Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children (NCT NCT00364793)

Last Updated: 2014-04-29

Results Overview

Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Week 2

Results posted on

2014-04-29

Participant Flow

This study initiated February 2007 and completed July 2013. All participants enrolled in countries where efavirenz (EFV) oral solution was not commercially available could remain on study until their 7th birthday or until they were able to swallow EFV capsules (whichever occurred first).

56 participants were enrolled but 19 were never treated. Reasons for not treating: 2 deaths, 1 lost to follow up, 6 other (not specified), 9 no longer met study criteria, 1 withdrew consent.

Participant milestones

Participant milestones
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Overall Study STARTED	15	10	4	8
Overall Study COMPLETED	7	5	0	5
Overall Study NOT COMPLETED	8	5	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Overall Study Adverse Event	2	0	0	0
Overall Study Death	1	0	1	0
Overall Study Lack of Efficacy	3	3	1	1
Overall Study Lost to Follow-up	1	0	2	0
Overall Study Poor or non-compliance	1	1	0	1
Overall Study No longer meets criteria	0	0	0	1
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total n=37 Participants Total of all reporting groups
Age, Continuous	0.392 years n=93 Participants	0.825 years n=4 Participants	2.313 years n=27 Participants	3.922 years n=483 Participants	0.663 years n=36 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	6 Participants n=483 Participants	13 Participants n=36 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	10 Participants n=4 Participants	3 Participants n=27 Participants	2 Participants n=483 Participants	24 Participants n=36 Participants
Race/Ethnicity, Customized White	3 participants n=93 Participants	9 participants n=4 Participants	4 participants n=27 Participants	8 participants n=483 Participants	24 participants n=36 Participants
Race/Ethnicity, Customized Black or African American	7 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	7 participants n=36 Participants
Race/Ethnicity, Customized Asian	2 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	2 participants n=36 Participants
Race/Ethnicity, Customized Other	3 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	4 participants n=36 Participants
Region of Enrollment Panama	3 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	1 participants n=483 Participants	4 participants n=36 Participants
Region of Enrollment Mexico	2 participants n=93 Participants	7 participants n=4 Participants	3 participants n=27 Participants	7 participants n=483 Participants	19 participants n=36 Participants
Region of Enrollment Argentina	0 participants n=93 Participants	3 participants n=4 Participants	1 participants n=27 Participants	0 participants n=483 Participants	4 participants n=36 Participants
Region of Enrollment Thailand	2 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	2 participants n=36 Participants
Region of Enrollment South Africa	7 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	7 participants n=36 Participants
Region of Enrollment Colombia	1 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	1 participants n=36 Participants
Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) Viral Load (log10 c/mL)	5.88 log10 c/mL n=93 Participants	5.88 log10 c/mL n=4 Participants	5.88 log10 c/mL n=27 Participants	5.26 log10 c/mL n=483 Participants	5.88 log10 c/mL n=36 Participants
HIV RNA Viral Load Category < 30,000 copies/mL	3 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	1 participants n=483 Participants	5 participants n=36 Participants
HIV RNA Viral Load Category 30,000 to <100,000 copies/mL	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants	2 participants n=483 Participants	4 participants n=36 Participants
HIV RNA Viral Load Category 100,000 to <500,000 copies/mL	2 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	2 participants n=483 Participants	5 participants n=36 Participants
HIV RNA Viral Load Category 500,000 to <=750,000 copies/mL	1 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	1 participants n=483 Participants	3 participants n=36 Participants
HIV RNA Viral Load Category >750,000 copies/mL	9 participants n=93 Participants	6 participants n=4 Participants	3 participants n=27 Participants	2 participants n=483 Participants	20 participants n=36 Participants
CD4 Cell Count (n=13, 9, 3, 7, 32)	1785 cells/mm^3 n=93 Participants	1569 cells/mm^3 n=4 Participants	517 cells/mm^3 n=27 Participants	540 cells/mm^3 n=483 Participants	1144 cells/mm^3 n=36 Participants

PRIMARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population Cmin	391 ng/mL Geometric Coefficient of Variation 141	445 ng/mL Geometric Coefficient of Variation 57	648 ng/mL Geometric Coefficient of Variation 75	1185 ng/mL Geometric Coefficient of Variation 111	—
Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population Cmax	3790 ng/mL Geometric Coefficient of Variation 76	1998 ng/mL Geometric Coefficient of Variation 51	2167 ng/mL Geometric Coefficient of Variation 68	2632 ng/mL Geometric Coefficient of Variation 83	—

PRIMARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was \< LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars\*time (µM•h).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
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	129.5 µM•h Geometric Coefficient of Variation 98	71.4 µM•h Geometric Coefficient of Variation 49	93.8 µM•h Geometric Coefficient of Variation 68	130.8 µM•h Geometric Coefficient of Variation 98	—

PRIMARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population	9.54 L/h Geometric Coefficient of Variation 63	19.69 L/h Geometric Coefficient of Variation 85	13.16 L/h Geometric Coefficient of Variation 58	9.11 L/h Geometric Coefficient of Variation 73	—

PRIMARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population	2.07 L/h/kg Geometric Coefficient of Variation 71	2.36 L/h/kg Geometric Coefficient of Variation 84	1.44 L/h/kg Geometric Coefficient of Variation 51	0.66 L/h/kg Geometric Coefficient of Variation 72	—

SECONDARY outcome

Timeframe: Week 48

Population: Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.

Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \< 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \< 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were \< 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA \< 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
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 VR-OC n=9, 9, 3, 6, 27	7 participants	6 participants	3 participants	5 participants	21 participants
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 SNAPSHOT n=15, 10, 4, 8, 37	7 participants	6 participants	3 participants	5 participants	21 participants
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 CVR (NC=F) n=15, 10, 4, 8, 37	7 participants	6 participants	3 participants	5 participants	21 participants

SECONDARY outcome

Timeframe: Week 48

Population: Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.

Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \< 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \< 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were \< 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA \< 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants CVR (NC=F) n=15, 10, 4, 8, 37	6 participants	6 participants	2 participants	4 participants	18 participants
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants VR-OC n=9, 9, 3, 6, 27	6 participants	5 participants	2 participants	4 participants	17 participants
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants SNAPSHOT n=15, 10, 4, 8, 37	6 participants	5 participants	2 participants	4 participants	17 participants

SECONDARY outcome

Timeframe: Week 24

Population: Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.

Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \< 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \< 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were \< 400 c/mL; denominator was all who remained on treatment through Week 24.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants CVR (n=15, 10, 4, 8, 37)	8 participants	7 participants	4 participants	7 participants	26 participants
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants VR-OC(n=11,10 ,4, 7, 32)	8 participants	7 participants	4 participants	6 participants	25 participants

SECONDARY outcome

Timeframe: Week 24

Population: Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.

Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA \< 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA \< 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were \< 50 c/mL; denominator was all who remained on treatment through Week 24.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants CVR (n=15, 10, 4, 8, 37)	4 participants	4 participants	3 participants	4 participants	15 participants
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants VR-OC (n=11, 10, 4, 7, 32)	5 participants	5 participants	2 participants	4 participants	16 participants

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.

HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=13 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=34 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Baseline (n=13,10,4,7,34)	5.88 log10 c/mL Interval 5.12 to 5.92	5.88 log10 c/mL Interval 5.32 to 5.88	5.88 log10 c/mL Interval 5.38 to 5.88	5.50 log10 c/mL Interval 4.64 to 5.88	5.88 log10 c/mL Interval 4.97 to 5.88
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 4 (n=11, 8, 4, 6, 29)	-2.18 log10 c/mL Inter-Quartile Range 0.372 • Interval -2.81 to -0.58	-2.49 log10 c/mL Inter-Quartile Range 0.308 • Interval -2.86 to -1.86	-2.86 log10 c/mL Inter-Quartile Range 0.160 • Interval -3.14 to -2.73	-3.04 log10 c/mL Inter-Quartile Range 0.343 • Interval -3.24 to -2.25	-2.63 log10 c/mL Inter-Quartile Range 0.195 • Interval -3.06 to -1.69
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 12 (n=10, 10, 3, 6, 29)	-2.48 log10 c/mL Inter-Quartile Range 0.541 • Interval -4.0 to -1.33	-3.19 log10 c/mL Inter-Quartile Range 0.431 • Interval -3.27 to -1.0	-4.02 log10 c/mL Inter-Quartile Range 0.310 • Interval -4.18 to -3.18	-3.31 log10 c/mL Inter-Quartile Range 0.362 • Interval -3.87 to -2.95	-3.14 log10 c/mL Inter-Quartile Range 0.261 • Interval -3.87 to -1.63
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 24 (n=10, 9, 3, 7, 29)	-3.46 log10 c/mL Inter-Quartile Range 0.610 • Interval -4.24 to -1.11	-3.92 log10 c/mL Inter-Quartile Range 0.525 • Interval -4.18 to -2.03	-4.18 log10 c/mL Inter-Quartile Range 0.585 • Interval -4.18 to -2.43	-2.95 log10 c/mL Inter-Quartile Range 0.372 • Interval -4.18 to -2.12	-3.28 log10 c/mL Inter-Quartile Range 0.278 • Interval -4.18 to -2.03
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 48 (n=9, 9, 3, 6, 27)	-2.92 log10 c/mL Inter-Quartile Range 0.551 • Interval -4.18 to -1.67	-3.27 log10 c/mL Inter-Quartile Range 0.469 • Interval -4.18 to -1.95	-3.27 log10 c/mL Inter-Quartile Range 0.320 • Interval -4.18 to -3.18	-2.93 log10 c/mL Inter-Quartile Range 0.622 • Interval -4.18 to -1.69	-3.18 log10 c/mL Inter-Quartile Range 0.271 • Interval -4.18 to -1.69
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 32 (n=9, 9, 4, 6, 28)	-2.75 log10 c/mL Inter-Quartile Range 0.547 • Interval -4.08 to -1.67	-3.28 log10 c/mL Inter-Quartile Range 0.506 • Interval -4.18 to -1.96	-3.73 log10 c/mL Inter-Quartile Range 0.276 • Interval -4.18 to -3.23	-2.93 log10 c/mL Inter-Quartile Range 0.461 • Interval -4.18 to -1.69	-3.27 log10 c/mL Inter-Quartile Range 0.259 • Interval -4.18 to -1.81
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 40 (n=7, 9, 4 ,6, 26)	-4.01 log10 c/mL Inter-Quartile Range 0.434 • Interval -4.24 to -1.94	-4.17 log10 c/mL Inter-Quartile Range 0.435 • Interval -4.18 to -3.28	-4.02 log10 c/mL Inter-Quartile Range 0.236 • Interval -4.18 to -3.52	-2.93 log10 c/mL Inter-Quartile Range 0.620 • Interval -4.18 to -0.87	-3.93 log10 c/mL Inter-Quartile Range 0.240 • Interval -4.18 to -2.9
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 2 (n=12, 9, 4, 5, 30)	-1.89 log10 c/mL Inter-Quartile Range 0.270 • Interval -2.6 to -0.93	-2.26 log10 c/mL Inter-Quartile Range 0.278 • Interval -2.32 to -1.73	-2.42 log10 c/mL Inter-Quartile Range 0.496 • Interval -3.38 to -2.11	-1.93 log10 c/mL Inter-Quartile Range 0.277 • Interval -2.49 to -1.85	-2.11 log10 c/mL Inter-Quartile Range 0.162 • Interval -2.51 to -1.36
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 8 (n=11, 10, 3, 7, 31)	-2.73 log10 c/mL Inter-Quartile Range 0.412 • Interval -3.48 to -0.76	-2.91 log10 c/mL Inter-Quartile Range 0.366 • Interval -3.27 to -1.54	-2.92 log10 c/mL Inter-Quartile Range 0.070 • Interval -3.12 to -2.9	-3.27 log10 c/mL Inter-Quartile Range 0.338 • Interval -4.05 to -2.59	-2.92 log10 c/mL Inter-Quartile Range 0.209 • Interval -3.33 to -1.69
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants Week 16 (n=10, 10, 4, 7, 31)	-2.72 log10 c/mL Inter-Quartile Range 0.527 • Interval -4.18 to -1.67	-3.17 log10 c/mL Inter-Quartile Range 0.496 • Interval -3.55 to -0.44	-4.11 log10 c/mL Inter-Quartile Range 0.240 • Interval -4.18 to -3.61	-3.44 log10 c/mL Inter-Quartile Range 0.326 • Interval -4.05 to -2.95	-3.27 log10 c/mL Inter-Quartile Range 0.253 • Interval -4.05 to -1.94

SECONDARY outcome

Timeframe: Baseline to Weeks 24 and 48

A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm\^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=9 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=6 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=28 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants Baseline (n=10, 9, 3, 6, 28)	1518 cells/mm^3 Interval 829.0 to 2202.0	1569 cells/mm^3 Interval 1149.0 to 2284.0	517 cells/mm^3 Interval 129.0 to 558.0	413 cells/mm^3 Interval 23.0 to 688.0	1144 cells/mm^3 Interval 529.0 to 1930.0
CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants Week 24 (n=6, 7, 3, 6, 22)	259 cells/mm^3 Inter-Quartile Range 410.8 • Interval -180.0 to 840.0	82 cells/mm^3 Inter-Quartile Range 330 • Interval -436.0 to 669.0	31 cells/mm^3 Inter-Quartile Range 818.3 • Interval 15.0 to 2478.0	283 cells/mm^3 Inter-Quartile Range 195.2 • Interval 146.0 to 452.0	177 cells/mm^3 Inter-Quartile Range 185.3 • Interval 15.0 to 669.0
CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants Week 48 (n=7, 8, 2, 5, 22)	-258 cells/mm^3 Inter-Quartile Range 401.5 • Interval -1313.0 to 606.0	346 cells/mm^3 Inter-Quartile Range 381.8 • Interval -622.0 to 846.0	971 cells/mm^3 Inter-Quartile Range 956.0 • Interval 15.0 to 1927.0	284 cells/mm^3 Inter-Quartile Range 296.8 • Interval 215.0 to 330.0	196 cells/mm^3 Inter-Quartile Range 220.8 • Interval -258.0 to 721.0

