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Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children

NCT00260078 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-11-09

No results posted yet for this study

Summary

Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.

Conditions

  • HIV Infections

Interventions

DRUG

Atazanavir

200 mg to 400 mg orally daily

DRUG

Darunavir

300 mg or 600 mg orally twice daily

DRUG

Efavirenz

Dosage dependent on participant

DRUG

Nevirapine

Dosage dependent on participant

DRUG

Ritonavir

50 mg or 100 mg orally twice daily

DRUG

Tenofovir disoproxil fumarate

300 mg orally daily

PROCEDURE

Pharmacokinetic Study

Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.

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

  • Jennifer King, PharmD · Department of Pharmacology and Toxicology, University of Alabama at Birmingham

  • Ram Yogev, MD · Section of Pediatrics and Maternal HIV Infection, Children's Memorial Hospital, Northwestern University Medical School

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States
  • 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 NCT00260078 on ClinicalTrials.gov