Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infecte... | NCT00326716

Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infecte... | NCT00326716 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Treatment	Experimental		Drug: Atazanavir + Ritonavir + Combivir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atazanavir + Ritonavir + Combivir	Drug	Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infant Gestational Age at Delivery		At the time of delivery
Infant Gender		At the time of delivery
Infant Race		At the time of delivery
Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval	Cmax = maximum observed plasma concentration of atazanavir at specified time points.	Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval	Cmax = maximum observed plasma concentration of ritonavir at specified time points.	Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Mean ATV Area Under the Concentration Curve (AUC TAU)	AUC = area under the concentration curve (AUC [TAU]) of atazanavir in one dosing interval from time zero to 24 hours.	Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Mean RTV Area Under the Concentration Curve (AUC TAU)	AUC = area under the concentration curve (AUC [TAU]) of ritonavir in one dosing interval.	Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose	Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.

Secondary Outcomes

Measure	Description	Time Frame
Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery	The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.	Day of Delivery ± 2 Days
Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Triple O Medical Services, P.A.		West Palm Beach	Florida	33401	United States
Women's Hospital Of Texas

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25529885	Derived	Xu XS, Rose A, Demers R, Eley T, Ryan J, Stouffer B, Cojocaru L, Arnold M. Quantitative determination of free/bound atazanavir via high-throughput equilibrium dialysis and LC-MS/MS, and the application in ex vivo samples. Bioanalysis. 2014;6(23):3169-82. doi: 10.4155/bio.14.251.
23782005	Derived	Eley T, Huang SP, Conradie F, Zorrilla CD, Josipovic D, Botes M, Osiyemi O, Hardy H, Bertz R, McGrath D. Clinical and pharmacogenetic factors affecting neonatal bilirubinemia following atazanavir treatment of mothers during pregnancy. AIDS Res Hum Retroviruses. 2013 Oct;29(10):1287-92. doi: 10.1089/AID.2013.0002. Epub 2013 Jul 19.

Arm/Group Information

ID	Title	Description
FG000	Mother ATV 300 mg / RTV 100 mg	Mothers receiving atazanavir (ATV) / ritonavir (RTV) 300/100 mg once daily (QD) + lamivudine (ZDV) / zidovudine (3TC) 300/150 mg twice daily (BID) during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
FG001	Mother ATV 400 mg / RTV 100 mg	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
FG002	Infants ATV 300 mg / RTV 100 mg	Infants born to mothers receiving treatment with ATV 300 mg / RTV 100 mg during the third trimester of pregnancy.
FG003	Infants ATV 400 mg / RTV 100 mg	Infants born to mothers receiving treatment with ATV 400 mg / RTV 100 mg during the third trimester of pregnancy.

Periods

Title

Milestones

Reasons Not Completed

Pre-Natal Mothers

Type	Comment	Milestone Data
STARTED		FG00020 subjects FG00121 subjects FG0020 subjects FG0030 subjects
COMPLETED		FG00019 subjectsCompletion was defined as completing the study. FG00119 subjectsCompletion was defined as completing the study. FG0020 subjectsCompletion was defined as completing all follow up visits through 6 months. FG003
NOT COMPLETED		FG0001 subjects FG0012 subjects FG0020 subjects FG0030 subjects

Type	Comment	Reasons
Discontinued ATV Before Delivery		FG0001 subjects FG0012 subjects FG0020 subjects FG003

Infants

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG00220 subjectsAll infants were followed. FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Mother ATV 300 mg / RTV 100 mg	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
BG001

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery

The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.

The analysis for the proportion of HIV RNA < 400 and < 50 c/mL at delivery is based on the Virologic Response - Observed Cases (VR-OC). VR-OC classifies subjects who remain on study therapy as responders according to a single HIV RNA measurement < 400 c/mL (or < 50 c/mL) closest to delivery and within delivery date ± 2 days.

