HIV Infection
Conditions
Keywords
HIV-1 infected pregnant women, either treatment naive or on ATV/RTV combined with ZDV/3TC
Brief summary
To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.
Interventions
DRUGAtazanavir + Ritonavir + Combivir
Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-infected pregnant women * \> 18 years of age * Between week 12 and 32 gestation * CD4 \> 200 cells/mm³ * Treatment-naive with HIV RNA \> 400 c/mL, on HAART with HIV RNA \<50 c/mL, or previously treated with ATV (\< 3 weeks) with HIV RNA\>400 c/mL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Gestational Age at Delivery | At the time of delivery | — |
| Infant Gender | At the time of delivery | — |
| Infant Race | At the time of delivery | — |
| Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum | Cmax = maximum observed plasma concentration of atazanavir at specified time points. |
| Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum | Cmax = maximum observed plasma concentration of ritonavir at specified time points. |
| Mean ATV Area Under the Concentration Curve (AUC TAU) | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum | AUC = area under the concentration curve (AUC \[TAU\]) of atazanavir in one dosing interval from time zero to 24 hours. |
| Mean RTV Area Under the Concentration Curve (AUC TAU) | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum | AUC = area under the concentration curve (AUC \[TAU\]) of ritonavir in one dosing interval. |
| Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose. | Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points. |
| Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose. | Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points. |
| Mean ATV Terminal Elimination Half Life (T 1/2) | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum | T 1/2 = terminal elimination half life of atazanavir at specified time points. |
| Mean RTV Terminal Elimination Half Life (T 1/2) | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum | T 1/2 = terminal elimination half life of ritonavir at specified time points. |
| Mean ATV Time of Maximum Observed Plasma Concentration (Tmax) | Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum | Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points. |
| Mean RTV Time of Maximum Observed Plasma Concentration (Tmax) | Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum | Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery | Day of Delivery ± 2 Days | The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5. |
| Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose | Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum | 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. |
| Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level | Baseline, Day of Delivery ± 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. |
| Mean HIV RNA Level at Baseline | Baseline | — |
| Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count | Baseline, Day of Delivery ± 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. |
| Mean CD4 Cell Count at Baseline | Baseline | — |
| Infant HIV Status | Birth Through 6 Months on Study | The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems). |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | During study period and 30 days post-study. | 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. |
| Number of Participants With Grade 2 to Grade 4 AEs and SAEs | During Study Period and 30 Days Post-Study. | 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 \[potentially life threatening\]). |
| SAEs in Enrolled Mothers | During Study Period and 30 Days Post-Study. | 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. |
| SAEs in Enrolled Infants | Birth Through Week 16 of Life | 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. |
| Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration | At Time of Delivery | Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery. |
| Median Infant Total Bilirubin Level | Birth (Day 1), Day 3, Day 5, and Day 7 of Life | Median infant total bilirubin level as measured at specified time points. |
| Mean Atazanavir Plasma Protein Binding | 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. |
Countries
Puerto Rico, South Africa, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Mother ATV 300 mg / RTV 100 mg Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart. | 20 |
| 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. | 21 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Pre-Natal Mothers | Discontinued ATV Before Delivery | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Mother ATV 300 mg / RTV 100 mg | Mother ATV 400 mg / RTV 100 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 21 Participants | 41 Participants |
| Age Continuous | 29 Years | 28 Years | 28 Years |
| HIV RNA Distribution at Baseline >= 100,000 | 1 c/mL | 1 c/mL | 2 c/mL |
| HIV RNA Distribution at Baseline 30,000 to < 100,000 | 3 c/mL | 6 c/mL | 9 c/mL |
| HIV RNA Distribution at Baseline <50 | 3 c/mL | 1 c/mL | 4 c/mL |
| HIV RNA Distribution at Baseline 50 to < 30,000 | 13 c/mL | 13 c/mL | 26 c/mL |
| Infant Gestational Age at Delivery | 38 Weeks | 38 Weeks | 38 Weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 19 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment Africa | 14 participants | 15 participants | 29 participants |
| Region of Enrollment North America | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 20 | 20 / 20 | 20 / 20 | 20 / 21 |
