An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

November 30, 2002

Primary Completion Date

July 31, 2004

Study Completion Date

July 31, 2004

Conditions
HIV Infections
Interventions
DRUG

Emtricitabine

emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if \<30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if \>=7 to \<15kg; 10/2.5 mg/kg BID if \>=15 to \<=40 kg)

DRUG

Emtricitabine

emtricitabine (6 mg/kg QD, up to 200 mg QD capsule formulation or up to 240 mg QD using the oral solution) plus didanosine (240 mg/m2 up to 400 mg QD) plus efavirenz (up to 600 mg QD capsule formulation or up to 720 mg QD using the oral solution).

Trial Locations (2)

Unknown

Bucharest

Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT00642291 - An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects | Biotech Hunter | Biotech Hunter