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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000983
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
• Scientific title: A Randomized Blinded Trial To Evaluate the Safety and Tolerance of High Versus Low Dose Zidovudine Administered to Children With Human Immunodeficiency Virus
• Date of first enrolment: November 1999
• Target sample size: 400
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000983
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: M Brady

• Name: P Weintrub

Key inclusion & exclusion 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.



Age minimum: 3 Months
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Zidovudine

Secondary ID(s)

11103

ACTG 128

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Glaxo Wellcome