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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To evaluate and compare differences in tolerance and side effects associated with two different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other goals are to evaluate and compare the degree of change in neurodevelopmental disease and determine whether there are differences in the rate and degree of toxicities associated with one versus the other dosage. 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 learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied.

Key facts

Study ID

NCT00000983

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

400

Expected to finish

1994-12-01

Last updated by the study team

2021-11-04

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Children's Hosp of Los Angeles/UCLA Med Ctr — Los Angeles, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Cedars Sinai / UCLA Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• Children's Hosp of Oakland — Oakland, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Northern California Pediatric AIDS Treatment Ctr / UCSF — San Francisco, California, United States
• Univ of Connecticut Health Ctr / Pediatrics — Farmington, Connecticut, United States
• Children's Natl Med Ctr — Washington D.C., District of Columbia, United States
• Ctr for Special Immunology — Fort Lauderdale, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Emory Univ School of Medicine — Atlanta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Univ of Maryland at Baltimore / Univ Med Ctr — Baltimore, Maryland, United States
• Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Boston Med Ctr — Boston, Massachusetts, United States
• Univ of Massachusetts Med Ctr — Worcester, Massachusetts, United States
• Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl — Newark, New Jersey, United States
• SUNY / Health Sciences Ctr at Brooklyn / Pediatrics — Brooklyn, New York, United States
• Jewish Hosp Ctr of Long Island / Pediatrics — Jamaica, New York, United States
• Kaiser Permanente / UCLA Med Ctr — Downey, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.