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A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma Clinical research trials and A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma. A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma  A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of 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 evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics of both AZT and IFN-A or IFN-A2A when given in combination; to define the maximum tolerated dose of each drug in combination and to define doses to be used in Phase II trials. AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted.
Details: AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted. Patients are randomized to receive IFN-A or IFN-A2A (given by intramuscular injection) and combined with AZT (taken orally) daily for 8 weeks. Study stops when maximum tolerated dose (MTD) is reached. Two cohorts of 4 patients enter each dose level. Patients do not enter into the next dose level until all patients have completed 3 weeks of treatment. AZT will escalate only if there is no unacceptable toxicity (grade 2 in = or > 3 patients or > grade 2 in any patient), subsequent increases in IFN-A or IFN-A2A will be permitted, but the AZT dose will remain fixed. The MTD for a given IFN-A or IFN-A2A dose level is defined as grade 2 toxicity (grade 3 for hemoglobin, neutrophil count, or SGOT) in 4 of the 6 patients. Patients have blood drawn every week and their general health is evaluated. Pharmacokinetic studies will be done on days 1, 21, and 24. Patients tolerating the combination may be continued on the same dose level for 1 year except if patient has reached complete remission for = or > 90 days, IFN-A or IFN-A2A will decrease to 3 times a week.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patients must have biopsy-proven AIDS-associated Kaposi's sarcoma. - Evidence of HIV infection as manifested by a positive antibody test. Exclusion Criteria - Active drug or alcohol abuse. Co-existing Condition: Excluded are patients with: - Active opportunistic infections requiring ongoing therapy. - Excluded within 90 days of study entry: - Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered. - Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. - Concurrent neoplasms other than basal cell carcinoma of the skin. - Known hypersensitivity to polymycin B or neomycin. Excluded are patients with: - Active opportunistic infections requiring ongoing therapy. - Excluded within 90 days of study entry: - Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered. - Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia. - Concurrent neoplasms other than basal cell carcinoma of the skin. - Known hypersensitivity to polymycin B or neomycin. Prior Medication: Excluded: - Interferon. - Zidovudine (AZT). - Excluded within 30 days of study entry: - Any biologic modifiers, corticosteroids, cytotoxic chemotherapeutic agents. - Other drugs which can cause neutropenia or significant nephrotoxicity. - Rifampin or rifampin derivatives, or systemic anti-infectives. - Excluded within 90 days of study entry: - Other antiviral agents. - A history of Pneumocystis carinii pneumonia (PCP) completed treatment. Prior Treatment: Excluded within 30 days of study entry: - Radiation therapy.
Total Enrollment: 56
Location and Contact Information:
Overall Study Official:
FischlMA, Study Chair,
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Additional Information:
Study ID Numbers: ACTG 013;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000725
Other Sarcoma, Kaposi Studies:
1. Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma
2. Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma
3. A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma
4. Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma
5. A Study of ALRT1057 in Patients with AIDS-Related Kaposi's Sarcoma
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A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
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