Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

December 31, 2011

Study Completion Date

July 31, 2013

Conditions
HIV Infections
Interventions
DRUG

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

"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)"

Trial Locations (17)

1425

Local Institution, Buenos Aires

Local Institution, Capital Federal

2092

Local Institution, Westdene

7505

Local Institution, Cape Town

9301

Local Institution, Bloemfontein

10330

Local Institution, Bangkok

10700

Local Institution, Bangkok

28019

Local Institution, Colima

44280

Local Institution, Guadalajara

44520

Local Institution, Guadalajara

58000

Local Institution, Morelia

64460

Local Institution, Monterrey

72000

Local Institution, Puebla City

78240

Local Institution, San Luis Potosí City

Unknown

Local Institution, Santiago de Cali

06720

Local Institution, Df

0816-00383

Local Institution, Panama City

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT00364793 - Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children | Biotech Hunter | Biotech Hunter