Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I/II Study of Lopinavir/Ritonavir in HIV-1 Infected Infants Less Than 6 Months of Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Trough concentration of LPV and pharmacokinetic parameters
Time Frame: Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96
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
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Study entry and Weeks 12, 24, 36, 48, 60, 72, 84, and 96
Time to virologic failure
Time Frame: Throughout study
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
Study entry and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 36, 40, 48, 60, 72, 84, and 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

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

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 31, 2002

First Submitted That Met QC Criteria

May 31, 2002

First Posted (Estimate)

June 3, 2002

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1030
  • 10041 (Registry Identifier: DAIDS ES)
  • PACTG P1030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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