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Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis Clinical research trials and Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis. Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis clinical trial. Subjects frequently get the best healthcare possible for their Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis  Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Schering-Plough ,
Synopsis: To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patient must have the following: - AIDS as defined by CDC criteria. - Retinitis as diagnosed by the study ophthalmologist. - Performance status 0, 1, or 2. - Ability to give informed consent and suitability of intravenous access for scheduled blood tests. - Patient may have Kaposi's sarcoma or basal skin cancer. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Active acute infection requiring treatment. - Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy. - Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer. Patients with the following are excluded: - Active acute infection requiring treatment. - Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy. - Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer. Prior Medication: Excluded: - Granulocyte macrophage colony-stimulating factor (GM-CSF). - Colony stimulating factor. - Interleukin 3. - Excluded within 7 days of study entry: - Zidovudine (AZT). - Trimethoprim / sulfamethoxazole (TMP / SMX). - Pyrimethamine. - Excluded within 30 days of study entry: - Biologic response modifiers. - Cytotoxic agents. - Investigational agents. Prior Treatment: Excluded: - Radiation therapy. Required within 1 week of study entry: - One or more doses of ganciclovir.
Total Enrollment:
Location and Contact Information:
Gottlieb Med Group
Sherman Oaks, California, 91403
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Children's Hosp of San Francisco
San Francisco, California, 94118
United States
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Pacific Presbyterian
San Francisco, California, 94118
United States
Methodist Hosp
Houston, Texas, 77030
United States
Dr Douglas Dieterich
New York City, New York, 10016
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Cabrini Med Ctr
New York City, New York, 10003
United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: 005A; C88-059
Study Start Date:
Record last reviewed: May 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002070
Other Cytomegalovirus Retinitis Studies:
1. A Study of WF 10 IV Solution in Patients with Advanced HIV Disease
2. Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia
3. Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
4. Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, including Long-term Non-progressors
5. A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients with Late-Stage HIV Disease
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
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