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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00326716
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : April 7, 2011
Last Update Posted : November 16, 2011
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Intervention Drug: Atazanavir + Ritonavir + Combivir
Enrollment 69
Recruitment Details Pregnant participants were enrolled at 6 sites: United States (2), South Africa (3), and Puerto Rico (1).
Pre-assignment Details 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.
Arm/Group Title Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg Infants ATV 300 mg / RTV 100 mg Infants ATV 400 mg / RTV 100 mg
Hide Arm/Group Description 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. 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 born to mothers receiving treatment with ATV 300 mg / RTV 100 mg during the third trimester of pregnancy. Infants born to mothers receiving treatment with ATV 400 mg / RTV 100 mg during the third trimester of pregnancy.
Period Title: Pre-Natal Mothers
Started 20 21 0 0
Completed 19 [1] 19 [1] 0 [2] 0 [2]
Not Completed 1 2 0 0
Reason Not Completed
Discontinued ATV Before Delivery             1             2             0             0
[1]
Completion was defined as completing the study.
[2]
Completion was defined as completing all follow up visits through 6 months.
Period Title: Infants
Started 0 0 20 [1] 20 [2]
Completed 0 0 20 20
Not Completed 0 0 0 0
[1]
All infants were followed.
[2]
All infants were followed. One mother withdrew consent pre-delivery and her infant was not followed.
Arm/Group Title Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
21
 100.0%
41
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
29
(21 to 38)
28
(19 to 37)
28
(19 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
20
 100.0%
21
 100.0%
41
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
17
  85.0%
19
  90.5%
36
  87.8%
White
3
  15.0%
1
   4.8%
4
   9.8%
More than one race
0
   0.0%
1
   4.8%
1
   2.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
North America 6 6 12
Africa 14 15 29
HIV RNA Distribution at Baseline  
Measure Type: Number
Unit of measure:  c/mL
Number Analyzed 20 participants 21 participants 41 participants
<50 3 1 4
50 to < 30,000 13 13 26
30,000 to < 100,000 3 6 9
>= 100,000 1 1 2
Infant Gestational Age at Delivery  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 20 participants 21 participants 41 participants
38
(35 to 40)
38
(35 to 41)
38
(35 to 41)
1.Primary Outcome
Title Infant Gestational Age at Delivery
Hide Description [Not Specified]
Time Frame At the time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All infants.
Arm/Group Title Mothers ATV 300 mg / 100 mg Third Trimester Mothers ATV 400 mg / 100 mg Third Trimester
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: Weeks
38  (0.3) 38  (0.3)
2.Primary Outcome
Title Infant Gender
Hide Description [Not Specified]
Time Frame At the time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All infants.
Arm/Group Title Mothers ATV 300 mg / 100 mg Third Trimester Mothers ATV 400 mg / 100 mg Third Trimester
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
Male 12 9
Female 8 11
3.Primary Outcome
Title Infant Race
Hide Description [Not Specified]
Time Frame At the time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All infants.
