Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00038480

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

31

Expected to finish

2007-09-01

Last updated by the study team

2021-11-01

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Children's National Med. Ctr. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• USF - Tampa NICHD CRS — Tampa, Florida, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• Children's Hosp. of Boston NICHD CRS — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• Bronx-Lebanon Hosp. IMPAACT CRS — The Bronx, New York, United States
• St. Christopher's Hosp. for Children — Philadelphia, Pennsylvania, United States
• St. Jude/UTHSC CRS — Memphis, Tennessee, United States
• SOM Federal University Minas Gerais Brazil NICHD CRS — Minas Gerais, Brazil
• Univ. of Sao Paulo Brazil NICHD CRS — São Paulo, Brazil
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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