Posted

Number

Participants

Day of Delivery ± 2 Days

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Infant ATV 300 mg / RTV 100 mg	Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
TRANSAMINASES INCREASED	Investigations	MedDRA 12.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
CONJUNCTIVITIS	Eye disorders	MedDRA 12.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
BMS Study Director	Bristol-Myers Squibb			clinical.trials@bms.com

Condition Browse Module

ID	Term
D015658	HIV Infections

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Intervention Browse Module

ID	Term
D000069446	Atazanavir Sulfate
D019438	Ritonavir
C109078	lamivudine, zidovudine drug combination

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009842	Oligopeptides

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG00017 BG00119 BG00236
White	BG0003 BG0011 BG0024
More than one race	BG0000 BG0011 BG0021
Unknown or Not Reported	BG0000 BG0010 BG0020

HIV RNA Distribution at Baseline

Number

c/mL

Title

Denominators

Categories

<50

Title	Measurements
	BG0003 BG0011 BG0024

50 to < 30,000

Title	Measurements
	BG00013 BG00113 BG00226

30,000 to < 100,000

Title	Measurements
	BG0003 BG0016 BG0029

>= 100,000

Title	Measurements
	BG0001 BG0011 BG0022

Secondary

Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level

The maternal HIV RNA level was determined at baseline and the day of delivery ± 2 days using VR-OC. The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.

The median maternal HIV RNA Level Change From Baseline was calculated for all treated mothers at the time of delivery. The maternal HIV RNA level at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.

Posted

Median

Inter-Quartile Range

log10 c / mL

Baseline, Day of Delivery ± 2 Days

ID	Title	Description
OG000	Mother ATV 300 mg / RTV 100 mg	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mother ATV 400 mg / RTV 100 mg	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00018 OG00119

Title

Denominators

Categories

Title	Measurements
	OG000-1.8(-2.43 to -1.39) OG001-2.37(-2.93 to -1.81)

Secondary

Mean HIV RNA Level at Baseline

All treated participants.

Posted

Mean

Standard Error

log10 cm / mL

Baseline

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 400 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00121

Title

Denominators

Categories

Title	Measurements
	OG0003.520± 0.232 OG0014.020± 0.171

Secondary

Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count

The median CD4 cell count change from baseline was calculated for all treated mothers at the time of delivery ± 2 days. Maternal CD4 cell counts were assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.

The median CD4 Cell Count Change From Baseline was calculated based on all treated mothers. The maternal CD4 cell count at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.

Posted

Median

Inter-Quartile Range

cells / mm^3

Baseline, Day of Delivery ± 2 Days

ID	Title	Description
OG000	Mother ATV 300 mg / RTV 100 mg	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mother ATV 400 mg / RTV 100 mg	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00017 OG00120

Title

Denominators

Categories

Title	Measurements
	OG00089(-75 to 213) OG001174(-39 to 257)

Secondary

Mean CD4 Cell Count at Baseline

All treated participants.

Posted

Mean

Standard Error

cells / mm^3

Baseline

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 400 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00121

Title

Denominators

Categories

Title	Measurements
	OG000435.0± 39.2 OG001390.0± 25.0

Secondary

Infant HIV Status

The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems).

All infants.

Posted

Number

Participants

Birth Through 6 Months on Study

ID	Title	Description
OG000	Infant ATV 300 mg / RTV 100 mg
OG001	Infant ATV 400 mg / RTV 100 mg

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

HIV Positive

Title	Measurements
	OG0000 OG0010

HIV Negative

Title	Measurements
	OG000

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE =any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.

The number of SAEs is based on enrolled participants. Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants.

Posted

Number

Participants

During study period and 30 days post-study.

ID	Title	Description
OG000	All Treated Mothers	Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
OG001	All Infants	Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.