| serious Total, serious adverse events | 10 / 20 | 4 / 20 | 7 / 20 | 8 / 21 |
Outcome results
Primary
Infant Gender
Time frame: At the time of delivery
Population: All infants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Infant Gender | Male | 12 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Infant Gender | Female | 8 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Infant Gender | Male | 9 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Infant Gender | Female | 11 Participants |
Primary
Infant Gestational Age at Delivery
Time frame: At the time of delivery
Population: All infants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Infant Gestational Age at Delivery | 38 Weeks | Standard Error 0.3 |
| Mothers ATV 400 mg / RTV 100 mg | Infant Gestational Age at Delivery | 38 Weeks | Standard Error 0.3 |
Primary
Infant Race
Time frame: At the time of delivery
Population: All infants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Infant Race | Black | 15 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Infant Race | White | 5 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Infant Race | Mixed Race | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Infant Race | Black | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Infant Race | White | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Infant Race | Mixed Race | 1 Participants |
Primary
Mean ATV Area Under the Concentration Curve (AUC TAU)
AUC = area under the concentration curve (AUC \[TAU\]) of atazanavir in one dosing interval from time zero to 24 hours.
Time frame: Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum
Population: Treated participants in the PK concentration data set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean ATV Area Under the Concentration Curve (AUC TAU) | 34,399.13 ng•h / mL |
| Mothers ATV 400 mg / RTV 100 mg | Mean ATV Area Under the Concentration Curve (AUC TAU) | 34,251.50 ng•h / mL |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean ATV Area Under the Concentration Curve (AUC TAU) | 46,602.45 ng•h / mL |
Primary
Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval
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
Population: Treated participants in the pharmacokinetic (PK) concentration data set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval | 3,729.09 ng / mL |
| Mothers ATV 400 mg / RTV 100 mg | Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval | 3,291.46 ng / mL |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval | 4,210.76 ng / mL |
Primary
Mean ATV Terminal Elimination Half Life (T 1/2)
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
Population: Treated participants in the PK concentration data set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean ATV Terminal Elimination Half Life (T 1/2) | 10.42 Hours |
| Mothers ATV 400 mg / RTV 100 mg | Mean ATV Terminal Elimination Half Life (T 1/2) | 12.10 Hours |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean ATV Terminal Elimination Half Life (T 1/2) | 12.17 Hours |
Primary
Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)
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
Population: Treated participants in the PK concentration data set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean ATV Time of Maximum Observed Plasma Concentration (Tmax) | 3.68 Hours |
| Mothers ATV 400 mg / RTV 100 mg | Mean ATV Time of Maximum Observed Plasma Concentration (Tmax) | 2.94 Hours |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean ATV Time of Maximum Observed Plasma Concentration (Tmax) | 3.30 Hours |
Primary
Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose | 663.78 ng•h / mL |
| Mothers ATV 400 mg / RTV 100 mg | Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose | 668.48 ng•h / mL |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose | 916.63 ng•h / mL |
Primary
Mean RTV Area Under the Concentration Curve (AUC TAU)
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
Population: Treated participants in the PK concentration data set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean RTV Area Under the Concentration Curve (AUC TAU) | 4,500.03 ng•h / mL |
| Mothers ATV 400 mg / RTV 100 mg | Mean RTV Area Under the Concentration Curve (AUC TAU) | 4,664.93 ng•h / mL |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean RTV Area Under the Concentration Curve (AUC TAU) | 4,383.30 ng•h / mL |
Primary
Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval
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
Population: Treated participants in the PK concentration data set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval | 530.81 ng / mL |
| Mothers ATV 400 mg / RTV 100 mg | Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval | 587.36 ng / mL |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval | 524.48 ng / mL |
Primary
Mean RTV Terminal Elimination Half Life (T 1/2)
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
Population: Treated participants in the PK concentration data set
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean RTV Terminal Elimination Half Life (T 1/2) | 5.03 Hours |
| Mothers ATV 400 mg / RTV 100 mg | Mean RTV Terminal Elimination Half Life (T 1/2) | 5.28 Hours |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean RTV Terminal Elimination Half Life (T 1/2) | 5.10 Hours |
Primary
Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)
Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.
