Search / Trial NCT00001011

The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

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

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Virus Replication Aids Related Complex Zidovudine

Description

In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL. Patients accepted into the study are randomly assigned to receive either AZT or placebo. Treatment conti...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit.
  • The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be < 800 cells/mm3, and at least 1 of 2 counts and the mean must be > 200 cells/mm3). The last count must be within 14 days of study entry.
  • Concurrent Medication:
  • Allowed:
  • Acetaminophen and acetaminophen products but use should be minimized. Continuous use for > 72 hours is discouraged.
  • Aerosolized pentamidine.
  • Prior Medication:
  • Allowed:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer if patient has CD4(+) count < 200 cells/mm3 measured on 2 determinations at least 48 hours apart.
  • Exclusion Criteria
  • Concurrent Medication:
  • Excluded:
  • Other antiretroviral agents, biologic modifiers or corticosteroids.
  • Other experimental medications.
  • Systemic chemoprophylaxis of Pneumocystic carinii pneumonia (PCP) - aerosolized pentamidine is allowed.
  • Prior Medication:
  • Excluded:
  • Zidovudine (AZT).
  • Other antiretroviral agents.
  • Excluded within 30 days of study entry:
  • Biologic modifiers or corticosteroids.
  • Excluded within 60 days of study entry:
  • Ribavirin.
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Blood transfusions.
  • Patients may not have any of the following diseases or symptoms:
  • Active oral candidiasis at entry.
  • An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
  • Temperature > 38.5 degrees C persisting for > 14 consecutive days or > 15 days in a 30-day interval present at entry.
  • Chronic diarrhea defined as = or > 3 liquid stools per day, persisting for > 14 days without a definable cause during the past 2 years.
  • HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
  • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.
  • Patients may not have any of the following diseases or symptoms:
  • Active oral candidiasis at entry.
  • An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
  • Temperature > 38.5 degrees C persisting for > 14 consecutive days or > 15 days in a 30-day interval present at entry.
  • Chronic diarrhea defined as = or > 3 liquid stools per day, persisting for > 14 days without a definable cause during the past 2 years.
  • HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
  • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.
  • Active drug or alcohol abuse.

Attachments

readout_NCT00001011_2024-03-05.pdf

4.5 MB

NCT00001011_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

Indianapolis, Indiana, United States

Saint Louis, Missouri, United States

Bronx, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

San Francisco, California, United States

Torrance, California, United States

Miami, Florida, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Bronx, New York, United States

Bronx, New York, United States

Buffalo, New York, United States

Elmhurst, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Philadelphia, Pennsylvania, United States

Los Angeles, California, United States

New York, New York, United States

Palo Alto, California, United States

Pittsburgh, Pennsylvania, United States

Minneapolis, Minnesota, United States

Stanford, California, United States

Washington, District Of Columbia, United States

Boston, Massachusetts, United States

Bronx, New York, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, 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
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

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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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