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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agouron Pharmaceuticals
• Treatments: Nelfinavir

Criteria

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.