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Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma 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 Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma Clinical research trials and Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma 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 Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma. Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma 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 Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma clinical trial. Test subjects typically receive the most expert healthcare available for their Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma 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.
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Home > "P" Clinical Trials Conditions > Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma  Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.
Details: In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens. Following evaluation studies, patients who participate in the study receive IFN-A2a and AZT. IFN-A2a is administered as a single subcutaneous injection once a day. AZT is given in a single capsule every 4 hours through the day for a total of six capsules. The first phase of treatment continues for 8 weeks followed by a 1-week rest period, during which time AZT only is given. Subjects who have had an interruption in interferon during the first 8 weeks of the study for a toxicity may skip the rest period. Patients experiencing a complete response will be placed on maintenance therapy. Patients without progression of their KS can continue on the treatment of AZT and IFN-A2a until a complete response is obtained or until study is terminated, whichever comes first. Patients with complete anti-tumor response can continue on a maintenance phase, in which they receive IFN-A2a as a single injection 3 times a week on nonconsecutive days and a single capsule of AZT q4h 6 x /day until the study is terminated on February 1, 1992. Patients are required to visit the clinic weekly for the first 12 weeks (except during the week 9 rest period), every other week for the next 8 weeks, every month for up to 52 weeks of the study and every 3 months thereafter. Throughout the study, frequent blood samples will be taken to monitor the effectiveness and safety of the treatment.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Inhalation pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) at a dose of 300 mg once every 4 weeks. - AMENDED: Trimethoprim - sulfamethoxazole or dapsone only if on the maintenance phase of the study. Concurrent Treatment: Allowed: - Blood transfusions. Patients must have a positive antibody to HIV by any federally licensed ELISA test. All lab tests must be within 7 days of entry into the study. Exclusion Criteria Concurrent Medication: Excluded: - Other antiretroviral agents. - Immunomodulators. - Corticosteroids. - Cytotoxic chemotherapy. - Aspirin. - H2 blockers. - Barbiturates and myelosuppressive drugs should be particularly avoided as they may interfere with the metabolism or enhance the toxicities of either zidovudine or interferon alfa-2a. - Other experimental medications. Concurrent Treatment: Excluded: - Radiation therapy. Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded from the study. Prior Medication: Excluded: - Interferon therapy. - Excluded within 30 days of study entry: - Immunomodulators. - Corticosteroids. - Cytotoxic chemotherapeutic agents. - Excluded within 14 days of study entry: - Zidovudine (AZT). Prior Treatment: Excluded within 30 days of study entry: - Blood transfusions. - Radiation therapy. Patients may not have any of the following diseases or symptoms: - Active opportunistic infection associated with AIDS. - Significant neurologic disease associated with AIDS, as manifested by motor abnormalities including impaired rapid eye movement or ataxia, motor weakness in the lower extremities, sensory deficit consistent with a peripheral neuropathy, bladder or bowel incontinence. - Internal organ involvement with Kaposi's sarcoma, i.e., nonnodal visceral Kaposi's sarcoma, excluding minimal gastrointestinal disease of less than 5 lesions. - Tumor-associated edema. - Current neoplasm other than Kaposi's sarcoma. - Significant cardiac disease, including a recent history of myocardial infarction or significant current cardiac arrhythmias. Active drug or alcohol abuse.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
MFischl, Study Chair,
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: ACTG 096;
Study Start Date:
Record last reviewed: October 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000687
Other Hiv Infections Studies:
1. A Study of Ro 24-7429 in Patients with HIV-Related Kaposi's Sarcoma
2. A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
3. Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
4. Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
5. A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
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