Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth

PHASE3CompletedINTERVENTIONAL
Enrollment

377

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

September 30, 2012

Study Completion Date

January 31, 2013

Conditions
HIV Infections
Interventions
DRUG

Abacavir sulfate

Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.

DRUG

Didanosine

Second Line Regimen: Either 100 mg/m\^2 or 120 mg/m\^2 taken orally twice daily. Dosage depends on age. Guidelines for switching from first line to second line therapy are available in the protocol.

DRUG

Efavirenz

Second Line Regimen: taken orally once daily. Dosage depends on weight. Guidelines for switching from first line to second line therapy are available in the protocol.

DRUG

Lamivudine

First Line Regimen: 4 mg/kg taken orally twice daily

DRUG

Lopinavir/Ritonavir

First Line Regimen: taken orally twice daily. Dosage depends on age and weight.

DRUG

Nevirapine

Second Line Regimen: 150 - 200 mg/m\^2 taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.

DRUG

Zidovudine

First Line Regimen: 240 mg/m\^2 taken orally twice daily

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00102960 - Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth | Biotech Hunter | Biotech Hunter