A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study examines the safety and effectiveness of ritonavir (an anti-HIV drug), alone and in combination with other anti-HIV drugs, in HIV-positive children under 2 years of age. This study will also determine the most effective doses of ritonavir for future pediatric HIV studies.

Infants infected with HIV by their mothers experience faster disease progression than adults or older children. Treatment with anti-HIV drugs administered at an early age may slow disease progression in infant populations.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Lamivudine; Ritonavir; Zidovudine

Criteria

Inclusion Criteria

Children may be eligible for this study if they:

• Are HIV-positive. (Infants under 3 months old presumed to be HIV-positive are eligible to participate in the single-dose phase of the study.)

• Are between the ages of 4 weeks and 2 years (consent of parent or guardian required).

Exclusion Criteria

Children will not be eligible for this study if they:

• Have an opportunistic (AIDS-related) infection within 2 months of study entry.

• Are allergic to 3TC and/or ZDV.

• Have received anti-HIV drugs for 6 to 12 weeks.

• Have any infections requiring treatment.

• Are experiencing wasting (significant weight loss).

• Have any malignancies (cancer).

• Have certain immune diseases, are being fed through a tube, or have HIV-related encephalopathy (a degenerative disease of the brain).