SECONDARY outcome

Timeframe: Baseline to Weeks 24 and 48

A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm\^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured\*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=9 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=5 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=24 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants Baseline (n=7, 9, 3, 5, 24)	28 percentage of CD4 cells Interval 17.0 to 40.0	26 percentage of CD4 cells Interval 25.0 to 28.0	12 percentage of CD4 cells Interval 5.0 to 20.0	7 percentage of CD4 cells Interval 2.0 to 23.0	24 percentage of CD4 cells Interval 14.0 to 28.0
Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants Week 48 (n=5, 8, 2, 5, 20)	5 percentage of CD4 cells Inter-Quartile Range 4.5 • Interval -2.0 to 7.0	4 percentage of CD4 cells Inter-Quartile Range 3.5 • Interval -4.0 to 11.0	8 percentage of CD4 cells Inter-Quartile Range 8.9 • Interval -1.0 to 17.0	11 percentage of CD4 cells Inter-Quartile Range 2.9 • Interval 9.0 to 12.0	6 percentage of CD4 cells Inter-Quartile Range 2.1 • Interval -1.0 to 13.0
Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants Week 24 (n=3, 7, 3, 5, 18)	14 percentage of CD4 cells Inter-Quartile Range 12.0 • Interval -19.0 to 19.0	2 percentage of CD4 cells Inter-Quartile Range 2.8 • Interval 0.0 to 14.0	9 percentage of CD4 cells Inter-Quartile Range 3.2 • Interval -1.0 to 9.0	10 percentage of CD4 cells Inter-Quartile Range 4.2 • Interval 9.0 to 16.0	9 percentage of CD4 cells Inter-Quartile Range 2.3 • Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: All categories except one analyzed treated participants, who received at least 1 dose of study drug (EFV). One category analyzed enrolled participants who were not treated and cannot be assigned to a group.

Center for Disease Control and Prevention (CDC) classification of Class C events used to define acquired immunodeficiency syndrome (AIDS): include pneumocystis pneumonia, pneumonia, pulmonary tuberculosis. AE=new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. AE Severity: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling (Division of AIDs Table, published December 2004). Baseline=within 50 days post screening, prior to start of study drug. 2 categories for death presented (on-treatment and enrolled/not treated).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
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 Deaths (Enrolled Participants, Not treated)	2 participants	0 participants	0 participants	0 participants	2 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 AE (All Grades,Treated Participants)	13 participants	9 participants	4 participants	6 participants	32 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 Grade 3 - 4 AEs (Treated Participants)	4 participants	2 participants	3 participants	1 participants	10 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 Related AE (All Grades,Treated Participants)	8 participants	5 participants	4 participants	4 participants	21 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 Death (Treated Participants)	1 participants	0 participants	1 participants	0 participants	2 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 SAE (Treated Participants)	8 participants	5 participants	4 participants	3 participants	20 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 Grade 2 - 4 AEs (Treated Participants)	11 participants	7 participants	4 participants	5 participants	27 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 Discontinued due to AE (Treated Participants)	2 participants	0 participants	0 participants	0 participants	2 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 CDC Class C AIDS event (Treated Participants)	1 participants	1 participants	0 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).

Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5\*ULN; Gr 2: 2.6 to 5.0\*ULN; Gr 3: 5.1 to 10.0\*ULN; Gr 4: \>10.0\*ULN. AST Gr 1: 1.25 to 2.5\*ULN; Gr 2: 2.6 to 5.0\*ULN; Gr 3: 5.1 to 10.0\*ULN; Gr 4: \>10.0\*ULN. Total bilirubin Gr 1: 1.25 to 1.5\*ULN; Gr 2: 1.6 to 2.5\*ULN; Gr 3: 2.6 to 5.0\*ULN; Gr 4: \>5.0\*ULN. ALP (U/L) Gr 1: 1.25 to 2.5\*ULN, Gr 2: 2.6 to 5.0\*ULN, Gr 3: 5.1 to 10.0\*ULN, Gr 4: \>10.0\*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to \<LLN ; Gr 2: 2.0-2.9 g/dL; Gr 3: \< 2 g/dL. Gr 4: Not applicable. Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population Albumin (n=12, 10, 4, 7, 33)	0 participants	0 participants	1 participants	0 participants	1 participants
Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population ALP (n=12, 10, 4, 7, 33)	8 participants	2 participants	2 participants	5 participants	17 participants
Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population AST (n=12, 10, 4, 7, 33)	8 participants	1 participants	1 participants	0 participants	10 participants
Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population ALT (n=12, 10, 4, 7, 33)	7 participants	3 participants	2 participants	0 participants	12 participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).

Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 \>300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 \>=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: \>1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: \>500 (\> 500) mg/dL. Glucose, serum, low, \>=1 month of age (\<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: \<30 (\<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants Glucose High (n=11,10,3,0,24)	1 participants	0 participants	0 participants	NA participants only fasting samples taken	1 participants
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants Glucose Low (n=11,10,3,0,24)	2 participants	1 participants	0 participants	NA participants only fasting samples taken	3 participants
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants Glucose High Fasting (n=0,0,0,7,7)	NA participants too young to fast, samples not taken	NA participants too young to fast, samples not taken	NA participants too young to fast, samples not taken	1 participants	1 participants
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants LDL cholesterol (n=9,10,4,0,23)	0 participants	4 participants	0 participants	NA participants only fasting samples taken	4 participants
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants Total Cholesterol (n=9,10,4,0,23)	2 participants	4 participants	1 participants	NA participants only fasting samples taken	7 participants
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants Total Cholesterol Fasting (n=0,0,0,7,7)	NA participants too young to fast, samples not taken	NA participants too young to fast, samples not taken	NA participants too young to fast, samples not taken	1 participants	1 participants
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants LDL cholesterol fasting (n=0,0,0,7,7)	NA participants too young to fast, samples not taken	NA participants too young to fast, samples not taken	NA participants too young to fast, samples not taken	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).

Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - \< LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: \<8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: \>13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: \<6.1 mg/dL; creatinine Gr1: 1.1-1.3\*ULN; Gr 2: 1.4-1.8\*ULN; Gr 3: 1.9-3.4\*ULN; Gr 4: \>=3.5\*ULN; lipase Gr 1: 1.1-1.5\*ULN; Gr 2: 1.6-3.0\*ULN; Gr 3: 3.1-5.0\*ULN; Gr 4: \>5.0\*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: \>7.0 (\<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: \>=160 (\<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: \>15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Sodium High (n=12, 10, 4, 7, 33)	1 participants	1 participants	0 participants	1 participants	3 participants
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Uric Acid (n=12, 10, 4, 7, 33)	0 participants	1 participants	1 participants	0 participants	2 participants
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Calcium High (n= 12, 10, 4, 7, 33)	0 participants	2 participants	0 participants	1 participants	3 participants
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Lipase Total (n= 12, 10, 4, 7, 33)	1 participants	0 participants	0 participants	2 participants	3 participants
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Bicarbonate, low (n=12, 10, 4, 7, 33)	10 participants	9 participants	4 participants	5 participants	28 participants
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Sodium, low (n=12, 10, 4, 7, 33)	5 participants	4 participants	2 participants	4 participants	15 participants
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Calcium Low (n= 12, 10, 4, 7, 33)	0 participants	4 participants	1 participants	1 participants	6 participants
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Potassium High (n= 12, 10, 4, 7, 33)	5 participants	4 participants	0 participants	0 participants	9 participants
Number of Participants With Serum Chemistry Abnormalities - Treated Participants Potassium Low (n= 12, 10, 4, 7, 33)	1 participants	0 participants	1 participants	1 participants	3 participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).

Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: \<6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999\*10\^9/L; Gr 2: 50.000-99.999\*10\^9/L; Gr 3: 25.000-49.999\*10\^9/L; Gr 4: \<25.000\*10\^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500\*10\^9/L; Gr 2: 1.500-1.999\*10\^9/L; Gr 3: 1.000-1.499\*10\^9/L; Gr 4: \<1.000\*10\^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Number of Participants With Hematologic Abnormalities - Treated Participants Hemoglobin (n=11, 10, 4, 7, 32)	4 participants	5 participants	2 participants	1 participants	12 participants
Number of Participants With Hematologic Abnormalities - Treated Participants Platelet (n=11, 10, 4, 7, 32)	1 participants	1 participants	0 participants	0 participants	2 participants
Number of Participants With Hematologic Abnormalities - Treated Participants Neutrophils (n=11, 10, 4, 7, 32)	7 participants	2 participants	0 participants	1 participants	10 participants

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Participants who met the definition of virologic failure per protocol (PP): n=6 ; in addition, those who rebounded on treatment with plasma HIV RNA \> 10,000 c/mL but samples were not obtained within specified 35 day limit were included (not PP): n=5; participants with virologic failure and with samples available for analysis of virus changes:n=11.