Arm/Group Title Mothers ATV 300 mg / 100 mg Third Trimester Mothers ATV 400 mg / 100 mg Third Trimester
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
Black 15 18
White 5 1
Mixed Race 0 1
4.Primary Outcome
Title Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval
Hide Description Cmax = maximum observed plasma concentration of atazanavir at specified time points.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the pharmacokinetic (PK) concentration data set.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Second Trimester Mothers ATV 300 mg / RTV 100 mg Third Trimester Mothers ATV 400 mg / RTV 100 mg Third Trimester
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng / mL
3,729.09
(2,744.17 to 5,067.52)
3,291.46
(2,444.82 to 4,431.30)
4,210.76
(3,369.46 to 5,262.11)
5.Primary Outcome
Title Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval
Hide Description Cmax = maximum observed plasma concentration of ritonavir at specified time points.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Second Trimester Mothers ATV 300 mg / RTV 100 mg Third Trimester Mothers ATV 400 mg / RTV 100 mg Third Trimester
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng / mL
530.81
(333.20 to 845.61)
587.36
(423.55 to 814.52)
524.48
(368.76 to 745.95)
6.Primary Outcome
Title Mean ATV Area Under the Concentration Curve (AUC TAU)
Hide Description AUC = area under the concentration curve (AUC [TAU]) of atazanavir in one dosing interval from time zero to 24 hours.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Second Trimester Mothers ATV 300 mg / RTV 100 mg Third Trimester Mothers ATV 400 mg / RTV 100 mg Third Trimester
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng•h / mL
34,399.13
(25,975.68 to 45,554.15)
34,251.50
(27,173.69 to 43,172.84)
46,602.45
(36,445.75 to 59,589.63)
7.Primary Outcome
Title Mean RTV Area Under the Concentration Curve (AUC TAU)
Hide Description AUC = area under the concentration curve (AUC [TAU]) of ritonavir in one dosing interval.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Second Trimester Mothers ATV 300 mg / RTV 100 mg Third Trimester Mothers ATV 400 mg / RTV 100 mg Third Trimester
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng•h / mL
4,500.03
(3,243.97 to 6,242.43)
4,664.93
(3,670.14 to 5,929.35)
4,383.30
(3,107.41 to 6,183.06)
8.Primary Outcome
Title Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
Hide Description Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Second Trimester Mothers ATV 300 mg / RTV 100 mg Third Trimester Mothers ATV 400 mg / RTV 100 mg Third Trimester
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng•h / mL
663.78
(492.65 to 894.35)
668.48
(529.06 to 844.64)
916.63
(665.77 to 1,262.02)
9.Primary Outcome
Title Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
Hide Description Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Second Trimester Mothers ATV 300 mg / RTV 100 mg Third Trimester Mothers ATV 400 mg / RTV 100 mg Third Trimester
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng•h / mL
50.10
(28.39 to 88.43)
41.12
(29.06 to 58.21)
38.05
(26.24 to 55.17)
10.Primary Outcome
Title Mean ATV Terminal Elimination Half Life (T 1/2)
Hide Description T 1/2 = terminal elimination half life of atazanavir at specified time points.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set.
Arm/Group Title Mothers ATV 300 mg / 100 mg Second Trimester Mothers ATV 300 mg / 100 mg Third Trimester Mothers ATV 400 mg / 100 mg Third Trimester
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hours
10.42
(9.14 to 11.89)
12.10
(9.44 to 15.51)
12.17
(10.42 to 14.21)
11.Primary Outcome
Title Mean RTV Terminal Elimination Half Life (T 1/2)
Hide Description T 1/2 = terminal elimination half life of ritonavir at specified time points.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set
Arm/Group Title Mothers ATV 300 mg / 100 mg Second Trimester Mothers ATV 300 mg / 100 mg Third Trimester Mothers ATV 400 mg / 100 mg Third Trimester
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hours
5.03
(4.51 to 5.60)
5.28
(4.73 to 5.90)
5.10
(4.30 to 6.05)
12.Primary Outcome
Title Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)
Hide Description Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.
Time Frame Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set.
Arm/Group Title Mothers ATV 300 mg / 100 mg Second Trimester Mothers ATV 300 mg / 100 mg Third Trimester Mothers ATV 400 mg / 100 mg Third Trimester
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hours
3.68
(2.92 to 4.64)
2.94
(2.36 to 3.65)
3.30
(2.57 to 4.23)
13.Primary Outcome
Title Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)
Hide Description Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.
Time Frame Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the PK concentration data set.
Arm/Group Title Mothers ATV 300 mg / 100 mg Second Trimester Mothers ATV 300 mg / 100 mg Third Trimester Mothers ATV 400 mg / 100 mg Third Trimester
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 9 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hours
6.11
(3.81 to 9.80)
4.15
(3.12 to 5.54)
4.63
(3.45 to 6.19)
14.Secondary Outcome
Title Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery
Hide Description The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.
