CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)drug
Likely dose
Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC) 720 mgfrom 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/NCT00364793
NCT00364793Phase 2Completed
CompareCT.gov

An Open-label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination With Didanosine and Emtricitabine in HIV-infected Infants and Children 3 Months to 6 Years of Age.

Bristol-Myers Squibb·interventional·Posted Aug 16, 2006·Updated Apr 29, 2014

In Brief

A Phase 2 clinical trial evaluating Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC) for HIV Infections. Completed, enrolled 56 participants across 17 sites in 6 countries.

Detailed Summary

The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Colombia, Mexico, Panama, South Africa, Thailand
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2006
Enrollment StartFeb 1, 2007
Primary CompletionDec 1, 2011
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.9 years ago

Interventions

Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)drug

Oral Solution, Capsules or Tablets, Oral, once daily Efavirenz (EFV) per weight-based dosing nomogram (max 720 mg) Didanosine (ddI) 240 mg/m2 (max 400 mg) Emtricitabine (FTC) 6 mg/kg (max 200 mg) Where EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer); Where EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first)