|
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome Clinical research trials and Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome. Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome clinical trial. Test subjects typically receive the most expert healthcare available for their Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome  Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To explore the safety and usefulness of foscarnet, an antiviral agent, in the treatment of cytomegalovirus (CMV) retinitis. Untreated CMV retinitis is a rapidly progressive, blinding disease in AIDS patients. The manner in which foscarnet breaks down in the body and the effect of increasing periodic intravenous doses are also studied. Foscarnet is active in vitro (test tube) against herpes viruses, including CMV, by inhibiting the virus DNA polymerases, enzymes necessary for virus replication, without affecting cellular DNA polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis, colitis, esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has been used to treat AIDS patients with CMV disease but can cause severe neutropenia (very low neutrophil cell counts). Foscarnet does not suppress the production of neutrophils or other leukocytes (myelosuppression) and has shown in vitro activity against HIV.
Details: Foscarnet is active in vitro (test tube) against herpes viruses, including CMV, by inhibiting the virus DNA polymerases, enzymes necessary for virus replication, without affecting cellular DNA polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis, colitis, esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has been used to treat AIDS patients with CMV disease but can cause severe neutropenia (very low neutrophil cell counts). Foscarnet does not suppress the production of neutrophils or other leukocytes (myelosuppression) and has shown in vitro activity against HIV. Treatment is given for a total of 10 weeks with a 2-week induction regimen followed by randomization to daily maintenance foscarnet for 8 weeks. If induction therapy is tolerated without unexpected toxicity, patients are allowed to self-administer foscarnet at home via central venous catheter and may receive up to 11 days of induction therapy by self-administration on an outpatient basis. Foscarnet will be administered in open-label fashion so that both investigator and patient will know the dose. Within the study, there are 8 patients who upon entering the 2nd week of maintenance foscarnet therapy are treated with zidovudine (AZT).
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Both
Protocol Entry Criteria: Exclusion Criteria Concurrent Medication: Excluded: - Acyclovir. - Zidovudine (AZT). - Any potentially nephrotoxic agent, especially aminoglycosides, pentamidine, or amphotericin B. Prior Medication: Excluded: - Ganciclovir. - Foscarnet. - Excluded within 7 days of study entry: - Any potentially nephrotoxic agent. - Excluded within 14 days of study entry: - Cytomegalovirus hyperimmune globulin in therapeutic doses. - Immunomodulators. - Biologic response modifiers. - Investigational agents. - Amphotericin B maintenance for a systemic mycosis. Known allergy to foscarnet. Active AIDS-defining opportunistic infection other than cytomegalovirus (CMV) including systemic mycosis, pulmonary or neurologic impairment (comatose). Patient must be diagnosed as having: - AIDS CDC Group IV.C. - Cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography. - One pending culture for CMV from blood and urine prior to study entry.
Total Enrollment: 53
Location and Contact Information:
Overall Study Official:
JacobsonM, Study Chair,
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: ACTG 015; FDA 20D
Study Start Date:
Record last reviewed: February 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000726
Other Cytomegalovirus Retinitis Studies:
1. Tuberculosis in HIV Infected Patients in Uganda
2. The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms
3. A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients between Ages 4 and 22 with 7 Drugs, Some at Higher than Usual Doses
4. Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
5. Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
|
|
|
|
|
|
|
|