At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: \> 3.1\* the 50% inhibitory concentration (IC50) of the control strain; EFV: \> 3.3\* IC50 ; ddI: \> 2.6\*IC50. Virologic failure: \<1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA \> 10,000 c/mL with prior value \< 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=5 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=1 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=1 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=11 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound Lack of suppression with Changes (PP)	2 participants	1 participants	0 participants	0 participants	3 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 Viral Load Rebound with Changes(PP)	1 participants	1 participants	0 participants	0 participants	2 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 Viral Failure with Changes (outside 35 day limit)	0 participants	3 participants	1 participants	1 participants	5 participants

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles at Week 2 were analyzed. n=number of participants with AUC\<110 µM•h and number of participants with AUC\>=110 µM•h.

PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)\*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM\*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC\<110 μM\*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: \> 3.3\* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=12 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=33 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population Resistant; AUC>=110 µM•h(n=10,3,2,4,19)	2 participants	2 participants	0 participants	0 participants	4 participants
Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population Resistant; AUC<110 µM•h(n=2,7,2,3,14)	1 participants	3 participants	1 participants	1 participants	6 participants

SECONDARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were \<LLOQ in all age groups except \>=6 months to \< 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were \<LLOQ; LLOQ/2 was imputed for those samples for summary statistics. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=12 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=6 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population Cmax (n=12, 10, 4, 6)	850 ng/mL Geometric Coefficient of Variation 48	1193 ng/mL Geometric Coefficient of Variation 39	356 ng/mL Geometric Coefficient of Variation 69	376 ng/mL Geometric Coefficient of Variation 93	—
Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population Cmin (n=4, 10, 4, 3)	1.25 ng/mL Geometric Coefficient of Variation 0	1.54 ng/mL Geometric Coefficient of Variation 132	1.25 ng/mL Geometric Coefficient of Variation 0	1.25 ng/mL Geometric Coefficient of Variation 0	—

SECONDARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was \< LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms\*time per milliliter (ng•h/mL).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population	1445 ng•h/mL Geometric Coefficient of Variation 76	2848 ng•h/mL Geometric Coefficient of Variation 53	1038 ng•h/mL Geometric Coefficient of Variation 54	1000 ng•h/mL Geometric Coefficient of Variation 41	—

SECONDARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population	40.7 L/h Geometric Coefficient of Variation 110	35.6 L/h Geometric Coefficient of Variation 42	113.9 L/h Geometric Coefficient of Variation 111	143.0 L/h Geometric Coefficient of Variation 53	—

SECONDARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population	7.88 L/h/kg Geometric Coefficient of Variation 85	4.26 L/h/kg Geometric Coefficient of Variation 30	11.36 L/h/kg Geometric Coefficient of Variation 116	10.34 L/h/kg Geometric Coefficient of Variation 70	—

SECONDARY outcome

Timeframe: Week 2

Population: All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population	0.92 h Standard Deviation 0.1374	1.41 h Standard Deviation 0.859	1.73 h Standard Deviation 1.007	1.14 h Standard Deviation 0.214	—

SECONDARY outcome

Timeframe: Weeks 60, 72, 84, and 96

Population: Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.

Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA \< 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were \< 400 c/mL; denominator was all who remained on treatment through the specific week.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants Week 60 (n=7, 8, 3, 4, 22)	7 participants	6 participants	2 participants	4 participants	19 participants
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants Week 72 (n=7, 7, 2, 4, 20)	7 participants	5 participants	1 participants	4 participants	17 participants
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants Week 84 (n=7, 7, 2, 4, 20)	7 participants	5 participants	1 participants	4 participants	17 participants
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants Week 96 (n=7, 6, 2, 4, 19)	7 participants	5 participants	1 participants	4 participants	17 participants

SECONDARY outcome

Timeframe: Weeks 60, 72, 84, and 96

Population: Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.

Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA \< 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were \< 50 c/mL; denominator was all who remained on treatment through the specific week.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=15 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=8 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=37 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants Week 84 (n=7, 7, 2, 4, 20)	7 participants	5 participants	1 participants	3 participants	16 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 Week 60 (n=7, 8, 3, 4, 22)	4 participants	5 participants	2 participants	3 participants	14 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 Week 72 (n=7, 7, 2, 4, 20)	7 participants	5 participants	1 participants	4 participants	17 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 Week 96 (n=7, 6, 2, 4, 19)	6 participants	5 participants	0 participants	4 participants	15 participants

