Clinical Trials


Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: May 31, 2002
Last updated: May 17, 2012
Last Verified: May 2012
History of Changes


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.

Condition Intervention Phase
HIV Infections

Drug : Lopinavir/Ritonavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Lopinavir/Ritonavir in HIV-1 Infected Infants Less Than 6 Months of Age

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Trough concentration of LPV and pharmacokinetic parameters [ Time Frame: 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 [ Time Frame: Throughout study ]
Secondary Outcome Measures:
  • Change in CD4 and CD8 count and percentage from baseline. HIV-1 specific CD4 count and CD8 mediated and humoral responses [ Time Frame: Study entry and Weeks 12, 24, 36, 48, 60, 72, 84, and 96 ]
  • Time to virologic failure [ Time Frame: Throughout study ]
  • Suppression of viral load to less than 400 copies/ml and less than 50 copies/ml [ Time Frame: Study entry and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 36, 40, 48, 60, 72, 84, and 96 ]

Enrollment: 31
Study Completion Date: September 2007

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.



Ages Eligible for Study: up to 6 Months  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria

  • HIV infected
  • Viral load greater than 10,000 copies/ml within 30 days prior to study entry
  • Weigh more than 5.5 lbs at the time of enrollment
  • Agree to take 2 nucleoside reverse transcriptase inhibitors (NRTIs) in addition to LPV/RTV
  • Have consent of parent or guardian willing to provide signed informed consent and to have the infant followed at a PACTG site

  • Exclusion Criteria
  • Currently taking a nonnucleoside reverse transcriptase inhibitor or protease inhibitor (PI) while on study
  • Previously used LPV/RTV. Patients who were treated previously with other PIs are not excluded. Prior or concurrent maternal treatment with LPV/RTV is not excluded.
  • For patients less than 6 weeks old at time of enrollment, less than 34 weeks gestation at delivery OR for patients 6 or more weeks old at time of enrollment, less than 32 weeks gestation at delivery
  • Any laboratory toxicity of Grade 3 or greater. Hyperlipasemia of Grade 2 or higher is also excluded.
  • Newly diagnosed acute opportunistic or serious bacterial infection requiring therapy at the time of enrollment
  • Chemotherapy for active cancer
  • Certain medications
  • Any other clinically significant conditions, other than HIV infection, that would
interfere with the study

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00038480


United States, California
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609-1809
San Francisco, California, United States, 94143-0105
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80218-1088
United States, District of Columbia
Children's National Med. Ctr. Washington DC NICHD CRS
Washington, District of Columbia, United States
United States, Florida
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Tampa, Florida, United States
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 606143394
United States, Maryland
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hosp. of Boston NICHD CRS
Boston, Massachusetts, United States, 021155724
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
United States, New York
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States, 10457
United States, Pennsylvania
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States, 381052794
SOM Federal University Minas Gerais Brazil NICHD CRS
Minas Gerais, Brazil
Univ. of Sao Paulo Brazil NICHD CRS
Sao Paulo, Brazil
Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Study Chair: Ellen G. Chadwick, MD Children's Memorial Hospital, Division of Pediatric Infectious Diseases
Study Chair: Jorge Pinto, MD, DSc Escola de Medicine, Universidade Federal de Minas Gerais
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00038480   History of Changes  
Other Study ID Numbers: P1030  
  PACTG P1030  
Study First Received: May 31, 2002  
Last Updated: May 17, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:
HIV Infections
Lopinavir processed this data on March 27, 2020
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