Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants
- Conditions
- HIV Infections
- Registration Number
- NCT00038480
- Brief Summary
The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants.
- Detailed Description
LPV/RTV has shown significant antiviral activity and tolerability in clinical trials in adults and children over 6 months of age. LPV/RTV has been approved by the FDA to treat older children and adults with HIV. Data for children under 6 months, however, have not been available. LPV/RTV has not been approved for infants less than 6 months old, and the appropriate dose for young infants is not known. Dosing guidelines are needed for young infants, most of whom are in the early stages of primary infection. This study will help identify an appropriate dose range of LPV/RTV and evaluate response to therapy in infants less than 6 months of age. The study will also evaluate whether early therapy allows normal development of the immune system.
Infants between 14 days and 6 months of age will receive LPV/RTV in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their physicians. Twelve-hour pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient reaches 12 months of age. Patients will undergo a physical exam, medical history assessment, and blood collection at selected study visits. Study visits will occur every 2 weeks for the first 8 weeks, then every 4 weeks until the end of the first year of the study. Study visits during the second year will be every 12 weeks until the end of the study. The parent or guardian will be contacted by phone every 6 weeks to monitor adverse drug effects. Participants between the ages of 6 weeks but less than 6 months old will be followed for 96 weeks after the enrollment of the last participant. Participants between the ages of 14 weeks but less than 6 weeks will be followed for 48 weeks after the enrollment of the last participant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Trough concentration of LPV and pharmacokinetic parameters Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96 Recurrent treatment-related Grade 3 and non-life threatening Grade 4 toxicity or single occurence of life-threatening Grade 4 toxicity Throughout study
- Secondary Outcome Measures
Name Time Method Suppression of viral load to less than 400 copies/ml and less than 50 copies/ml Study entry and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 36, 40, 48, 60, 72, 84, and 96 Change in CD4 and CD8 count and percentage from baseline. HIV-1 specific CD4 count and CD8 mediated and humoral responses Study entry and Weeks 12, 24, 36, 48, 60, 72, 84, and 96 Time to virologic failure Throughout study
Trial Locations
- Locations (17)
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Baltimore, Maryland, United States
Children's National Med. Ctr. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
SOM Federal University Minas Gerais Brazil NICHD CRS
🇧🇷Minas Gerais, Brazil
Children's Hosp. of Boston NICHD CRS
🇺🇸Boston, Massachusetts, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
St. Christopher's Hosp. for Children
🇺🇸Philadelphia, Pennsylvania, United States
USF - Tampa NICHD CRS
🇺🇸Tampa, Florida, United States
Univ. of Sao Paulo Brazil NICHD CRS
🇧🇷Sao Paulo, Brazil
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
🇺🇸Baltimore, Maryland, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
St. Jude/UTHSC CRS
🇺🇸Memphis, Tennessee, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
Baystate Health, Baystate Med. Ctr.
🇺🇸Springfield, Massachusetts, United States