A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection. New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.

Key facts

Study ID

NCT00000652

Run by

National Cancer Institute (NCI)

People needed

85

Expected to finish

1995-11-01

Last updated by the study team

2012-11-01

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Corticosteroids for treatment of lymphocytic interstitial pneumonitis.
• Concurrent Treatment:
• Allowed:
• Intravenous hyperalimentation.
• Patients must have the following:
• P-2 class symptomatic HIV infection as defined by CDC OR who are asymptomatic but whose total CD4 cell count is < 500 cells/mm3.
• Freedom from significant active opportunistic or other infection requiring specific therapy.
• Part B patients:
• Prior treatment with zidovudine (AZT) that was discontinued because of hematologic toxicity.
• Availability of a parent or legal guardian who is sufficiently reliable to give informed consent and follow necessary study procedures including administration of medications and return for follow-up visits.

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
• History of acute or chronic pancreatitis.
• Patients with the following are excluded:
• Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
• History of acute or chronic pancreatitis.
• Prior Medication:
• Excluded:
• Antiretroviral or other antiviral agent within 14 days of entry into study.
• Immunomodulating agents, cytolytic chemotherapeutic agents, corticosteroids within 30 days (except for lymphocytic interstitial pneumonitis).
• Part A patients:
• Zidovudine (AZT) or didanosine (ddI).
• Part B patients:
• Didanosine (ddI).
• Prior Treatment:
• Excluded:
• Radiation therapy within 30 days.
• Intravenous immunoglobulin preparations within 14 days of entry into study.

Where it is running

• Children's Hosp of Los Angeles/UCLA Med Ctr — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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