV) in what is called induction therapy, and if the patient's retinitis stabilizes after 2 weeks of treatment, treatment with foscarnet is continued in maintenance therapy for another 8 weeks. During maintenance therapy, patients receive salt solution IV to help prevent any toxic side effect of foscarnet on the kidneys. Patients have regular checkups to monitor their retinitis as well as their general health. Patients taking zidovudine (AZT) prior to entering the study may continue their treatment if they are selected for the delayed treatment group; if they are selected for the immediate treatment group, they begin or resume AZT therapy when they enter the 2nd week of maintenance therapy. Patients are followed as outpatients for at least 10 weeks, with clinic check-ups and lab tests once every week; eye exams are done once a week for the first 2 weeks and then every other week. If clinically indicated, a continued maintenance regimen may be administered after the 10th week; the total duration of therapy plus maintenance is not to exceed 24 weeks. Note: Patients scheduled for the delayed foscarnet treatment are immediately given foscarnet at the first sign that their retinitis is getting worse.
Ages Eligible for Study: | 13 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed if hematologically stable on that regimen for at least 30 days prior to study entry:
Patients must have active AIDS-related cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography. Patients must also demonstrate one of the following clinical and/or laboratory findings:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following diseases or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients will be excluded from the study if they are unwilling or unable to suspend zidovudine (AZT) treatment during the first 3 weeks of the study period (1) if randomized to the immediate treatment arm, or (2) when crossed-over from the delayed treatment arm to foscarnet therapy because of retinitis progression.
Prior Medication:
Excluded:
United States, California | |||||
Univ of California / San Diego Treatment Ctr | |||||
San Diego, California, United States, 921036325 | |||||
San Francisco AIDS Clinic / San Francisco Gen Hosp | |||||
San Francisco, California, United States, 941102859 | |||||
United States, District of Columbia | |||||
George Washington Univ Med Ctr | |||||
Washington, District of Columbia, United States, 20037 | |||||
United States, Massachusetts | |||||
Harvard (Massachusetts Gen Hosp) | |||||
Boston, Massachusetts, United States, 02114 | |||||
United States, New York | |||||
SUNY - Stony Brook | |||||
Stony Brook, New York, United States, 117948153 | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
Mount Sinai Med Ctr | |||||
New York, New York, United States, 10029 | |||||
Saint Luke's - Roosevelt Hosp Ctr | |||||
New York, New York, United States, 10025 | |||||
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |||||
Bronx, New York, United States, 10461 | |||||
United States, Ohio | |||||
Ohio State Univ Hosp Clinic | |||||
Columbus, Ohio, United States, 432101228 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 |
Study Chair: | MA Jacobson | |
Study Chair: | CS Crumpacker |
Study ID Numbers: | ACTG 092 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000697 |
Health Authority: | United States: Federal Government |
|
|
|
|
|
|