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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000994 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Zidovudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
Official Title: | A Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma |
Estimated Enrollment: | 240 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions will be excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
The following patients will be excluded from the study:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 30 days of study entry:
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
Stanford at Kaiser / Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Stanford Univ School of Medicine | |
Stanford, California, United States, 94305 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Louisiana State Univ Med Ctr / Tulane Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
SUNY / State Univ of New York | |
Syracuse, New York, United States, 13210 | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Bronx Veterans Administration / Mount Sinai Hosp | |
Bronx, New York, United States, 10468 | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
Beth Israel Med Ctr / Peter Krueger Clinic | |
New York, New York, United States, 10003 | |
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
Elmhurst, New York, United States, 11373 | |
United States, North Carolina | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Valentine FT |
Study ID Numbers: | ACTG 001 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000994 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Zidovudine |
Opportunistic Infections Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Zidovudine Soft tissue sarcomas Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Neoplasms Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Neoplasms, Vascular Tissue Nucleic Acid Synthesis Inhibitors |