Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age.
Ellen Gould Chadwick, John H Rodman, Paula Britto...
https://pubmed.ncbi.nlm.nih.gov/16148846Completed
Phase 1
Age: 1Month - 2Years
All Genders
ID00000952
A Phase I/II Study of Ritonavir Therapy in HIV-1 Infected Infants and Children
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
60
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children
Who Can Participate
Age: 1Month - 2Years
All Genders
Eligibility Criteria
You may qualify if you...
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).
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 12 locations
1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90806
Status Unknown
2
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 92103
Status Unknown
3
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20060
Status Unknown
4
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
Status Unknown
5
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
Status Unknown
6
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States, 10016
Status Unknown
7
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Status Unknown
8
Columbia IMPAACT CRS
New York, New York, United States, 10032
Status Unknown
9
Incarnation Children's Ctr.
New York, New York, United States, 10032
Status Unknown
10
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Status Unknown
11
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
12
St. Jude/UTHSC CRS
Memphis, Tennessee, United States, 38105
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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