CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 266 enrolled
Drug / intervention
NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT) +2 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age older than 30 days and younger than 18 years (up to the day before 18th birthday)
  • ✓Confirmed HIV-1 infection
  • ✓Antiretroviral-naive or received anti-HIV drugs for less than 56 consecutive days after birth for PMTCT prevention
Key exclusion· 7
  • ✕Grade 3 or 4 clinical or laboratory toxicity
  • ✕Active opportunistic infection or serious bacterial infection at study entry
  • ✕Pancreatic, nervous system, blood, liver, or kidney dysfunction that precludes study medication administration
  • ✕Concurrent medications that cannot be combined with first-line study regimens

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00039741
NCT00039741Phase 3Completed
CompareCT.gov

A Phase II/III Randomized, Open-Label Study of Combination Antiretroviral Regimens and Treatment-Switching Strategies in HIV-1-Infected Antiretroviral Naive Children Between 30 Days and 18 Years of Age

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 11, 2002·Updated Nov 5, 2021

In Brief

A Phase 3 clinical trial evaluating NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT), NNRTIs (EFV, NVP), and 1 other intervention for HIV Infections. Completed, enrolled 266 participants across 31 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), PENTA Foundation

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2002
Enrollment StartAug 1, 2002
Primary CompletionAug 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 24.1 years ago

Interventions

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

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

NNRTIs (EFV, NVP)drug

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

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

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