A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.

PHASE1CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
HIV Infections
Interventions
DRUG

Nevirapine Immediate Release (IR)

200 mg Tablet or 50 mg / 5 ml oral suspension

DRUG

Nevirapine Extended Release (XR)

200 mg, 300 mg or 400 mg Tablet formulation

Trial Locations (10)

Unknown

1100.1518.0001 Boehringer Ingelheim Investigational Site, Washington D.C.

1100.1518.0002 Boehringer Ingelheim Investigational Site, Philadelphia

1100.1518.2605 Boehringer Ingelheim Investigational Site, Francistown

1100.1518.2601 Boehringer Ingelheim Investigational Site, Gaborone

1100.1518.2603 Boehringer Ingelheim Investigational Site, Gaborone

1100.1518.4902 Boehringer Ingelheim Investigational Site, Berlin

1100.1518.4901 Boehringer Ingelheim Investigational Site, Frankfurt am Main

1100.1518.4903 Boehringer Ingelheim Investigational Site, München

1100.1518.2702 Boehringer Ingelheim Investigational Site, Cape Town

1100.1518.2703 Boehringer Ingelheim Investigational Site, Parow Valley

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY