CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Abacavir +6 moredrug
Likely dose
Abacavir 8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00234091
NCT00234091Phase 3Completed
CompareCT.gov

An Open Label, Randomized Study to Compare Antiretroviral Therapy (ART) Initiation When CD4 is Between 15% to 24% to ART Initiation When CD4 Falls Below 15% in Children With HIV Infection and Moderate Immune Suppression

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 6, 2005·Updated Dec 4, 2013

In Brief

A Phase 3 clinical trial evaluating Abacavir, Efavirenz, and 5 other interventions for HIV Infections. Completed, enrolled 300 participants across 9 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine when HIV infected children should begin taking anti-HIV medications in order to improve both patient quality of life and survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesCambodia, Thailand
CollaboratorsComprehensive International Program of Research on AIDS

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2005
Enrollment StartApr 1, 2006
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 20.7 years ago

Interventions

Abacavirdrug

8 mg/kg (up to 300 mg/dose) take orally twice daily

Efavirenzdrug

200 to 600 mg taken orally once daily

Lamivudinedrug

4 mg/kg (up to 150 mg/dose) taken orally twice daily

Lopinavir/Ritonavirdrug

230 mg/57.5 mg/m\^2 body surface area taken orally twice daily with food

Nelfinavirdrug

45-55 mg/kg taken orally twice daily with food

Nevirapinedrug

120 mg/m\^2 once daily for first 14 days, tehn 200 mg/m\^2 (up to 400 mg/day) twice daily

Zidovudinedrug

180-240 mg/m\^2 every 12 hours (up to 300 mg/dose)