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IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults

NCT00977756 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2015-08-07

No results posted yet for this study

Summary

This study will examine drug and body interactions in children receiving anti-HIV treatment regimens using new medications. Drug regimens to be examined will feature the medications raltegravir (RAL), maraviroc (MVC), and etravirine (ETV). These drugs will not be provided through the study.

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir (RAL)

400 mg twice daily (BID)

DRUG

Atazanavir (ATV)

300 mg daily

DRUG

Ritonavir (RTV)

100 mg daily, dosing by weight in Group I

DRUG

Tenofovir (TDF)

300 mg daily

DRUG

Etravirine (ETV)

200 mg BID

DRUG

Darunavir (DRV)

Dosing by weight

DRUG

Maraviroc (MVC)

150 mg BID in groups J and K; 600 mg BID in group L

DRUG

Lopinavir/ritonavir (LPV/r)

Coformulation of 400 mg lopinavir and 100 mg ritonavir, taken twice daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Jennifer R. King, PharmD · University of Alabama at Birmingham

  • Ram Yogev, MD · Northwestern University Feinberg School of Medicine

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2014-03-31
Completion
2014-03-31

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 NCT00977756 on ClinicalTrials.gov