Units	Counts
Participants	OG00041 OG00140

Title

Denominators

Categories

Death (n=41, n=40)

Title	Measurements
	OG0000 OG0010

Serious Adverse Event (n=41, n=40)

Title	Measurements
	OG000

Secondary

Number of Participants With Grade 2 to Grade 4 AEs and SAEs

AEs and SAEs considered possibly, probably, or certainly related to study treatment, were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). Hyperbilirubinemia (Grade 1=1.1 to 1.5 upper limit of normal [ULN] [mild], Grade 2=1.6 to 2.5 ULN [moderate], Grade 3=2.6 to 5.0 ULN [severe], Grade 4= > 5.0 ULN [potentially life threatening]).

Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants. The number of AEs and SAEs is based on enrolled participants.

Posted

Number

Participants

During Study Period and 30 Days Post-Study.

ID	Title	Description
OG000	All Treated Mothers	Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
OG001	All Infants	Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.

Units	Counts
Participants	OG00041 OG00140

Title

Denominators

Categories

Grade 2 to Grade 4 (n=41, n=40)

Title	Measurements
	OG00032 OG00119

Related Grade 2 to Grade 4 (n=41, n=40)

Title	Measurements
	OG000

Secondary

SAEs in Enrolled Mothers

SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.

Data were analyzed for all treated and untreated mothers.

Posted

Number

Participants

During Study Period and 30 Days Post-Study.

ID	Title	Description
OG000	Mother ATV 300 mg / RTV 100 mg	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mother ATV 400 mg / RTV 100 mg	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00121

Title

Denominators

Categories

Any Adverse Experience

Title	Measurements
	OG0007 OG0018

Blood and Lymphatic System Disorders

Title	Measurements
	OG000

Secondary

SAEs in Enrolled Infants

SAEs were recorded for all enrolled infants.

Posted

Number

Participants

Birth Through Week 16 of Life

ID	Title	Description
OG000	Infant ATV 300 mg / RTV 100 mg	Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
OG001	Infant ATV 400 mg / RTV 100 mg	Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Any Adverse Experience

Title	Measurements
	OG00010 OG0014

Blood and Lymphatic System Disorders

Title	Measurements
	OG000

Primary

Infant Gestational Age at Delivery

All infants.

Posted

Mean

Standard Error

Weeks

At the time of delivery

ID	Title	Description
OG000	Mothers ATV 300 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 400 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Title	Measurements
	OG00038± 0.3 OG00138± 0.3

Primary

Infant Gender

All infants.

Posted

Number

Participants

At the time of delivery

ID	Title	Description
OG000	Mothers ATV 300 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 400 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Male

Title	Measurements
	OG00012 OG0019

Female

Title	Measurements
	OG000

Primary

Infant Race

All infants.

Posted

Number

Participants

At the time of delivery

ID	Title	Description
OG000	Mothers ATV 300 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 400 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Black

Title	Measurements
	OG00015 OG00118

White

Title	Measurements
	OG000

Primary

Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval

Cmax = maximum observed plasma concentration of atazanavir at specified time points.

Treated participants in the pharmacokinetic (PK) concentration data set.

Posted

Geometric Mean

95% Confidence Interval

ng / mL

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG0003,729.09(2,744.17 to 5,067.52) OG0013,291.46(2,444.82 to 4,431.30) OG0024,210.76(3,369.46 to 5,262.11)

Primary

Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval

Cmax = maximum observed plasma concentration of ritonavir at specified time points.

Treated participants in the PK concentration data set.

Posted

Geometric Mean

95% Confidence Interval

ng / mL

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG000530.81(333.20 to 845.61) OG001587.36(423.55 to 814.52) OG002524.48(368.76 to 745.95)

Primary

Mean ATV Area Under the Concentration Curve (AUC TAU)

AUC = area under the concentration curve (AUC [TAU]) of atazanavir in one dosing interval from time zero to 24 hours.

Treated participants in the PK concentration data set.

