Status:
COMPLETED
A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
1-2 years
Phase:
PHASE1
Brief 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...
Detailed Description
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 si...
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).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00000952
End Date
January 1 2004
Last Update
October 29 2021
Active Locations (12)
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1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90806
2
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 92103
3
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20060
4
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112