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Home > "A" Clinical Trials Conditions > A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children  A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children
A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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 enrolled simultaneously into dosage Cohort I, at the initial drug dosage. Progression to Cohort II (at a higher or lower drug dosage) will be decided according to safety, tolerance or viral load in Cohort I. All therapy for Group I/II, whether in Cohort I or II, will be introduced as follows: single dose of ritonavir on Day 0, ritonavir monotherapy through Day 7 AM and combination therapy from Day 7 PM through Week 104. All therapy for Group IIIA & IIIB, whether in Cohort I or II, will be introduced as follows: single dose of ritonavir on Day 0 AM and transition to combination therapy Day 0 PM through Week 104. NOTE: Progression to combination therapy for Group IIIA infants is dependent upon the results of the single-dose ritonavir pharmacokinetics (PK). If the patient is no longer at least presumed to be HIV-infected, he/she will be discontinued from the study. Replacement infants, who will not receive the single dose of ritonavir, will be acquired from Group IIIB infants; new infants that are either presumed HIV infected or have already been shown to be HIV-infected. Clinical evaluations are conducted and blood and urine samples collected regularly during the treatment period in order to quantify HIV-1 levels and determine body chemistries. Pharmacokinetic studies require additional blood sampling up to Week 16. [AS PER AMENDMENT 6/30/98: Pharmacokinetics data from Cohort I showed that the proposed Cohort II starting dose was too low. The dose for Cohort II is now increased. All subjects in Groups I, II, and III will begin combination therapy on Day 0 at the increased dose.] [AS PER AMENDMENT 3/13/00: The study has been extended for an additional 104 weeks, provided the patient's viral load is undetectable (below 400 copies/ml) at the end of the initial study period. While on the treatment extension, patients must continue their current schedule for study drug administration and completion of study visits.]
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 1 Month/2 Years
Genders: Both
Protocol Entry 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).
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
RamYogev, Study Chair,
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Additional Information:
Study ID Numbers: ACTG 345; PACTG 345
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000952
Other Hiv Infections Studies:
1. Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants
2. The Biology of HIV Transmission
3. Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.
4. A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma
5. Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
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A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children
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