Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants

Inclusion Criteria

Concurrent Medication:

Allowed:

Administration of Pneumocystis carinii pneumonia prophylaxis according to CDC guidelines will be permitted.

Patients must have:

• For children >= 3 months to 13 years of age:
• HIV infection. For children <3 months of age:
• HIV infection or exposure.
• Newborns must have birth weight >= 2500 gm.
• Absence at screen of any serious or unstable medical conditions.
• Parent or guardian able to give written informed consent and willing to comply with study requirements.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

• Children with HIV associated malignancy requiring chemotherapy.
• Children with clinical or laboratory assessments greater than Grade 1 in the Toxicity Table at the time of the screening.

Concurrent Medication:

Excluded:

Chemotherapy.

Prior Medication:

Excluded:

• Protease inhibitors.

NOTE:

• Patients who have taken investigational agents, immunomodulators, HIV-1 vaccines, glucocorticoids or unconventional therapies within one month prior to the day 0 of the study must be evaluated to determine the impact of these treatments on the study. Patients may be included or excluded on a case to case basis.