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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

As a group, vertically infected children experience more rapid disease progression than children infected at an older age or adults. The early administration of potent antiretroviral regimens might significantly impact the course of vertical HIV-1 infection.

Infants and children are stratified by age, representative of the developmental differences related to drug metabolism (Group I: at least 6 months - 2 years, Group II: 3-6 months, Group IIIA: 1 month - 10 weeks, IIIB: 1 month - less than 3 months). Within each age group there will be two possible dosage cohorts. All age groups will be ...

Gender

ALL

Eligibility 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).