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Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis conditions. Clinical Trials Search.org is a site dedicated 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 localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties 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 volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis clinical trial. Human subjects often get the best healthcare available for their Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous 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
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2. Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution
3. A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega
4. A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)
5. The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
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Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
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