Posted

Geometric Mean

95% Confidence Interval

ng•h / mL

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG00034,399.13(25,975.68 to 45,554.15) OG00134,251.50(27,173.69 to 43,172.84) OG00246,602.45(36,445.75 to 59,589.63)

Primary

Mean RTV Area Under the Concentration Curve (AUC TAU)

AUC = area under the concentration curve (AUC [TAU]) of ritonavir in one dosing interval.

Treated participants in the PK concentration data set.

Posted

Geometric Mean

95% Confidence Interval

ng•h / mL

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG0004,500.03(3,243.97 to 6,242.43) OG0014,664.93(3,670.14 to 5,929.35) OG0024,383.30(3,107.41 to 6,183.06)

Primary

Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose

Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.

Treated participants in the PK concentration data set.

Posted

Geometric Mean

95% Confidence Interval

ng•h / mL

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG000663.78(492.65 to 894.35) OG001668.48(529.06 to 844.64) OG002916.63(665.77 to 1,262.02)

Primary

Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose

Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.

Treated participants in the PK concentration data set.

Posted

Geometric Mean

95% Confidence Interval

ng•h / mL

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / RTV 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG00050.10(28.39 to 88.43) OG00141.12(29.06 to 58.21) OG00238.05(26.24 to 55.17)

Primary

Mean ATV Terminal Elimination Half Life (T 1/2)

T 1/2 = terminal elimination half life of atazanavir at specified time points.

Treated participants in the PK concentration data set.

Posted

Geometric Mean

95% Confidence Interval

Hours

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

ID	Title	Description
OG000	Mothers ATV 300 mg / 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG00010.42(9.14 to 11.89) OG00112.10(9.44 to 15.51) OG00212.17(10.42 to 14.21)

Secondary

Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration

Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery.

Posted

Mean

Standard Deviation

ng / mL

At Time of Delivery

ID	Title	Description
OG000	Mothers ATV 300 mg / RTV 100 mg	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 400 mg / RTV 100 mg	Infants born to mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00121

Title

Denominators

Categories

Maternal Serum Concentration

Title	Measurements
	OG0001,412.05± 888.85 OG0011,568.06± 846.44

Cord Blood Concentration

Title	Measurements
	OG000

Secondary

Median Infant Total Bilirubin Level

Median infant total bilirubin level as measured at specified time points.

Posted

Median

Inter-Quartile Range

mg / dL

Birth (Day 1), Day 3, Day 5, and Day 7 of Life

ID	Title	Description
OG000	Infant ATV 300 mg / RTV 100 mg	Infants of mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Infant ATV 400 mg / RTV 100 mg	Infansts of mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Day 1 (Birth)

Title	Measurements
	OG0003.20(2.80 to 4.30) OG0013.25(2.80 to 4.40)

Day 3

Title	Measurements
	OG000

Secondary

Mean Atazanavir Plasma Protein Binding

Atazanavir Plasma Protein Binding Percentage measured at specified time points.

Posted

Mean

Standard Deviation

Percentage Bound

Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery

ID	Title	Description
OG000	Mother ATV 300 mg / RTV 100 mg	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mother ATV 400 mg / RTV 100 mg	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00121

Title

Denominators

Categories

Third Trimester 3 Hours Post Dose (n = 20, 20)

Title	Measurements
	OG00091.34± 2.32 OG00187.70± 2.69

Third Trimester 24 Hours Post Dose (n = 19, 20)

Title	Measurements
	OG000

Secondary

Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose

The MACS was administered to evaluate participant adherence to each drug and the adherence to the regimen. The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.

All treated participants were included in this evaluation.

Posted

Number

Participants

Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum

ID	Title	Description
OG000	Mother ATV 300 mg / RTV 100 mg	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mother ATV 400 mg / RTV 100 mg	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG00020 OG00121

Title

Denominators

Categories

Study Week 2 Regimen (n = 20,18)

Title	Measurements
	OG00020 OG00117

Study Week 2 ATV (n = 20,18)

Title	Measurements
	OG000

Primary

Mean RTV Terminal Elimination Half Life (T 1/2)

T 1/2 = terminal elimination half life of ritonavir at specified time points.

