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.

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

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

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

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

Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population

Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population

Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population

Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population

The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants

The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants

The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants

The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants

Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants

CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants

Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants

Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events

Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population

Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants

Number of Participants With Serum Chemistry Abnormalities - Treated Participants

Number of Participants With Hematologic Abnormalities - Treated Participants

Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound

Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population

Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population

The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants

The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants

Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants

CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants

Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants