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A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma Clinical research trials and A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma health trials occur in a lot of of places 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma. A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma clinical trial. Human subjects frequently get the finest healthcare available for their A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma  A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma
A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan. Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
Details: Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions. Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day, and the second receiving AZT for 3 doses per day. A placebo group is divided into two to match the two treatment groups. Study patients are stratified according to whether they have (a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2 months, every other week for the next 2 months, and monthly thereafter.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or localized or disseminated zoster infections. Concurrent Treatment: Allowed: - Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's cardiovascular status is compromised or if the hemoglobin fails to show signs of recovery following withdrawal from the study drug. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults). Patients must have: - HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without constitutional symptoms. Exclusion Criteria Co-existing Condition: Patients with the following conditions will be excluded: - Symptomatic, visceral Kaposi's sarcoma. - Lymphedema. - HIV neurologic disease as determined by a standard neurologic examination and neuropsychological questionnaire. Concurrent Medication: Excluded: - Aspirin or acetaminophen on a regular basis or for longer than 72 hours without approval of investigator. - Cimetidine. - Flurazepam. - Indomethacin. - Ranitidine. - Probenecid. - Drugs causing anemia, neutropenia, or significant risk of nephrotoxicity. - Prophylaxis or chronic suppression of herpes simplex. - Treatment of herpes simplex virus cutaneous disease more often than once a month for 5 - 7 days. Concurrent Treatment: Excluded: - Radiation therapy for treatment of Kaposi's sarcoma lesions. The following patients will be excluded from the study: - Patients with a history of any AIDS-defining opportunistic infection. - Patients with any of the following constitutional symptoms with no etiology established: - Temperature more than 38 degrees and/or drenching night sweats for more than 1 month; watery diarrhea for 2 or more weeks; weight loss of more than 10 percent. - Patients with a history of other systemic malignancies or lymphomas. Prior Medication: Excluded: - Systemic antineoplastic chemotherapy. - Zidovudine (AZT). - Excluded within 30 days of study entry: - Antiretroviral agents. - Immunomodulating agents. - Prophylaxis for Pneumocystis carinii pneumonia. - Prophylaxis for herpes simplex virus infections. - Any other experimental therapy. Prior Treatment: Excluded within 30 days of study entry: - Any experimental therapy. - Active substance abuse.
Total Enrollment: 240
Location and Contact Information:
Overall Study Official:
ValentineFT, Study Chair,
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Additional Information:
Study ID Numbers: ACTG 001;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000994
Other Hiv Infections Studies:
1. A Study of Zidovudine in HIV-Infected Patients with Kidney Problems
2. ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
3. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
4. A Study of Zidovudine in HIV-Infected Patients with Liver Disease
5. Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma
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