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Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

NCT00038480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-11-01

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Lopinavir/Ritonavir

Sponsors & Collaborators

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

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ellen G. Chadwick, MD · Children's Memorial Hospital, Division of Pediatric Infectious Diseases

  • Jorge Pinto, MD, DSc · Escola de Medicine, Universidade Federal de Minas Gerais

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Days
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2007-09-30

Countries

  • United States
  • Brazil
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00038480 on ClinicalTrials.gov