Treated participants in the PK concentration data set

Posted

Geometric Mean

95% Confidence Interval

Hours

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

ID	Title	Description
OG000	Mothers ATV 300 mg / 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG0005.03(4.51 to 5.60) OG0015.28(4.73 to 5.90) OG0025.10(4.30 to 6.05)

Primary

Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)

Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.

Treated participants in the PK concentration data set.

Posted

Geometric Mean

95% Confidence Interval

Hours

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum

ID	Title	Description
OG000	Mothers ATV 300 mg / 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG0003.68(2.92 to 4.64) OG0012.94(2.36 to 3.65) OG0023.30(2.57 to 4.23)

Primary

Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)

Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.

Treated participants in the PK concentration data set.

Posted

Geometric Mean

95% Confidence Interval

Hours

Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum

ID	Title	Description
OG000	Mothers ATV 300 mg / 100 mg Second Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG001	Mothers ATV 300 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
OG002	Mothers ATV 400 mg / 100 mg Third Trimester	Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Units	Counts
Participants	OG0009 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG0006.11(3.81 to 9.80) OG0014.15(3.12 to 5.54) OG0024.63(3.45 to 6.19)

Prematurity Causing Discontinuation (n=41, n=40)

Title	Measurements
	OG000NAPrematurity causing discontinuation was considered an infant only AE/SAE and thus was not deemed appropriate for evaluation in the mothers only population. OG0011

Visit 4 Pregnancy Wk 20 to 28 Regimen (n=0, 13)

Title	Measurements
	OG000NAParticipants were titrated to the ATV 400 mg / RTV 100 mg prior to this visit and thus data are not available for this dosing group. OG00113

Visit 4 Pregnancy Week 20 to 28 ATV (n=0, 13)

Title	Measurements
	OG000NAParticipants were titrated to the ATV 400 mg / RTV 100 mg prior to this visit and thus data are not available for this dosing group. OG00113

Visit 4 Pregnancy Week 20 to 28 RTV (n=0, 13)

Title	Measurements
	OG000NAParticipants were titrated to the ATV 400 mg / RTV 100 mg prior to this visit and thus data are not available for this dosing group. OG00113

Visit 4 Pregnancy Wk 20 to 28 ZDV/3TC (n=0, 13)

Title	Measurements
	OG000NAParticipants were titrated to the ATV 400 mg / RTV 100 mg prior to this visit and thus data are not available for this dosing group. OG00113

Visit 6 Pregnancy Wk 28 to Birth Regimen (n=0, 1)

Title	Measurements
	OG000NAParticipants experienced a dose escalation from ATV 300 mg / RTV 100 mg to ATV 400 mg / RTV 100 mg in the third trimester and thus this value was not calculated. OG0011

Visit 6 Pregnancy Week 28 to Birth ATV (n=0, 1)

Title	Measurements
	OG000NAParticipants experienced a dose escalation from ATV 300 mg / RTV 100 mg to ATV 400 mg / RTV 100 mg in the third trimester and thus this value was not calculated. OG0011

Visit 6 Pregnancy Week 28 to Birth RTV (n=0, 1)

Title	Measurements
	OG000NAParticipants experienced a dose escalation from ATV 300 mg / RTV 100 mg to ATV 400 mg / RTV 100 mg in the third trimester and thus this value was not calculated. OG0011

Visit 6 Pregnancy Wk 28 to Birth ZDV/3TC (n=0, 1)

Title	Measurements
	OG000NAParticipants experienced a dose escalation from ATV 300 mg / RTV 100 mg to ATV 400 mg / RTV 100 mg in the third trimester and thus this value was not calculated. OG0011