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
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
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
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Oakland, California, United States
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Bronx, New York, United States
Brooklyn, New York, United States
New York, New York, United States
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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
Patients applied
Trial Officials
M Brady
Study Chair
P Weintrub
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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