SECONDARY outcome

Timeframe: Baseline through Weeks 60, 72, 84, and 96

Population: Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=13 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=4 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=34 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants Baseline (n=13,10,4,7,34)	5.88 log10 c/mL Interval 5.12 to 5.92	5.88 log10 c/mL Interval 5.32 to 5.88	5.88 log10 c/mL Interval 5.38 to 5.88	5.50 log10 c/mL Interval 4.64 to 5.88	5.88 log10 c/mL Interval 4.97 to 5.88
Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants Week 72 (n=7, 6, 1, 3, 17)	-4.08 log10 c/mL Inter-Quartile Range 0.438 • Interval -4.24 to -1.94	-2.75 log10 c/mL Inter-Quartile Range 0.603 • Interval -418.0 to -1.83	-3.20 log10 c/mL Inter-Quartile Range NA • Interval -3.2 to -3.2	-4.18 log10 c/mL Inter-Quartile Range 0.410 • Interval -4.18 to -2.95	-3.45 log10 c/mL Inter-Quartile Range 0.290 • Interval -4.18 to -2.21
Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants Week 84 (n=7, 7, 2, 4, 20)	-4.08 log10 c/mL Inter-Quartile Range 0.438 • Interval -4.24 to -1.94	-3.28 log10 c/mL Inter-Quartile Range 0.563 • Interval -4.18 to -1.54	-2.18 log10 c/mL Inter-Quartile Range 1.022 • Interval -3.2 to -1.16	-3.51 log10 c/mL Inter-Quartile Range 0.583 • Interval -4.13 to 2.32	-3.37 log10 c/mL Inter-Quartile Range 0.283 • Interval -4.18 to -1.81
Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants Week 96 (n=7, 6, 2, 4, 19)	-3.82 log10 c/mL Inter-Quartile Range 0.423 • Interval -4.18 to -1.94	-3.73 log10 c/mL Inter-Quartile Range 0.686 • Interval -4.18 to -1.19	-2.15 log10 c/mL Inter-Quartile Range 0.848 • Interval -2.99 to -1.3	-3.57 log10 c/mL Inter-Quartile Range 0.597 • Interval -4.18 to -2.32	-3.45 log10 c/mL Inter-Quartile Range 0.296 • Interval -4.18 to -1.69
Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants Week 60 (n=7, 8, 3, 4, 22)	-3.92 log10 c/mL Inter-Quartile Range 0.458 • Interval -418.0 to -1.94	-3.44 log10 c/mL Inter-Quartile Range 0.539 • Interval -4.18 to -1.46	-3.26 log10 c/mL Inter-Quartile Range 0.322 • Interval -4.18 to -3.18	-3.48 log10 c/mL Inter-Quartile Range 0.575 • Interval -4.1 to -2.32	-3.50 log10 c/mL Inter-Quartile Range 0.259 • Interval -4.18 to -1.94

SECONDARY outcome

Timeframe: Baseline to Weeks 60, 72, 84, and 96

Population: Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=10 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=9 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=6 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=28 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Baseline (n=10,9,3,6,28)	1518 cells/mm^3 Interval 829.0 to 2202.0	1569 cells/mm^3 Interval 1149.0 to 2284.0	517 cells/mm^3 Interval 129.0 to 558.0	413 cells/mm^3 Interval 23.0 to 688.0	1144 cells/mm^3 Interval 529.0 to 1930.0
CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Week 60 (n=6, 6, 2,3,17)	-870 cells/mm^3 Interval -1331.0 to -315.0	-914 cells/mm^3 Interval -1509.0 to 725.0	580 cells/mm^3 Interval -11.0 to 1171.0	676 cells/mm^3 Interval 506.0 to 887.0	-315 cells/mm^3 Interval -1331.0 to 676.0
CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Week 72 (n=5, 7, 1, 3, 16)	-1178 cells/mm^3 Interval -1422.0 to -588.0	234 cells/mm^3 Interval -1540.0 to 624.0	-50 cells/mm^3 Interval -50.0 to -50.0	620 cells/mm^3 Interval 619.0 to 811.0	92 cells/mm^3 Interval -1300.0 to 620.0
CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Week 84 (n=6, 7, 1, 3, 17)	-937 cells/mm^3 Interval -1331.0 to -155.0	59 cells/mm^3 Interval -1416.0 to 316.0	101 cells/mm^3 Interval 101.0 to 101.0	497 cells/mm^3 Interval 339.0 to 722.0	59 cells/mm^3 Interval -1304.0 to 334.0
CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Week 96 (n=6, 6, 1, 3, 16)	-834 cells/mm^3 Interval -1437.0 to -176.0	-43 cells/mm^3 Interval -1291.0 to 222.0	402 cells/mm^3 Interval 402.0 to 402.0	744 cells/mm^3 Interval 295.0 to 1243.0	-40 cells/mm^3 Interval -1185.0 to 314.0

SECONDARY outcome

Timeframe: Baseline to Weeks 60, 72, 84, and 96

Population: Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.