Time Frame Day of Delivery ± 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Mothers ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: Participants
HIV RNA < 400 copies/mL 19 20
HIV RNA < 50 copies/mL 19 19
15.Secondary Outcome
Title Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level
Hide Description 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.
Time Frame Baseline, Day of Delivery ± 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 19
Median (Inter-Quartile Range)
Unit of Measure: log10 c / mL
-1.8
(-2.43 to -1.39)
-2.37
(-2.93 to -1.81)
16.Secondary Outcome
Title Mean HIV RNA Level at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Third Trimester Mothers ATV 400 mg / RTV 100 mg Third Trimester
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 21
Mean (Standard Error)
Unit of Measure: log10 cm / mL
3.520  (0.232) 4.020  (0.171)
17.Secondary Outcome
Title Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count
Hide Description 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.
Time Frame Baseline, Day of Delivery ± 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 20
Median (Inter-Quartile Range)
Unit of Measure: cells / mm^3
89
(-75 to 213)
174
(-39 to 257)
18.Secondary Outcome
Title Mean CD4 Cell Count at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Third Trimester Mothers ATV 400 mg / RTV 100 mg Third Trimester
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 21
Mean (Standard Error)
Unit of Measure: cells / mm^3
435.0  (39.2) 390.0  (25.0)
19.Secondary Outcome
Title Infant HIV Status
Hide Description The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems).
Time Frame Birth Through 6 Months on Study
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Hide Analysis Population Description
All infants.
Arm/Group Title Infant ATV 300 mg / RTV 100 mg Infant ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
HIV Positive 0 0
HIV Negative 20 20
20.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame During study period and 30 days post-study.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Treated Mothers All Infants
Hide Arm/Group Description:
Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: Participants
Death (n=41, n=40) 0 0
Serious Adverse Event (n=41, n=40) 16 14
Total AEs Leading to Discontinuation (n=41, n=40) 2 2
Anemia Leading to Discontinuation (n=41, n=40) 1 2
Transaminitis Discontinuation (n=41, n=40) 1 0
Prematurity Causing Discontinuation (n=41, n=40) NA [1]  1
All AEs (n=41, n=40) 40 40
Anemia (n=41, n=40) 6 3
Diarrhea (n=41, n=40) 4 4
Nausea (n=41, n=40) 6 0
Vomiting (n=41, n=40) 7 5
Jaundice (n=41, n=40) 10 20
Hyperbilirubinemia (n=41, n=40) 1 1
Ocular Icterus (n=41, n=40) 3 0
Skin / subcutaneous tissue disorders (n=41, n=40) 10 20
[1]
Prematurity causing discontinuation was considered an infant only AE/SAE and thus was not deemed appropriate for evaluation in the mothers only population.
21.Secondary Outcome
Title Number of Participants With Grade 2 to Grade 4 AEs and SAEs
Hide Description 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]).
Time Frame During Study Period and 30 Days Post-Study.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Treated Mothers All Infants
Hide Arm/Group Description:
Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: Participants
Grade 2 to Grade 4 (n=41, n=40) 32 19
Related Grade 2 to Grade 4 (n=41, n=40) 10 0
Grade 3 to Grade 4 (n=41, n=40) 12 8
Grade 3 to Grade 4 Total Bilirubin (n=41, n=40) 19 7
22.Secondary Outcome
Title SAEs in Enrolled Mothers
Hide Description 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.
Time Frame During Study Period and 30 Days Post-Study.
Hide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed for all treated and untreated mothers.
Arm/Group Title Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 21
Measure Type: Number
Unit of Measure: Participants
Any Adverse Experience 7 8
Blood and Lymphatic System Disorders 1 2
Anemia 1 2
Cardiac Disorders 1 1
Cardiomyopathy 1 0
Sinus Arrhythmia 0 1
Gastrointestinal Disorders 0 1
Abdominal Hernia 0 1
Hepatobiliary Disorders 0 1
Hyperbilirubinemia 0 1
Infections and Infestations 2 2
Endometrial Decidual 2 0
Pneumonia 0 1
Sepsis 0 1
Investigations 0 1
Transaminases Increased 0 1
Pregnancy, Puerperium, and Perinatal Conditions 2 2
Amenorrhea 0 1
Pre-eclampsia 1 1
Pregnancy Induced Hypertension 0 0
Premature Rupture of Membranes 1 0
Vascular Disorders 1 1
Hypertension 0 1
Hemorrhage 1 0
23.Secondary Outcome
Title SAEs in Enrolled Infants
Hide Description 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.
Time Frame Birth Through Week 16 of Life
Hide Outcome Measure Data
Hide Analysis Population Description
SAEs were recorded for all enrolled infants.
Arm/Group Title Infant ATV 300 mg / RTV 100 mg Infant ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
Any Adverse Experience 10 4
Blood and Lymphatic System Disorders 1 1
Anemia 1 1
Cardiac Disorders 1 0
Cardio-Respiratory Arrest 1 0
Restrictive Cardiomyopathy 1 0
Congenital, Familial, and Genetic Disorders 0 1
Atrial Septal Defect 0 1
Gastrointestinal Disorders 1 0
Constipation 1 0
Vomiting 1 0
Hepatobiliary Disorders 1 1
Hyperbilirubinemia 0 1
Jaundice 1 0
Infections and Infestations 4 2
Bronchiolitis 0 2
Gastroenteritis 1 0
Meningitis 1 0
Pneumonia 0 1
Sepsis 1 0
Syphilis 1 0
Injury, Poisoning, and Procedural Complications 1 0
Overdose 1 0
Metabolism and Nutrition Disorders 1 1
Hyperkalemia 1 0
Hypoglycemia 0 1
Nervous System Disorders 1 0
Cerebral Ischemia 1 0
Convulsion 1 0
Pregnancy, Puerperium, and Perinatal Conditions 1 1
Premature Baby 1 1
Respiratory, Thoracic, and Mediastinal Disorders 2 0
Neonatal Respiratory Distress Syndrome 1 0
Respiratory Distress 1 0
24.Secondary Outcome
Title Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration
Hide Description Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery.
Time Frame At Time of Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mothers ATV 300 mg / RTV 100 mg Mothers ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: ng / mL
Maternal Serum Concentration 1,412.05  (888.85) 1,568.06  (846.44)
Cord Blood Concentration 273.20  (182.04) 231.49  (158.29)
25.Secondary Outcome
Title Median Infant Total Bilirubin Level
Hide Description Median infant total bilirubin level as measured at specified time points.
Time Frame Birth (Day 1), Day 3, Day 5, and Day 7 of Life
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infant ATV 300 mg / RTV 100 mg Infant ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: mg / dL
Day 1 (Birth)
3.20
(2.80 to 4.30)
3.25
(2.80 to 4.40)
Day 3
8.40
(5.40 to 11.30)
9.20
(7.00 to 9.60)
Day 5
7.10
(3.05 to 10.20)
9.25
(5.50 to 10.45)
Day 7
5.10
(1.90 to 8.90)
7.30
(2.50 to 9.30)
26.Secondary Outcome
Title Mean Atazanavir Plasma Protein Binding
Hide Description Atazanavir Plasma Protein Binding Percentage measured at specified time points.
Time Frame Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: Percentage Bound
Third Trimester 3 Hours Post Dose (n = 20, 20) 91.34  (2.32) 87.70  (2.69)
Third Trimester 24 Hours Post Dose (n = 19, 20) 90.37  (2.58) 88.89  (2.40)
Time of Delivery (n = 15, 12) 77.05  (6.88) 75.62  (4.34)
27.Secondary Outcome
Title Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
Hide Description 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.
Time Frame Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in this evaluation.
Arm/Group Title Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 21
Measure Type: Number
Unit of Measure: Participants
Study Week 2 Regimen (n = 20,18) 20 17
Study Week 2 ATV (n = 20,18) 20 17
Study Week 2 RTV (n = 20,18) 20 17
Study Week 2 ZDV/3TC (n = 20,18) 20 17
Visit 1 Pregnancy Week 20 to 28 Regimen (n=12, 9) 11 8
Visit 1 Pregnancy Week 20 to 28 ATV (n=12, 9) 12 8
Visit 1 Pregnancy Week 20 to 28 RTV (n=12, 9) 12 9
Visit 1 Pregnancy Week 20 to 28 ZDV/3TC (n=12, 9) 11 9
Visit 2 Pregnancy Week 20 to 28 Regimen (n=8, 5) 3 3
Visit 2 Pregnancy Week 20 to 28 ATV (n=8, 5) 8 5
Visit 2 Pregnancy Week 20 to 28 RTV (n=8, 5) 7 4
Visit 2 Pregnancy Week 20 to 28 ZDV/3TC (n=8, 5) 4 4
Visit 3 Pregnancy Week 20 to 28 Regimen (n=6, 2) 4 2
Visit 3 Pregnancy Week 20 to 28 ATV (n=6, 2) 5 2
Visit 3 Pregnancy Week 20 to 28 RTV (n=6, 2) 5 2
Visit 3 Pregnancy Week 20 to 28 ADV/3TC (n=6, 2) 4 2
Visit 4 Pregnancy Wk 20 to 28 Regimen (n=0, 13) NA [1]  13
Visit 4 Pregnancy Week 20 to 28 ATV (n=0, 13) NA [1]  13
Visit 4 Pregnancy Week 20 to 28 RTV (n=0, 13) NA [1]  13
Visit 4 Pregnancy Wk 20 to 28 ZDV/3TC (n=0, 13) NA [1]  13
Visit 1 Pregnancy Wk 20 to Birth Regimen (n=20,20) 19 20
Visit 1 Pregnancy Week 20 to Birth ATV (n=20,20) 20 20
Visit 1 Pregnancy Week 20 to Birth RTV (n=20,20) 20 20
Visit 1 Pregnancy Wk 20 to Birth ZDV/3TC (n=20,20) 19 20
Visit 2 Pregnancy Wk 20 to Birth Regimen (n=19,19) 18 18
Visit 2 Pregnancy Week 20 to Birth ATV (n=19,19) 19 19
Visit 2 Pregnancy Week 20 to Birth RTV (n=19,19) 19 19
Visit 2 Pregnancy Wk 20 to Birth ZDV/3TC (n=19,19) 18 18
Visit 3 Pregnancy Wk 20 to Birth Regimen (n=15,19) 12 18
Visit 3 Pregnancy Week 20 to Birth ATV (n=15,19) 13 19
Visit 3 Pregnancy Week 20 to Birth RTV (n=15,19) 13 19
Visit 3 Pregnancy Wk 20 to Birth ZDV/3TC (n=15,19) 12 18
Visit 4 Pregnancy Wk 28 to Birth Regimen (n=5,15) 5 15
Visit 4 Pregnancy Week 28 to Birth ATV (n=5,15) 5 15
Visit 4 Pregnancy Week 28 to Birth RTV (n=5,15) 5 15
Visit 4 Pregnancy Wk 28 to Birth ZDV/3TC (n=5,15) 5 15
Visit 5 Pregnancy Wk 28 to Birth Regimen (n=1, 2) 1 2
Visit 5 Pregnancy Week 28 to Birth ATV (n=1, 2) 1 2
Visit 5 Pregnancy Week 28 to Birth RTV (n=1, 2) 1 2
Visit 5 Pregnancy Wk 28 to Birth ZDV/3TC (n=1, 2) 1 2
Visit 6 Pregnancy Wk 28 to Birth Regimen (n=0, 1) NA [2]  1
Visit 6 Pregnancy Week 28 to Birth ATV (n=0, 1) NA [2]  1
Visit 6 Pregnancy Week 28 to Birth RTV (n=0, 1) NA [2]  1
Visit 6 Pregnancy Wk 28 to Birth ZDV/3TC (n=0, 1) NA [2]  1
Postpartum Week 2 Regimen (n=19, 19) 14 18
Postpartum Week 2 ATV (n=18, 19) 16 18
Postpartum Week 2 RTV (n=18, 19) 16 18
Postpartum Week 2 ZDV/3TC (n =19, 19) 14 18
Postpartum Week 4 Regimen (n=17, 19) 16 18
Postpartum Week 4 ATV (n=17, 19) 17 19
Postpartum Week 4 RTV (n=17, 19) 16 19
Postpartum Week 4 ZDV/3TC (n=17, 19) 17 18
[1]
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.
[2]
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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infant ATV 300 mg / RTV 100 mg Infant ATV 400 mg / RTV 100 mg Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Hide Arm/Group Description Infants of mothers taking ATV 300 mg / RTV 100 mg at birth. Infants of mothers taking ATV 400 mg / RTV 100 mg at birth. 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. 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.
All-Cause Mortality
Infant ATV 300 mg / RTV 100 mg Infant ATV 400 mg / RTV 100 mg Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Infant ATV 300 mg / RTV 100 mg Infant ATV 400 mg / RTV 100 mg Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/20 (50.00%)   4/20 (20.00%)   7/20 (35.00%)   8/21 (38.10%) 
Blood and lymphatic system disorders         
ANAEMIA  1  1/20 (5.00%)  1/20 (5.00%)  1/20 (5.00%)  2/21 (9.52%) 
Cardiac disorders         
CARDIOMYOPATHY  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
SINUS ARRHYTHMIA  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
CARDIO-RESPIRATORY ARREST  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
RESTRICTIVE CARDIOMYOPATHY  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Congenital, familial and genetic disorders         
ATRIAL SEPTAL DEFECT  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Gastrointestinal disorders         
VOMITING  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
CONSTIPATION  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
ABDOMINAL HERNIA  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Hepatobiliary disorders         
JAUNDICE  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
HYPERBILIRUBINAEMIA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
Infections and infestations         
SEPSIS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
SYPHILIS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
PNEUMONIA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
MENINGITIS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
BRONCHIOLITIS  1  0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/21 (0.00%) 
GASTROENTERITIS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
ENDOMETRITIS DECIDUAL  1  0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications         
OVERDOSE  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Investigations         
TRANSAMINASES INCREASED  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Metabolism and nutrition disorders         
HYPERKALAEMIA  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
HYPOGLYCAEMIA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Nervous system disorders         
CONVULSION  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
CEREBRAL ISCHAEMIA  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
AMNIORRHOEA  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
PRE-ECLAMPSIA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
PREMATURE BABY  1  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
PREMATURE RUPTURE OF MEMBRANES  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
RESPIRATORY DISTRESS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
NEONATAL RESPIRATORY DISTRESS SYNDROME  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Vascular disorders         
HAEMORRHAGE  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
HYPERTENSION  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infant ATV 300 mg / RTV 100 mg Infant ATV 400 mg / RTV 100 mg Mother ATV 300 mg / RTV 100 mg Mother ATV 400 mg / RTV 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/20 (100.00%)   20/20 (100.00%)   20/20 (100.00%)   20/21 (95.24%) 
Blood and lymphatic system disorders         
ANAEMIA  1  1/20 (5.00%)  1/20 (5.00%)  2/20 (10.00%)  4/21 (19.05%) 
LYMPHADENOPATHY  1  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Congenital, familial and genetic disorders         
HYDROCELE  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
CONGENITAL NAEVUS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
ATRIAL SEPTAL DEFECT  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Eye disorders         
CONJUNCTIVITIS  1  3/20 (15.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
OCULAR ICTERUS  1  0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  1/21 (4.76%) 
CONJUNCTIVAL HAEMORRHAGE  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Gastrointestinal disorders         
NAUSEA  1  0/20 (0.00%)  0/20 (0.00%)  4/20 (20.00%)  2/21 (9.52%) 
VOMITING  1  1/20 (5.00%)  3/20 (15.00%)  5/20 (25.00%)  2/21 (9.52%) 
DIARRHOEA  1  1/20 (5.00%)  3/20 (15.00%)  3/20 (15.00%)  1/21 (4.76%) 
DYSPEPSIA  1  0/20 (0.00%)  0/20 (0.00%)  3/20 (15.00%)  2/21 (9.52%) 
TOOTHACHE  1  0/20 (0.00%)  0/20 (0.00%)  3/20 (15.00%)  1/21 (4.76%) 
CONSTIPATION  1  1/20 (5.00%)  3/20 (15.00%)  2/20 (10.00%)  1/21 (4.76%) 
ABDOMINAL PAIN  1  1/20 (5.00%)  2/20 (10.00%)  2/20 (10.00%)  1/21 (4.76%) 
ABDOMINAL HERNIA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
MOUTH ULCERATION  1  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
UMBILICAL HERNIA  1  2/20 (10.00%)  3/20 (15.00%)  0/20 (0.00%)  0/21 (0.00%) 
TONGUE GEOGRAPHIC  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
RECTAL HAEMORRHAGE  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
ABDOMINAL DISTENSION  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
ABDOMINAL PAIN LOWER  1  0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/21 (0.00%) 
PAROTID GLAND ENLARGEMENT  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/20 (5.00%)  4/20 (20.00%)  1/20 (5.00%)  0/21 (0.00%) 
General disorders         
MASS  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
PAIN  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
FATIGUE  1  0/20 (0.00%)  0/20 (0.00%)  4/20 (20.00%)  0/21 (0.00%) 
PYREXIA  1  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
OEDEMA PERIPHERAL  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  2/21 (9.52%) 
Hepatobiliary disorders         
JAUNDICE  1  9/20 (45.00%)  10/20 (50.00%)  4/20 (20.00%)  6/21 (28.57%) 
HEPATOMEGALY  1  0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/21 (0.00%) 
Infections and infestations         
IMPETIGO  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
MASTITIS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
RHINITIS  1  0/20 (0.00%)  3/20 (15.00%)  0/20 (0.00%)  2/21 (9.52%) 
INFLUENZA  1  0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  2/21 (9.52%) 
SINUSITIS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
BODY TINEA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
BRONCHITIS  1  2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%)  3/21 (14.29%) 
TRACHEITIS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
CANDIDIASIS  1  1/20 (5.00%)  2/20 (10.00%)  0/20 (0.00%)  0/21 (0.00%) 
ORAL HERPES  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
PHARYNGITIS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
TONSILLITIS  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/21 (9.52%) 
ENDOMETRITIS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
OTITIS MEDIA  1  3/20 (15.00%)  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
SKIN CANDIDA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
WOUND SEPSIS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
BRONCHIOLITIS  1  2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
HERPES ZOSTER  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
GASTROENTERITIS  1  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
NASOPHARYNGITIS  1  0/20 (0.00%)  1/20 (5.00%)  2/20 (10.00%)  1/21 (4.76%) 
VIRAL INFECTION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
WOUND INFECTION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
ORAL CANDIDIASIS  1  3/20 (15.00%)  3/20 (15.00%)  2/20 (10.00%)  0/21 (0.00%) 
VAGINAL INFECTION  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/21 (9.52%) 
VAGINITIS BACTERIAL  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
FUNGAL SKIN INFECTION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
URINARY TRACT INFECTION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  6/21 (28.57%) 
SKIN BACTERIAL INFECTION  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
VULVOVAGINAL CANDIDIASIS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
LOWER RESPIRATORY TRACT INFECTION  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  4/20 (20.00%)  10/20 (50.00%)  8/20 (40.00%)  4/21 (19.05%) 
Injury, poisoning and procedural complications         
OVERDOSE  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
ARTHROPOD BITE  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
PROCEDURAL PAIN  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
SKIN LACERATION  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
VACCINATION COMPLICATION  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Investigations         
CARDIAC MURMUR  1  0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/21 (0.00%) 
WEIGHT DECREASED  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
HAEMOGLOBIN DECREASED  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
CULTURE URINE POSITIVE  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
WHITE BLOOD CELLS URINE POSITIVE  1  0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/21 (0.00%) 
ELECTROCARDIOGRAM T WAVE INVERSION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders         
ANOREXIA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
HYPOGLYCAEMIA  1  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
DECREASED APPETITE  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
GESTATIONAL DIABETES  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders         
BURSITIS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
BACK PAIN  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
ARTHRALGIA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
JOINT STIFFNESS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
JOINT HYPEREXTENSION  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Nervous system disorders         
SYNCOPE  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
HEADACHE  1  0/20 (0.00%)  0/20 (0.00%)  7/20 (35.00%)  2/21 (9.52%) 
SCIATICA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
DIZZINESS  1  0/20 (0.00%)  0/20 (0.00%)  3/20 (15.00%)  1/21 (4.76%) 
POST HERPETIC NEURALGIA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
PREMATURE LABOUR  1  0/20 (0.00%)  0/20 (0.00%)  3/20 (15.00%)  1/21 (4.76%) 
PROLONGED LABOUR  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
CAPUT SUCCEDANEUM  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
JAUNDICE NEONATAL  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
NEONATAL DISORDER  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
FOETAL DISTRESS SYNDROME  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
PREGNANCY INDUCED HYPERTENSION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
PREMATURE RUPTURE OF MEMBRANES  1  0/20 (0.00%)  0/20 (0.00%)  4/20 (20.00%)  1/21 (4.76%) 
Psychiatric disorders         
DEPRESSION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Renal and urinary disorders         
DYSURIA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
PROTEINURIA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Reproductive system and breast disorders         
PELVIC PAIN  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
VAGINAL DISCHARGE  1  0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  2/21 (9.52%) 
VAGINAL HAEMORRHAGE  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  5/20 (25.00%)  0/20 (0.00%)  4/20 (20.00%)  3/21 (14.29%) 
DYSPNOEA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
SNEEZING  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
EPISTAXIS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
TACHYPNOEA  1  0/20 (0.00%)  3/20 (15.00%)  0/20 (0.00%)  0/21 (0.00%) 
RHINORRHOEA  1  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
NASAL CONGESTION  1  7/20 (35.00%)  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
SINUS CONGESTION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
NOCTURNAL DYSPNOEA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
OROPHARYNGEAL PAIN  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
RESPIRATORY DISTRESS  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders         
RASH  1  3/20 (15.00%)  4/20 (20.00%)  1/20 (5.00%)  3/21 (14.29%) 
ECZEMA  1  2/20 (10.00%)  3/20 (15.00%)  1/20 (5.00%)  1/21 (4.76%) 
DRY SKIN  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
PRURITUS  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  3/21 (14.29%) 
HEAT RASH  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
PETECHIAE  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
DERMATITIS  1  2/20 (10.00%)  2/20 (10.00%)  0/20 (0.00%)  0/21 (0.00%) 
SEBORRHOEA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
RASH MACULAR  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
RASH GENERALISED  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
DERMATITIS DIAPER  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
NAIL PIGMENTATION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
DERMATITIS ALLERGIC  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
NAIL DISCOLOURATION  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
SEBORRHOEIC DERMATITIS  1  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Vascular disorders         
HYPERTENSION  1  0/20 (0.00%)  0/20 (0.00%)  3/20 (15.00%)  3/21 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: clinical.trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00326716    
Other Study ID Numbers: AI424-182
First Submitted: May 15, 2006
First Posted: May 17, 2006
Results First Submitted: January 5, 2011
Results First Posted: April 7, 2011
Last Update Posted: November 16, 2011