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Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children

NCT00039741 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2021-11-05

Study results available
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Summary

Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe.

Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.

Conditions

  • HIV Infections

Interventions

DRUG

NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT)

Accepted NRTIs: abacavir sulfate (ABC), emtricitabine (FTC), emtricitabine/Tenofovir disoproxil fumarate (FTC/TDF), lamivudine (3TC), lamivudine/zidovudine (3TC/AZT), stavudine (d4T), tenofovir disoproxil fumarate (TDF), zalcitabine (ddC), zidovudine (AZT) Prescribed per participant's doctor

DRUG

NNRTIs (EFV, NVP)

Accepted NNRTIs: efavirenz (EFV), nevirapine (NVP) Prescribed per participant's doctor

DRUG

PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)

Accepted PIs: amprenavir (APV). indinavir sulfate (IDV), lopinavir/ritonavir (LPV/r), nelfinavir mesylate (NFV), saquinavir (SQV), ritonavir (RTV) Prescribed per participant's doctor

Sponsors & Collaborators

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

    collaborator NIH

  • PENTA Foundation

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ross E. McKinney, Jr., MD · Duke University

  • Ann J. Melvin, MD · Division of Infectious Diseases, Children's Hospital and Medical Center, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
30 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2009-08-31
Completion
2010-03-31

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 NCT00039741 on ClinicalTrials.gov