Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC

Inclusion Criteria

Concurrent Medication:

Allowed:

• Modest doses of acetaminophen, aspirin, or non-prescription doses of ibuprofen may be used with caution for fever control and mild analgesia. Prolonged use more than 72 hours is not advised without dose supervision.

All patients should have a documented history of positive HIV antibody by ELISA test. Patients should qualify for zidovudine (AZT) treatment for the following reasons:

• Patients with a prior episode of cytologically confirmed Pneumocystis carinii pneumonia (PCP).
• Patients with a prior episode of any AIDS-defining opportunistic infection and less than 200 T4 cells.
• Patients with advanced ARC as defined by mucocutaneous candidiasis and/or unexplained weight loss and less than 200 T4 cells and fever more than 100 degrees F of more than 3 weeks duration; clinical diagnosis of hairy leukoplakia; herpes zoster infection within 3 months of entry; or unexplained diarrhea.
• All patients must have received at least 8 weeks of AZT prior to enrollment and must not have required a dose adjustment for the previous 4 weeks.
• Patients must be willing to sign an informed consent statement.

Required:

• Zidovudine (AZT) for at least 8 weeks.

Exclusion Criteria

Co-existing Condition:

The following patients will be excluded:

• Patients receiving zidovudine (AZT) while enrolled in another protocol.
• Patients with other life-threatening and uncontrolled opportunistic infection.
• Patients with evidence of lymphoma or neoplasm other than indolent Kaposi's sarcoma.
• Dementia that would prevent giving appropriate informed consent.

Concurrent Medication:

Excluded:

• Acetaminophen or products containing acetaminophen.
• Drugs that are nephrotoxic, are cytotoxic, or decrease blood cell number or function may increase the risk of toxicity.

Probenecid may inhibit excretion of zidovudine (AZT). Some experimental nucleoside analogs should be avoided.

The following patients will be excluded:

• Patients receiving zidovudine (AZT) while enrolled in another protocol.
• Patients with other life-threatening and uncontrolled opportunistic infection.
• Patients with evidence of lymphoma or neoplasm other than indolent Kaposi's sarcoma.
• Dementia that would prevent giving appropriate informed consent.

Prior Medication:

Excluded within 8 weeks of study entry:

• Prior systemic therapy with an antimetabolite, cytotoxic drug, interferon, immunomodulator, corticosteroid, or nucleoside analog other than zidovudine.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety