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Trial Outcomes & Findings for Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women (NCT NCT00326716)

NCT ID: NCT00326716

Last Updated: 2011-11-16

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

69 participants

Primary outcome timeframe

At the time of delivery

Results posted on

2011-11-16

Participant Flow

Pregnant participants were enrolled at 6 sites: United States (2), South Africa (3), and Puerto Rico (1).

Of the 69 enrolled participants, 28 mothers were not treated. Failure to continue to meet enrollment criteria resulting in discontinuation in 24/28 participants and 4 were not treated: 1 poor/no compliance, 1 met exclusion criteria, 1 was ARV naive subject with HIV RNA \< 400 c/mL, and 1 was unable to comply with study procedures.

Participant milestones

Participant milestones
Measure
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.
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.
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.
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.
Pre-Natal Mothers
STARTED
20
21
0
0
Pre-Natal Mothers
COMPLETED
19
19
0
0
Pre-Natal Mothers
NOT COMPLETED
1
2
0
0
Infants
STARTED
0
0
20
20
Infants
COMPLETED
0
0
20
20
Infants
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
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.
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.
Pre-Natal Mothers
Discontinued ATV Before Delivery
1
2
0
0

Baseline Characteristics

Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mother ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mother ATV 400 mg / RTV 100 mg
n=21 Participants
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.
Total
n=41 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
21 Participants
n=7 Participants
41 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
29 Years
n=5 Participants
28 Years
n=7 Participants
28 Years
n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
21 Participants
n=7 Participants
41 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
17 Participants
n=5 Participants
19 Participants
n=7 Participants
36 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
North America
6 participants
n=5 Participants
6 participants
n=7 Participants
12 participants
n=5 Participants
Region of Enrollment
Africa
14 participants
n=5 Participants
15 participants
n=7 Participants
29 participants
n=5 Participants
HIV RNA Distribution at Baseline
<50
3 c/mL
n=5 Participants
1 c/mL
n=7 Participants
4 c/mL
n=5 Participants
HIV RNA Distribution at Baseline
50 to < 30,000
13 c/mL
n=5 Participants
13 c/mL
n=7 Participants
26 c/mL
n=5 Participants
HIV RNA Distribution at Baseline
30,000 to < 100,000
3 c/mL
n=5 Participants
6 c/mL
n=7 Participants
9 c/mL
n=5 Participants
HIV RNA Distribution at Baseline
>= 100,000
1 c/mL
n=5 Participants
1 c/mL
n=7 Participants
2 c/mL
n=5 Participants
Infant Gestational Age at Delivery
38 Weeks
n=5 Participants
38 Weeks
n=7 Participants
38 Weeks
n=5 Participants

PRIMARY outcome

Timeframe: At the time of delivery

Population: All infants.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
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.
Infant Gestational Age at Delivery
38 Weeks
Standard Error 0.3
38 Weeks
Standard Error 0.3
—

PRIMARY outcome

Timeframe: At the time of delivery

Population: All infants.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
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.
Infant Gender
Male
12 Participants
9 Participants
—
Infant Gender
Female
8 Participants
11 Participants
—

PRIMARY outcome

Timeframe: At the time of delivery

Population: All infants.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
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.
Infant Race
Black
15 Participants
18 Participants
—
Infant Race
White
5 Participants
1 Participants
—
Infant Race
Mixed Race
0 Participants
1 Participants
—

PRIMARY outcome

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

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

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval
3,729.09 ng / mL
3,291.46 ng / mL
4,210.76 ng / mL

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval
530.81 ng / mL
Interval 333.2 to 845.61
587.36 ng / mL
Interval 423.55 to 814.52
524.48 ng / mL
Interval 368.76 to 745.95

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean ATV Area Under the Concentration Curve (AUC TAU)
34,399.13 ng•h / mL
34,251.50 ng•h / mL
46,602.45 ng•h / mL

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean RTV Area Under the Concentration Curve (AUC TAU)
4,500.03 ng•h / mL
4,664.93 ng•h / mL
4,383.30 ng•h / mL

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
663.78 ng•h / mL
Interval 492.65 to 894.35
668.48 ng•h / mL
Interval 529.06 to 844.64
916.63 ng•h / mL
Interval 665.77 to

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
50.10 ng•h / mL
Interval 28.39 to 88.43
41.12 ng•h / mL
Interval 29.06 to 58.21
38.05 ng•h / mL
Interval 26.24 to 55.17

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean ATV Terminal Elimination Half Life (T 1/2)
10.42 Hours
Interval 9.14 to 11.89
12.10 Hours
Interval 9.44 to 15.51
12.17 Hours
Interval 10.42 to 14.21

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean RTV Terminal Elimination Half Life (T 1/2)
5.03 Hours
Interval 4.51 to 5.6
5.28 Hours
Interval 4.73 to 5.9
5.10 Hours
Interval 4.3 to 6.05

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)
3.68 Hours
Interval 2.92 to 4.64
2.94 Hours
Interval 2.36 to 3.65
3.30 Hours
Interval 2.57 to 4.23

PRIMARY outcome

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

Population: Treated participants in the PK concentration data set.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=9 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg Third Trimester
n=20 Participants
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.
Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)
6.11 Hours
Interval 3.81 to 9.8
4.15 Hours
Interval 3.12 to 5.54
4.63 Hours
Interval 3.45 to 6.19

SECONDARY outcome

Timeframe: Day of Delivery ± 2 Days

Population: 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.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=19 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
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.
Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery
HIV RNA < 400 copies/mL
19 Participants
20 Participants
—
Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery
HIV RNA < 50 copies/mL
19 Participants
19 Participants
—

SECONDARY outcome

Timeframe: Baseline, Day of Delivery ± 2 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=18 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=19 Participants
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.
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.
Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level
-1.8 log10 c / mL
Interval -2.43 to -1.39
-2.37 log10 c / mL
Interval -2.93 to -1.81
—

SECONDARY outcome

Timeframe: Baseline

Population: All treated participants.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=21 Participants
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.
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.
Mean HIV RNA Level at Baseline
3.520 log10 cm / mL
Standard Error 0.232
4.020 log10 cm / mL
Standard Error 0.171
—

SECONDARY outcome

Timeframe: Baseline, Day of Delivery ± 2 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=17 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
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.
Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count
89 cells / mm^3
Interval -75.0 to 213.0
174 cells / mm^3
Interval -39.0 to 257.0
—

SECONDARY outcome

Timeframe: Baseline

Population: All treated participants.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=21 Participants
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.
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.
Mean CD4 Cell Count at Baseline
435.0 cells / mm^3
Standard Error 39.2
390.0 cells / mm^3
Standard Error 25.0
—

SECONDARY outcome

Timeframe: Birth Through 6 Months on Study

Population: All infants.

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
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.
Infant HIV Status
HIV Positive
0 Participants
0 Participants
—
Infant HIV Status
HIV Negative
20 Participants
20 Participants
—

SECONDARY outcome

Timeframe: During study period and 30 days post-study.

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=41 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=40 Participants
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.
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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Death (n=41, n=40)
0 Participants
0 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Event (n=41, n=40)
16 Participants
14 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Total AEs Leading to Discontinuation (n=41, n=40)
2 Participants
2 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Anemia Leading to Discontinuation (n=41, n=40)
1 Participants
2 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Transaminitis Discontinuation (n=41, n=40)
1 Participants
0 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prematurity Causing Discontinuation (n=41, n=40)
NA Participants
Prematurity causing discontinuation was considered an infant only AE/SAE and thus was not deemed appropriate for evaluation in the mothers only population.
1 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
All AEs (n=41, n=40)
40 Participants
40 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Anemia (n=41, n=40)
6 Participants
3 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Diarrhea (n=41, n=40)
4 Participants
4 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Nausea (n=41, n=40)
6 Participants
0 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Vomiting (n=41, n=40)
7 Participants
5 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Jaundice (n=41, n=40)
10 Participants
20 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hyperbilirubinemia (n=41, n=40)
1 Participants
1 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Ocular Icterus (n=41, n=40)
3 Participants
0 Participants
—
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Skin / subcutaneous tissue disorders (n=41, n=40)
10 Participants
20 Participants
—

SECONDARY outcome

Timeframe: During Study Period and 30 Days Post-Study.

Population: 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.

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 \[potentially life threatening\]).

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=41 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=40 Participants
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.
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.
Number of Participants With Grade 2 to Grade 4 AEs and SAEs
Grade 2 to Grade 4 (n=41, n=40)
32 Participants
19 Participants
—
Number of Participants With Grade 2 to Grade 4 AEs and SAEs
Related Grade 2 to Grade 4 (n=41, n=40)
10 Participants
0 Participants
—
Number of Participants With Grade 2 to Grade 4 AEs and SAEs
Grade 3 to Grade 4 (n=41, n=40)
12 Participants
8 Participants
—
Number of Participants With Grade 2 to Grade 4 AEs and SAEs
Grade 3 to Grade 4 Total Bilirubin (n=41, n=40)
19 Participants
7 Participants
—

SECONDARY outcome

Timeframe: During Study Period and 30 Days Post-Study.

Population: Data were analyzed for all treated and untreated 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.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=21 Participants
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.
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.
SAEs in Enrolled Mothers
Any Adverse Experience
7 Participants
8 Participants
—
SAEs in Enrolled Mothers
Blood and Lymphatic System Disorders
1 Participants
2 Participants
—
SAEs in Enrolled Mothers
Anemia
1 Participants
2 Participants
—
SAEs in Enrolled Mothers
Cardiac Disorders
1 Participants
1 Participants
—
SAEs in Enrolled Mothers
Cardiomyopathy
1 Participants
0 Participants
—
SAEs in Enrolled Mothers
Sinus Arrhythmia
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Gastrointestinal Disorders
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Abdominal Hernia
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Hepatobiliary Disorders
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Hyperbilirubinemia
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Infections and Infestations
2 Participants
2 Participants
—
SAEs in Enrolled Mothers
Endometrial Decidual
2 Participants
0 Participants
—
SAEs in Enrolled Mothers
Pneumonia
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Sepsis
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Investigations
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Transaminases Increased
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Pregnancy, Puerperium, and Perinatal Conditions
2 Participants
2 Participants
—
SAEs in Enrolled Mothers
Amenorrhea
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Pre-eclampsia
1 Participants
1 Participants
—
SAEs in Enrolled Mothers
Pregnancy Induced Hypertension
0 Participants
0 Participants
—
SAEs in Enrolled Mothers
Premature Rupture of Membranes
1 Participants
0 Participants
—
SAEs in Enrolled Mothers
Vascular Disorders
1 Participants
1 Participants
—
SAEs in Enrolled Mothers
Hypertension
0 Participants
1 Participants
—
SAEs in Enrolled Mothers
Hemorrhage
1 Participants
0 Participants
—

SECONDARY outcome

Timeframe: Birth Through Week 16 of Life

Population: SAEs were recorded for all enrolled infants.

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.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
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.
SAEs in Enrolled Infants
Pneumonia
0 Participants
1 Participants
—
SAEs in Enrolled Infants
Any Adverse Experience
10 Participants
4 Participants
—
SAEs in Enrolled Infants
Blood and Lymphatic System Disorders
1 Participants
1 Participants
—
SAEs in Enrolled Infants
Anemia
1 Participants
1 Participants
—
SAEs in Enrolled Infants
Cardiac Disorders
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Cardio-Respiratory Arrest
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Restrictive Cardiomyopathy
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Congenital, Familial, and Genetic Disorders
0 Participants
1 Participants
—
SAEs in Enrolled Infants
Atrial Septal Defect
0 Participants
1 Participants
—
SAEs in Enrolled Infants
Gastrointestinal Disorders
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Constipation
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Vomiting
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Hepatobiliary Disorders
1 Participants
1 Participants
—
SAEs in Enrolled Infants
Hyperbilirubinemia
0 Participants
1 Participants
—
SAEs in Enrolled Infants
Jaundice
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Infections and Infestations
4 Participants
2 Participants
—
SAEs in Enrolled Infants
Bronchiolitis
0 Participants
2 Participants
—
SAEs in Enrolled Infants
Gastroenteritis
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Meningitis
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Sepsis
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Syphilis
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Injury, Poisoning, and Procedural Complications
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Overdose
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Metabolism and Nutrition Disorders
1 Participants
1 Participants
—
SAEs in Enrolled Infants
Hyperkalemia
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Hypoglycemia
0 Participants
1 Participants
—
SAEs in Enrolled Infants
Nervous System Disorders
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Cerebral Ischemia
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Convulsion
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Pregnancy, Puerperium, and Perinatal Conditions
1 Participants
1 Participants
—
SAEs in Enrolled Infants
Premature Baby
1 Participants
1 Participants
—
SAEs in Enrolled Infants
Respiratory, Thoracic, and Mediastinal Disorders
2 Participants
0 Participants
—
SAEs in Enrolled Infants
Neonatal Respiratory Distress Syndrome
1 Participants
0 Participants
—
SAEs in Enrolled Infants
Respiratory Distress
1 Participants
0 Participants
—

SECONDARY outcome

Timeframe: At Time of Delivery

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=21 Participants
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.
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.
Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration
Maternal Serum Concentration
1,412.05 ng / mL
Standard Deviation 888.85
1,568.06 ng / mL
Standard Deviation 846.44
—
Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration
Cord Blood Concentration
273.20 ng / mL
Standard Deviation 182.04
231.49 ng / mL
Standard Deviation 158.29
—

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=20 Participants
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.
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.
Median Infant Total Bilirubin Level
Day 1 (Birth)
3.20 mg / dL
Interval 2.8 to 4.3
3.25 mg / dL
Interval 2.8 to 4.4
—
Median Infant Total Bilirubin Level
Day 3
8.40 mg / dL
Interval 5.4 to 11.3
9.20 mg / dL
Interval 7.0 to 9.6
—
Median Infant Total Bilirubin Level
Day 5
7.10 mg / dL
Interval 3.05 to 10.2
9.25 mg / dL
Interval 5.5 to 10.45
—
Median Infant Total Bilirubin Level
Day 7
5.10 mg / dL
Interval 1.9 to 8.9
7.30 mg / dL
Interval 2.5 to 9.3
—

SECONDARY outcome

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

Atazanavir Plasma Protein Binding Percentage measured at specified time points.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=21 Participants
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.
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.
Mean Atazanavir Plasma Protein Binding
Third Trimester 3 Hours Post Dose (n = 20, 20)
91.34 Percentage Bound
Standard Deviation 2.32
87.70 Percentage Bound
Standard Deviation 2.69
—
Mean Atazanavir Plasma Protein Binding
Third Trimester 24 Hours Post Dose (n = 19, 20)
90.37 Percentage Bound
Standard Deviation 2.58
88.89 Percentage Bound
Standard Deviation 2.40
—
Mean Atazanavir Plasma Protein Binding
Time of Delivery (n = 15, 12)
77.05 Percentage Bound
Standard Deviation 6.88
75.62 Percentage Bound
Standard Deviation 4.34
—

SECONDARY outcome

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

Population: All treated participants were included in this evaluation.

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.

Outcome measures

Outcome measures
Measure
Mothers ATV 300 mg / RTV 100 mg
n=20 Participants
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.
Mothers ATV 400 mg / RTV 100 mg
n=21 Participants
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.
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.
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Study Week 2 Regimen (n = 20,18)
20 Participants
17 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Study Week 2 ATV (n = 20,18)
20 Participants
17 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Study Week 2 RTV (n = 20,18)
20 Participants
17 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Study Week 2 ZDV/3TC (n = 20,18)
20 Participants
17 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 1 Pregnancy Week 20 to 28 Regimen (n=12, 9)
11 Participants
8 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 1 Pregnancy Week 20 to 28 ATV (n=12, 9)
12 Participants
8 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 1 Pregnancy Week 20 to 28 RTV (n=12, 9)
12 Participants
9 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 1 Pregnancy Week 20 to 28 ZDV/3TC (n=12, 9)
11 Participants
9 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 2 Pregnancy Week 20 to 28 Regimen (n=8, 5)
3 Participants
3 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 2 Pregnancy Week 20 to 28 ATV (n=8, 5)
8 Participants
5 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 2 Pregnancy Week 20 to 28 RTV (n=8, 5)
7 Participants
4 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 2 Pregnancy Week 20 to 28 ZDV/3TC (n=8, 5)
4 Participants
4 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 3 Pregnancy Week 20 to 28 Regimen (n=6, 2)
4 Participants
2 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 3 Pregnancy Week 20 to 28 ATV (n=6, 2)
5 Participants
2 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 3 Pregnancy Week 20 to 28 RTV (n=6, 2)
5 Participants
2 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 3 Pregnancy Week 20 to 28 ADV/3TC (n=6, 2)
4 Participants
2 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 4 Pregnancy Wk 20 to 28 Regimen (n=0, 13)
NA Participants
Participants were titrated to the ATV 400 mg / RTV 100 mg prior to this visit and thus data are not available for this dosing group.
13 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 4 Pregnancy Week 20 to 28 ATV (n=0, 13)
NA Participants
Participants were titrated to the ATV 400 mg / RTV 100 mg prior to this visit and thus data are not available for this dosing group.
13 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 4 Pregnancy Week 20 to 28 RTV (n=0, 13)
NA Participants
Participants were titrated to the ATV 400 mg / RTV 100 mg prior to this visit and thus data are not available for this dosing group.
13 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 4 Pregnancy Wk 20 to 28 ZDV/3TC (n=0, 13)
NA Participants
Participants were titrated to the ATV 400 mg / RTV 100 mg prior to this visit and thus data are not available for this dosing group.
13 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 1 Pregnancy Wk 20 to Birth Regimen (n=20,20)
19 Participants
20 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 1 Pregnancy Week 20 to Birth ATV (n=20,20)
20 Participants
20 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 1 Pregnancy Week 20 to Birth RTV (n=20,20)
20 Participants
20 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 1 Pregnancy Wk 20 to Birth ZDV/3TC (n=20,20)
19 Participants
20 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 2 Pregnancy Wk 20 to Birth Regimen (n=19,19)
18 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 2 Pregnancy Week 20 to Birth ATV (n=19,19)
19 Participants
19 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 2 Pregnancy Week 20 to Birth RTV (n=19,19)
19 Participants
19 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 2 Pregnancy Wk 20 to Birth ZDV/3TC (n=19,19)
18 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 3 Pregnancy Wk 20 to Birth Regimen (n=15,19)
12 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 3 Pregnancy Week 20 to Birth ATV (n=15,19)
13 Participants
19 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 3 Pregnancy Week 20 to Birth RTV (n=15,19)
13 Participants
19 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 3 Pregnancy Wk 20 to Birth ZDV/3TC (n=15,19)
12 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 4 Pregnancy Wk 28 to Birth Regimen (n=5,15)
5 Participants
15 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 4 Pregnancy Week 28 to Birth ATV (n=5,15)
5 Participants
15 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 4 Pregnancy Week 28 to Birth RTV (n=5,15)
5 Participants
15 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 4 Pregnancy Wk 28 to Birth ZDV/3TC (n=5,15)
5 Participants
15 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 5 Pregnancy Wk 28 to Birth Regimen (n=1, 2)
1 Participants
2 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 5 Pregnancy Week 28 to Birth ATV (n=1, 2)
1 Participants
2 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 5 Pregnancy Week 28 to Birth RTV (n=1, 2)
1 Participants
2 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 5 Pregnancy Wk 28 to Birth ZDV/3TC (n=1, 2)
1 Participants
2 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 6 Pregnancy Wk 28 to Birth Regimen (n=0, 1)
NA Participants
Participants 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.
1 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 6 Pregnancy Week 28 to Birth ATV (n=0, 1)
NA Participants
Participants 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.
1 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 6 Pregnancy Week 28 to Birth RTV (n=0, 1)
NA Participants
Participants 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.
1 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Visit 6 Pregnancy Wk 28 to Birth ZDV/3TC (n=0, 1)
NA Participants
Participants 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.
1 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Postpartum Week 2 Regimen (n=19, 19)
14 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Postpartum Week 2 ATV (n=18, 19)
16 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Postpartum Week 2 RTV (n=18, 19)
16 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Postpartum Week 2 ZDV/3TC (n =19, 19)
14 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Postpartum Week 4 Regimen (n=17, 19)
16 Participants
18 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Postpartum Week 4 ATV (n=17, 19)
17 Participants
19 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Postpartum Week 4 RTV (n=17, 19)
16 Participants
19 Participants
—
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Postpartum Week 4 ZDV/3TC (n=17, 19)
17 Participants
18 Participants
—

Adverse Events

Infant ATV 300 mg / RTV 100 mg

Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths

Infant ATV 400 mg / RTV 100 mg

Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths

Mother ATV 300 mg / RTV 100 mg

Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths

Mother ATV 400 mg / RTV 100 mg

Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Infant ATV 300 mg / RTV 100 mg
n=20 participants at risk
Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
Infant ATV 400 mg / RTV 100 mg
n=20 participants at risk
Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
Mother ATV 300 mg / RTV 100 mg
n=20 participants at risk
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.
Mother ATV 400 mg / RTV 100 mg
n=21 participants at risk
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.
Investigations
TRANSAMINASES INCREASED
0.00%
0/20
0.00%
0/20
0.00%
0/20
4.8%
1/21
Cardiac disorders
CARDIOMYOPATHY
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Cardiac disorders
SINUS ARRHYTHMIA
0.00%
0/20
0.00%
0/20
0.00%
0/20
4.8%
1/21
Cardiac disorders
CARDIO-RESPIRATORY ARREST
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Cardiac disorders
RESTRICTIVE CARDIOMYOPATHY
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Vascular disorders
HAEMORRHAGE
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Vascular disorders
HYPERTENSION
0.00%
0/20
0.00%
0/20
0.00%
0/20
4.8%
1/21
Hepatobiliary disorders
JAUNDICE
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
0.00%
0/20
5.0%
1/20
0.00%
0/20
4.8%
1/21
Nervous system disorders
CONVULSION
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Nervous system disorders
CEREBRAL ISCHAEMIA
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Gastrointestinal disorders
VOMITING
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Gastrointestinal disorders
CONSTIPATION
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Gastrointestinal disorders
ABDOMINAL HERNIA
0.00%
0/20
0.00%
0/20
0.00%
0/20
4.8%
1/21
Infections and infestations
SEPSIS
5.0%
1/20
0.00%
0/20
0.00%
0/20
4.8%
1/21
Infections and infestations
SYPHILIS
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
PNEUMONIA
0.00%
0/20
5.0%
1/20
0.00%
0/20
4.8%
1/21
Infections and infestations
MENINGITIS
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
BRONCHIOLITIS
0.00%
0/20
10.0%
2/20
0.00%
0/20
0.00%
0/21
Infections and infestations
GASTROENTERITIS
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
ENDOMETRITIS DECIDUAL
0.00%
0/20
0.00%
0/20
10.0%
2/20
0.00%
0/21
Metabolism and nutrition disorders
HYPERKALAEMIA
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Metabolism and nutrition disorders
HYPOGLYCAEMIA
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Blood and lymphatic system disorders
ANAEMIA
5.0%
1/20
5.0%
1/20
5.0%
1/20
9.5%
2/21
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Injury, poisoning and procedural complications
OVERDOSE
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Pregnancy, puerperium and perinatal conditions
AMNIORRHOEA
0.00%
0/20
0.00%
0/20
0.00%
0/20
4.8%
1/21
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
Pregnancy, puerperium and perinatal conditions
PREMATURE BABY
5.0%
1/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Pregnancy, puerperium and perinatal conditions
PREMATURE RUPTURE OF MEMBRANES
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
NEONATAL RESPIRATORY DISTRESS SYNDROME
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21

Other adverse events

Other adverse events
Measure
Infant ATV 300 mg / RTV 100 mg
n=20 participants at risk
Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
Infant ATV 400 mg / RTV 100 mg
n=20 participants at risk
Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
Mother ATV 300 mg / RTV 100 mg
n=20 participants at risk
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.
Mother ATV 400 mg / RTV 100 mg
n=21 participants at risk
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.
Eye disorders
CONJUNCTIVITIS
15.0%
3/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Eye disorders
OCULAR ICTERUS
0.00%
0/20
0.00%
0/20
10.0%
2/20
4.8%
1/21
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Investigations
CARDIAC MURMUR
0.00%
0/20
10.0%
2/20
0.00%
0/20
0.00%
0/21
Investigations
WEIGHT DECREASED
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Investigations
HAEMOGLOBIN DECREASED
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Investigations
CULTURE URINE POSITIVE
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Investigations
WHITE BLOOD CELLS URINE POSITIVE
0.00%
0/20
0.00%
0/20
10.0%
2/20
0.00%
0/21
Investigations
ELECTROCARDIOGRAM T WAVE INVERSION
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Vascular disorders
HYPERTENSION
0.00%
0/20
0.00%
0/20
15.0%
3/20
14.3%
3/21
Psychiatric disorders
DEPRESSION
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Hepatobiliary disorders
JAUNDICE
45.0%
9/20
50.0%
10/20
20.0%
4/20
28.6%
6/21
Hepatobiliary disorders
HEPATOMEGALY
0.00%
0/20
10.0%
2/20
0.00%
0/20
0.00%
0/21
Nervous system disorders
SYNCOPE
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Nervous system disorders
HEADACHE
0.00%
0/20
0.00%
0/20
35.0%
7/20
9.5%
2/21
Nervous system disorders
SCIATICA
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Nervous system disorders
DIZZINESS
0.00%
0/20
0.00%
0/20
15.0%
3/20
4.8%
1/21
Nervous system disorders
POST HERPETIC NEURALGIA
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Gastrointestinal disorders
NAUSEA
0.00%
0/20
0.00%
0/20
20.0%
4/20
9.5%
2/21
Gastrointestinal disorders
VOMITING
5.0%
1/20
15.0%
3/20
25.0%
5/20
9.5%
2/21
Gastrointestinal disorders
DIARRHOEA
5.0%
1/20
15.0%
3/20
15.0%
3/20
4.8%
1/21
Gastrointestinal disorders
DYSPEPSIA
0.00%
0/20
0.00%
0/20
15.0%
3/20
9.5%
2/21
Gastrointestinal disorders
TOOTHACHE
0.00%
0/20
0.00%
0/20
15.0%
3/20
4.8%
1/21
Gastrointestinal disorders
CONSTIPATION
5.0%
1/20
15.0%
3/20
10.0%
2/20
4.8%
1/21
Gastrointestinal disorders
ABDOMINAL PAIN
5.0%
1/20
10.0%
2/20
10.0%
2/20
4.8%
1/21
Gastrointestinal disorders
ABDOMINAL HERNIA
0.00%
0/20
5.0%
1/20
0.00%
0/20
4.8%
1/21
Gastrointestinal disorders
MOUTH ULCERATION
5.0%
1/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Gastrointestinal disorders
UMBILICAL HERNIA
10.0%
2/20
15.0%
3/20
0.00%
0/20
0.00%
0/21
Gastrointestinal disorders
TONGUE GEOGRAPHIC
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Gastrointestinal disorders
RECTAL HAEMORRHAGE
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Gastrointestinal disorders
ABDOMINAL DISTENSION
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
0.00%
0/20
0.00%
0/20
10.0%
2/20
0.00%
0/21
Gastrointestinal disorders
PAROTID GLAND ENLARGEMENT
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
5.0%
1/20
20.0%
4/20
5.0%
1/20
0.00%
0/21
Infections and infestations
IMPETIGO
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
MASTITIS
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
RHINITIS
0.00%
0/20
15.0%
3/20
0.00%
0/20
9.5%
2/21
Infections and infestations
INFLUENZA
0.00%
0/20
5.0%
1/20
5.0%
1/20
9.5%
2/21
Infections and infestations
SINUSITIS
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
BODY TINEA
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Infections and infestations
BRONCHITIS
10.0%
2/20
0.00%
0/20
0.00%
0/20
14.3%
3/21
Infections and infestations
TRACHEITIS
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
CANDIDIASIS
5.0%
1/20
10.0%
2/20
0.00%
0/20
0.00%
0/21
Infections and infestations
ORAL HERPES
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
PHARYNGITIS
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
TONSILLITIS
0.00%
0/20
0.00%
0/20
0.00%
0/20
9.5%
2/21
Infections and infestations
ENDOMETRITIS
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
OTITIS MEDIA
15.0%
3/20
5.0%
1/20
0.00%
0/20
4.8%
1/21
Infections and infestations
SKIN CANDIDA
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Infections and infestations
WOUND SEPSIS
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
BRONCHIOLITIS
10.0%
2/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
HERPES ZOSTER
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
GASTROENTERITIS
5.0%
1/20
5.0%
1/20
0.00%
0/20
4.8%
1/21
Infections and infestations
NASOPHARYNGITIS
0.00%
0/20
5.0%
1/20
10.0%
2/20
4.8%
1/21
Infections and infestations
VIRAL INFECTION
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
WOUND INFECTION
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
ORAL CANDIDIASIS
15.0%
3/20
15.0%
3/20
10.0%
2/20
0.00%
0/21
Infections and infestations
VAGINAL INFECTION
0.00%
0/20
0.00%
0/20
0.00%
0/20
9.5%
2/21
Infections and infestations
VAGINITIS BACTERIAL
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
Infections and infestations
FUNGAL SKIN INFECTION
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Infections and infestations
URINARY TRACT INFECTION
0.00%
0/20
0.00%
0/20
5.0%
1/20
28.6%
6/21
Infections and infestations
SKIN BACTERIAL INFECTION
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
VULVOVAGINAL CANDIDIASIS
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
20.0%
4/20
50.0%
10/20
40.0%
8/20
19.0%
4/21
Renal and urinary disorders
DYSURIA
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Renal and urinary disorders
PROTEINURIA
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Metabolism and nutrition disorders
ANOREXIA
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
Metabolism and nutrition disorders
HYPOGLYCAEMIA
5.0%
1/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Metabolism and nutrition disorders
DECREASED APPETITE
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Metabolism and nutrition disorders
GESTATIONAL DIABETES
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Blood and lymphatic system disorders
ANAEMIA
5.0%
1/20
5.0%
1/20
10.0%
2/20
19.0%
4/21
Blood and lymphatic system disorders
LYMPHADENOPATHY
5.0%
1/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
RASH
15.0%
3/20
20.0%
4/20
5.0%
1/20
14.3%
3/21
Skin and subcutaneous tissue disorders
ECZEMA
10.0%
2/20
15.0%
3/20
5.0%
1/20
4.8%
1/21
Skin and subcutaneous tissue disorders
DRY SKIN
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
PRURITUS
0.00%
0/20
0.00%
0/20
0.00%
0/20
14.3%
3/21
Skin and subcutaneous tissue disorders
HEAT RASH
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
PETECHIAE
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
DERMATITIS
10.0%
2/20
10.0%
2/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
SEBORRHOEA
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
RASH MACULAR
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
RASH GENERALISED
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Skin and subcutaneous tissue disorders
NAIL PIGMENTATION
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Skin and subcutaneous tissue disorders
NAIL DISCOLOURATION
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
5.0%
1/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Reproductive system and breast disorders
PELVIC PAIN
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
Reproductive system and breast disorders
VAGINAL DISCHARGE
0.00%
0/20
0.00%
0/20
10.0%
2/20
9.5%
2/21
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
0.00%
0/20
0.00%
0/20
0.00%
0/20
9.5%
2/21
Congenital, familial and genetic disorders
HYDROCELE
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Congenital, familial and genetic disorders
CONGENITAL NAEVUS
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Injury, poisoning and procedural complications
OVERDOSE
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Injury, poisoning and procedural complications
ARTHROPOD BITE
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Injury, poisoning and procedural complications
PROCEDURAL PAIN
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Injury, poisoning and procedural complications
SKIN LACERATION
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Injury, poisoning and procedural complications
VACCINATION COMPLICATION
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Pregnancy, puerperium and perinatal conditions
PREMATURE LABOUR
0.00%
0/20
0.00%
0/20
15.0%
3/20
4.8%
1/21
Pregnancy, puerperium and perinatal conditions
PROLONGED LABOUR
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Pregnancy, puerperium and perinatal conditions
CAPUT SUCCEDANEUM
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Pregnancy, puerperium and perinatal conditions
JAUNDICE NEONATAL
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Pregnancy, puerperium and perinatal conditions
NEONATAL DISORDER
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Pregnancy, puerperium and perinatal conditions
FOETAL DISTRESS SYNDROME
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Pregnancy, puerperium and perinatal conditions
PREGNANCY INDUCED HYPERTENSION
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
Pregnancy, puerperium and perinatal conditions
PREMATURE RUPTURE OF MEMBRANES
0.00%
0/20
0.00%
0/20
20.0%
4/20
4.8%
1/21
Musculoskeletal and connective tissue disorders
BURSITIS
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Musculoskeletal and connective tissue disorders
BACK PAIN
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
Musculoskeletal and connective tissue disorders
ARTHRALGIA
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Musculoskeletal and connective tissue disorders
JOINT HYPEREXTENSION
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
COUGH
25.0%
5/20
0.00%
0/20
20.0%
4/20
14.3%
3/21
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
SNEEZING
5.0%
1/20
0.00%
0/20
0.00%
0/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
0.00%
0/20
15.0%
3/20
0.00%
0/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
5.0%
1/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
35.0%
7/20
5.0%
1/20
0.00%
0/20
4.8%
1/21
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
NOCTURNAL DYSPNOEA
0.00%
0/20
0.00%
0/20
5.0%
1/20
0.00%
0/21
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
General disorders
MASS
0.00%
0/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
General disorders
PAIN
0.00%
0/20
0.00%
0/20
5.0%
1/20
4.8%
1/21
General disorders
FATIGUE
0.00%
0/20
0.00%
0/20
20.0%
4/20
0.00%
0/21
General disorders
PYREXIA
5.0%
1/20
5.0%
1/20
0.00%
0/20
0.00%
0/21
General disorders
OEDEMA PERIPHERAL
0.00%
0/20
0.00%
0/20
5.0%
1/20
9.5%
2/21

Additional Information

BMS Study Director

Bristol-Myers Squibb

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