Search / Trial NCT00000994

A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Aids Related Opportunistic Infections Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Zidovudine

Description

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 s...

Gender

Male

Eligibility 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.

Attachments

readout_NCT00000994_2024-06-14.pdf

4.5 MB

NCT00000994_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

New York, New York, United States

San Diego, California, United States

New York, New York, United States

Rochester, New York, United States

Durham, North Carolina, United States

San Francisco, California, United States

Baltimore, Maryland, United States

Buffalo, New York, United States

Elmhurst, New York, United States

Syracuse, New York, United States

Los Angeles, California, United States

New York, New York, United States

San Francisco, California, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Stanford, California, United States

Boston, Massachusetts, United States

Bronx, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
3 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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