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A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure Clinical research trials and A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure. A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure clinical trial. Participants frequently obtain the most expert healthcare available for their A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure  A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To examine the usefulness and safety of the antiviral drug foscarnet in treating AIDS patients with cytomegalovirus (CMV) infection that is causing sight-threatening inflammation of the retina in one or both eyes (CMV retinitis). Because of the seriousness of sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for those patients who cannot be treated with ganciclovir (DHPG) (because of its toxic effect on the body's blood-forming cells, because it did not control the disease, or because patient's blood cell or platelet counts are too low to begin with), it is worthwhile to try an immediate trial with foscarnet. AMENDED: ACTG 093 was originally designed as a randomized dose-ranging study of foscarnet maintenance therapy. Patients enrolled between March 17, 1989, and January 1, 1990, received either 60 mg/kg/day or 90/mg/kg day as maintenance therapy following the 2 week induction period. Based on the preliminary results of ACTG 015/915, which studied maintenance doses of foscarnet of 60 mg/kg/day, 90 mg/kg/day and 120 mg/kg/day, the 60-mg/kg/day and 90/mg/kg/day arms of this study have been closed. All patients entering the study beginning January 2, 1990 will receive foscarnet maintenance therapy on a 120/mg/kg/day algorithm following induction.
Details: Because of the seriousness of sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for those patients who cannot be treated with ganciclovir (DHPG) (because of its toxic effect on the body's blood-forming cells, because it did not control the disease, or because patient's blood cell or platelet counts are too low to begin with), it is worthwhile to try an immediate trial with foscarnet. AMENDED: ACTG 093 was originally designed as a randomized dose-ranging study of foscarnet maintenance therapy. Patients enrolled between March 17, 1989, and January 1, 1990, received either 60 mg/kg/day or 90/mg/kg day as maintenance therapy following the 2 week induction period. Based on the preliminary results of ACTG 015/915, which studied maintenance doses of foscarnet of 60 mg/kg/day, 90 mg/kg/day and 120 mg/kg/day, the 60-mg/kg/day and 90/mg/kg/day arms of this study have been closed. All patients entering the study beginning January 2, 1990 will receive foscarnet maintenance therapy on a 120/mg/kg/day algorithm following induction. AMENDED: The ACTG 093 optional extended maintenance therapy period will conclude on January 2, 1991 in order to facilitate timely analysis of this study. All patients who wish to continue foscarnet therapy should be referred to Astra Protocol 90-FOS-14 at telephone number 800-292-5775. Original design: Patients are placed into two groups: (1) patients who have a sight-threatening lesion in the retina of an eye with vision that can be saved (corrected vision of 20/100 or better) and who cannot be treated with DHPG, and (2) patients whose retinitis has quickly gotten worse and/or has shown resistance to DHPG treatment. Both groups will receive a beginning (induction) dose of foscarnet by vein (IV) for 2 weeks, followed by a maintenance dose for 8 weeks with an option to continue up to 24 weeks. AMENDED: Patients entering the study on or after 01/02/90 receive the standard two week course of foscarnet induction therapy and receive maintenance therapy. Treatment is given for a ten week study period or until progression occurs or toxicity endpoints are reached. If retinitis is stable and foscarnet well-tolerated, maintenance therapy may be extended for a period not to exceed 1 year.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. - Oral antibiotics if patient is hematologically stable on that regimen for at least 30 days prior to study entry. - Therapy with vancomycin. - Drug therapy for Kaposi's sarcoma if patient is hematologically stable for at least 30 days prior to study entry. - Initiate or resume zidovudine (AZT) in 2nd week of foscarnet maintenance therapy at dose of 100 or 200 mg q4h at investigator's discretion. - Initiate or continue erythropoietin therapy via the treatment IND mechanism. - Initiate or continue therapy with investigational triazoles for disseminated fungal infections. Caution should be used in concurrent use of foscarnet and ciprofloxacin, as such use has appeared to exacerbate renal failure in one patient. Prior Medication: Allowed: - Oral antibiotics if patient is hematologically stable on that regimen for at least 30 days prior to study entry. - Drug therapy for Kaposi's sarcoma if patient is hematologically stable for at least 30 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Corneal, lens, or vitreous opacification that precludes examination of the fundi. - Clinically significant pulmonary or neurologic impairment, including intubation or coma. - Karnofsky performance status = or < 50. Concurrent Medication: Excluded: - Immunomodulators. - Biologic response modifiers. - Investigational agents (other than erythropoietin and investigational triazoles). - Ganciclovir. - Didanosine (ddI). - Systemic acyclovir. - CMV hyperimmune serum / globulin. - Interferons. - Nephrotoxic agents including aminoglycosides, amphotericin B, parenteral pentamidine. - Caution should be used in the concurrent use of foscarnet and ciprofloxacin, as such use has appeared to exacerbate renal failure in one patient. Patients with the following are excluded: - Corneal, lens, or vitreous opacification that precludes examination of the fundi. - Clinically significant pulmonary or neurologic impairment, including intubation or coma. - Unwilling or unable to suspend zidovudine treatment until 2nd week of foscarnet maintenance therapy. Prior Medication: Excluded: - Foscarnet for cytomegalovirus retinitis. - Systemic acyclovir. - Immunomodulators. - Biologic response modifiers. - Investigational agents (other than erythropoietin and investigational triazoles). AIDS patients with active cytomegalovirus (CMV) retinitis who cannot be treated with ganciclovir. At least one pending CMV culture from both blood (buffy-coat) and urine must be obtained prior to study entry. Patients must be able to give informed consent. Patients with a history of a seizure disorder or central nervous system mass lesion will be included.
Total Enrollment: 156
Location and Contact Information:
Overall Study Official:
MAJacobson, Study Chair,
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Washington
Seattle, Washington, 98105
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Lakeside Veterans Adm / Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: ACTG 093;
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000691
Other Cytomegalovirus Retinitis Studies:
1. Valganciclovir in Patients with CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
2. A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
3. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
4. A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients with AIDS
5. Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
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