Search / Trial NCT00000983

The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children

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

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Trial Information

Current as of May 26, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Zidovudine

Description

AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learne...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • AMENDED:
  • 03-19-91 Prophylaxis for PCP is recommended according to current practice guidelines. As per published recommendations, primary prophylaxis with TMP / SMX on a M-T-W basis is encouraged.
  • Allowed:
  • Immunoglobulin therapy as single dose exposure prophylaxis or for children with hypogammaglobulinemia.
  • Trimethoprim / sulfamethoxazole (TMP / SMX) and parenteral or aerosolized pentamidine for prophylaxis for Pneumocystis carinii pneumonia for children with AIDS and/or CD4+ counts = or < 500 cells/mm3.
  • Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy.
  • Aerosol ribavirin for short-term treatment of acute respiratory syncytial virus (RSV).
  • AMENDED:
  • 9/17/90 enrollment is limited to children < 6 years of age.
  • Original design:
  • Patients must have the following:
  • Parent or guardian available to give written informed consent.
  • Laboratory evidence of HIV infection.
  • Children < 15 months of age, with CD4+ cell count > 500 cells/mm3, who are thought to have acquired HIV through perinatal transmission and whose only laboratory evidence of HIV infection is a positive antibody test, must also have one or more of the laboratory criteria described in Disease Status AND one or more of the disease criteria that are required of children > 15 months old with CD4+ cell counts > 500 cells/mm3.
  • Prior Medication:
  • Allowed:
  • Aerosol ribavirin.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Previous AIDS-defining opportunistic infection or neoplasms as specified by the CDC surveillance criteria for AIDS.
  • Previous unexplained recurrent, serious bacterial infections (two or more within a 2-year period) including sepsis, meningitis, pneumonia, abscess of an internal organ, and bone/joint infections caused by Haemophilus, Streptococcus, or other pyogenic bacteria.
  • Qualifying for entrance criteria to zidovudine (AZT) + or - gammaglobulin (ACTG 051).
  • Encephalopathy.
  • Failure to thrive (defined as a child who crosses two percentile lines on the growth chart or child who is < fifth percentile and does not follow curve) and/or oral candidiasis for at least 2 months despite appropriate topical therapy.
  • Lymphocytic interstitial pneumonitis (LIP) with steroid dependency or requiring supplemental oxygen.
  • Preexisting malignancies.
  • Concurrent Medication:
  • AMENDED:
  • 03-19-91 Prophylaxis with antiviral or antifungals agents, except for PCP prophylaxis is prohibited.
  • Drugs that are metabolized by hepatic glucuronidation should be used with caution.
  • Excluded:
  • Prophylaxis for oral candidiasis or otitis media or other infections (sinusitis, urinary tract infections).
  • Immunoglobulin therapy not specifically allowed.
  • Ketoconazole, acyclovir, or nystatin for prophylaxis.
  • Drugs that are metabolized by hepatic glucuronidation and might alter metabolism of zidovudine (AZT).
  • Patients with the following are excluded:
  • Previous AIDS-defining opportunistic infection or neoplasms as specified by the CDC surveillance criteria for AIDS.
  • Previous unexplained recurrent, serious bacterial infections (two or more within a 2-year period) including sepsis, meningitis, pneumonia, abscess of an internal organ, and bone/joint infections caused by Haemophilus, Streptococcus, or other pyogenic bacteria.
  • Qualifying for entrance criteria to zidovudine (AZT) + or - gammaglobulin (ACTG 051).
  • Encephalopathy.
  • Failure to thrive (defined as a child who crosses two percentile lines on the growth chart or child who is < fifth percentile and does not follow curve) and/or oral candidiasis for at least 2 months despite appropriate topical therapy.
  • Lymphocytic interstitial pneumonitis (LIP) with steroid dependency or requiring supplemental oxygen.
  • Preexisting malignancies.
  • Prior Medication:
  • Excluded within 2 weeks of study entry:
  • Any other experimental therapy or drugs that cause prolonged neutropenia or significant nephrotoxicity.
  • Excluded within 1 month of study entry:
  • Antiretroviral agents.
  • Immunomodulating agents including immunoglobulin, interferon, isoprinosine, and IL-2.
  • Excluded within 2 months of study entry:
  • Systemic ribavirin for retroviral therapy.
  • Prior Treatment:
  • Excluded within 1 month of study entry:
  • Lymphocyte or red blood cell transfusions.
  • Active alcohol or drug abuse.

Attachments

readout_NCT00000983_2024-05-26.pdf

4.5 MB

NCT00000983_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

New York, New York, United States

West Columbia, South Carolina, United States

Bronx, New York, United States

Downey, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Oakland, California, United States

San Diego, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Newark, New Jersey, United States

Bronx, New York, United States

Brooklyn, New York, United States

New York, New York, United States

New York, 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

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

Pittsburgh, Pennsylvania, United States

Houston, Texas, United States

Houston, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

Miami, Florida, United States

Los Angeles, California, United States

New York, New York, United States

Boston, Massachusetts, United States

Cincinnati, Ohio, United States

Atlanta, Georgia, United States

Fort Lauderdale, Florida, United States

Winston Salem, North Carolina, United States

San Francisco, California, United States

Farmington, Connecticut, United States

Chicago, Illinois, United States

Bronx, New York, United States

New Hyde Park, New York, United States

Valhalla, New York, United States

San Juan, , Puerto Rico

Washington, District Of Columbia, United States

Jamaica, 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
2
2 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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