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

Inclusion Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.