Search / Trial NCT00000750

A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

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

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Trial Information

Current as of December 03, 2023

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

Description

AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic. Patients are randomized to receive oral AZT (at age-adjusted doses) or placebo. Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter; those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient sho...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • HIV infection.
  • CD4 count >= 2000 cells/mm3 AND >= 30 percent of total lymphocytes.
  • No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted).
  • Consent of parent or guardian.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Serious acute infection requiring parenteral therapy at time of entry.
  • One or more serious, proven bacterial infections including any of the following:
  • septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria.
  • Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile.
  • Concurrent Medication:
  • Excluded:
  • Any agent with known antiretroviral activity.
  • Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously.
  • Prior Medication:
  • Excluded:
  • More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally.
  • Recommended:
  • PCP prophylaxis.
  • Immunizations according to current recommendations.

Attachments

readout_NCT00000750_2023-12-03.pdf

4.5 MB

NCT00000750_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

Springfield, Massachusetts, United States

San Francisco, California, United States

Bronx, New York, United States

Birmingham, Alabama, United States

Downey, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

San Francisco, California, United States

Denver, Colorado, United States

New Haven, Connecticut, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Newark, New Jersey, United States

Albany, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Brooklyn, New York, United States

Buffalo, New York, United States

Great Neck, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Valhalla, New York, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

San Juan, , Puerto Rico

Newark, New Jersey, United States

Farmington, Connecticut, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, 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
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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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