A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm\^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured\*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).

Outcome measures

Outcome measures
Measure	EFV+ddI+FTC in Infants >=3 Months to < 6 Months n=7 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Infants >=6 Months to < 2 Years n=9 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 2 Years to < 3 Years n=3 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	EFV+ddI+FTC in Children >= 3 Years to <= 6 Years n=5 Participants EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.	Total Participants n=24 Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Week 84 (n=3,7,1,3,14)	-3 percentage of CD4 cells Interval -22.0 to 21.0	8 percentage of CD4 cells Interval 0.0 to 11.0	2 percentage of CD4 cells Interval 2.0 to 2.0	12 percentage of CD4 cells Interval 5.0 to 34.0	7 percentage of CD4 cells Interval 0.0 to 12.0
Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Week 60 (n=3,6,2,3,14)	10 percentage of CD4 cells Interval -9.0 to 13.0	3 percentage of CD4 cells Interval -5.0 to 5.0	7 percentage of CD4 cells Interval -1.0 to 15.0	13 percentage of CD4 cells Interval 9.0 to 26.0	7 percentage of CD4 cells Interval -1.0 to 13.0
Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Week 72 (n=2,7,1,3,13)	-14 percentage of CD4 cells Interval -17.0 to -10.0	1 percentage of CD4 cells Interval -5.0 to 13.0	-1 percentage of CD4 cells Interval -1.0 to -1.0	12 percentage of CD4 cells Interval 11.0 to 26.0	1 percentage of CD4 cells Interval -5.0 to 12.0
Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Week 96 (n=3,6,1,3,13)	-2 percentage of CD4 cells Interval -19.0 to 6.0	7 percentage of CD4 cells Interval 3.0 to 10.0	15 percentage of CD4 cells Interval 15.0 to 15.0	14 percentage of CD4 cells Interval 14.0 to 28.0	7 percentage of CD4 cells Interval 3.0 to 14.0
Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants Baseline (n=7,9,3,5,24)	28 percentage of CD4 cells Interval 17.0 to 40.0	26 percentage of CD4 cells Interval 25.0 to 28.0	12 percentage of CD4 cells Interval 5.0 to 20.0	7 percentage of CD4 cells Interval 2.0 to 23.0	24 percentage of CD4 cells Interval 14.0 to 28.0

Adverse Events

EFV+ddI+FTC in All Participants

Serious events: 20 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EFV+ddI+FTC in All Participants n=37 participants at risk All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Skin and subcutaneous tissue disorders Eczema	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Oral herpes	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Bacterial infection	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Bronchiolitis	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Nervous system disorders Epilepsy	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Appendicitis perforated	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Bovine tuberculosis	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Mastoiditis	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Varicella	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Viral rash	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Nervous system disorders Febrile convulsion	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Pneumonia	21.6% 8/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	8.1% 3/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
General disorders Mass	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Otitis media	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Impetigo	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Lymph node tuberculosis	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Pneumocystis jiroveci pneumonia	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal perforation	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Oral candidiasis	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Respiratory syncytial virus bronchiolitis	2.7% 1/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	EFV+ddI+FTC in All Participants n=37 participants at risk All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Gastrointestinal disorders Abdominal pain	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Acarodermatitis	8.1% 3/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	13.5% 5/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis	10.8% 4/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis atopic	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Papule	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	18.9% 7/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Bronchitis	13.5% 5/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Head injury	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Investigations Lymph node palpable	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	35.1% 13/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Pharyngotonsillitis	10.8% 4/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Prurigo	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
General disorders Pyrexia	24.3% 9/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin exfoliation	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Viral rhinitis	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Candida nappy rash	13.5% 5/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis diaper	13.5% 5/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatosis	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Mastoiditis	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Otitis media acute	10.8% 4/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Pharyngitis	27.0% 10/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Sinusitis	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Gastrointestinal disorders Steatorrhoea	8.1% 3/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Varicella	8.1% 3/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	8.1% 3/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Gastrointestinal disorders Dental caries	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Influenza	16.2% 6/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Rhinitis	16.2% 6/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.1% 3/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	10.8% 4/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Tonsillitis	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	18.9% 7/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Pneumonia	10.8% 4/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	51.4% 19/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	18.9% 7/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Otitis media	18.9% 7/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Eye disorders Conjunctivitis	10.8% 4/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	10.8% 4/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Ear infection	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Impetigo	13.5% 5/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	8.1% 3/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Otitis media chronic	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Oral candidiasis	8.1% 3/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Otitis externa	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
General disorders Product taste abnormal	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	5.4% 2/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	27.0% 10/37 • 96 Weeks (Last patient, last visit). Participants who received at least one dose of study drug.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER