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A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir Clinical research trials and A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir health trials occur in hundreds of cities 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 assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir  A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir
A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: No longer recruiting
Sponsor(s): Astra USA ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Ganciclovir. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Known allergy to foscarnet. - Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose). - Corneal, lens, or vitreous opacification which precludes examination of the fundi in patients with cytomegalovirus (CMV) retinitis. Concurrent Medication: Excluded: - Acyclovir. - Nephrotoxic agent. Patients with the following are excluded: - Known allergy to foscarnet. - Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose). - Corneal, lens, or vitreous opacification which precludes examination of the fundi in patients with CMV retinitis. Prior Medication: Excluded within 7 days of study entry: - Immunomodulators. - Biologic response modifiers. - Investigational agents. AIDS patients experiencing cytomegalovirus (CMV) retinitis may be enrolled if they meet one of the following criteria: - Myelosuppression: - Previously suffered severe dose-limiting ganciclovir-related myelosuppression, or are ineligible for ganciclovir treatment due to myelosuppression. - Ganciclovir treatment failure: - Clearly failed to have a therapeutic response to ganciclovir therapy. - Patients must be able to give informed consent. - Patients presenting with a baseline absolute neutrophil count < 750 cells/mm3 or baseline platelet count < 50000 platelets/mm3 will be categorized as ineligible to receive ganciclovir induction therapy and will be allowed to enter the study. - 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. - Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria: - 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 1 week of completing induction therapy.
Total Enrollment:
Location and Contact Information:
Foscarnet Research Program / Park Plaza Hosp
Houston, Texas, 77004
United States
Additional Information:
Study ID Numbers: 020B; 88-FOS-02
Study Start Date:
Record last reviewed: March 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002301
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A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir
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