Time frame: Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum
Population: Treated participants in the PK concentration data set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean RTV Time of Maximum Observed Plasma Concentration (Tmax) | 6.11 Hours |
| Mothers ATV 400 mg / RTV 100 mg | Mean RTV Time of Maximum Observed Plasma Concentration (Tmax) | 4.15 Hours |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean RTV Time of Maximum Observed Plasma Concentration (Tmax) | 4.63 Hours |
Primary
Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose
Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose | 50.10 ng•h / mL |
| Mothers ATV 400 mg / RTV 100 mg | Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose | 41.12 ng•h / mL |
| Mothers ATV 400 mg / RTV 100 mg Third Trimester | Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose | 38.05 ng•h / mL |
Secondary
Infant HIV Status
The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems).
Time frame: Birth Through 6 Months on Study
Population: All infants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Infant HIV Status | HIV Positive | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Infant HIV Status | HIV Negative | 20 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Infant HIV Status | HIV Positive | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Infant HIV Status | HIV Negative | 20 Participants |
Secondary
Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery
The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery | HIV RNA < 400 copies/mL | 19 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery | HIV RNA < 50 copies/mL | 19 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery | HIV RNA < 400 copies/mL | 20 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery | HIV RNA < 50 copies/mL | 19 Participants |
Secondary
Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration
Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery.
Time frame: At Time of Delivery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration | Maternal Serum Concentration | 1,412.05 ng / mL | Standard Deviation 888.85 |
| Mothers ATV 300 mg / RTV 100 mg | Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration | Cord Blood Concentration | 273.20 ng / mL | Standard Deviation 182.04 |
| Mothers ATV 400 mg / RTV 100 mg | Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration | Cord Blood Concentration | 231.49 ng / mL | Standard Deviation 158.29 |
| Mothers ATV 400 mg / RTV 100 mg | Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration | Maternal Serum Concentration | 1,568.06 ng / mL | Standard Deviation 846.44 |
Secondary
Mean Atazanavir Plasma Protein Binding
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean Atazanavir Plasma Protein Binding | Third Trimester 3 Hours Post Dose (n = 20, 20) | 91.34 Percentage Bound | Standard Deviation 2.32 |
| Mothers ATV 300 mg / RTV 100 mg | Mean Atazanavir Plasma Protein Binding | Third Trimester 24 Hours Post Dose (n = 19, 20) | 90.37 Percentage Bound | Standard Deviation 2.58 |
| Mothers ATV 300 mg / RTV 100 mg | Mean Atazanavir Plasma Protein Binding | Time of Delivery (n = 15, 12) | 77.05 Percentage Bound | Standard Deviation 6.88 |
| Mothers ATV 400 mg / RTV 100 mg | Mean Atazanavir Plasma Protein Binding | Third Trimester 3 Hours Post Dose (n = 20, 20) | 87.70 Percentage Bound | Standard Deviation 2.69 |
| Mothers ATV 400 mg / RTV 100 mg | Mean Atazanavir Plasma Protein Binding | Third Trimester 24 Hours Post Dose (n = 19, 20) | 88.89 Percentage Bound | Standard Deviation 2.4 |
| Mothers ATV 400 mg / RTV 100 mg | Mean Atazanavir Plasma Protein Binding | Time of Delivery (n = 15, 12) | 75.62 Percentage Bound | Standard Deviation 4.34 |
Secondary
Mean CD4 Cell Count at Baseline
Time frame: Baseline
Population: All treated participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean CD4 Cell Count at Baseline | 435.0 cells / mm^3 | Standard Error 39.2 |
| Mothers ATV 400 mg / RTV 100 mg | Mean CD4 Cell Count at Baseline | 390.0 cells / mm^3 | Standard Error 25 |
Secondary
Mean HIV RNA Level at Baseline
Time frame: Baseline
Population: All treated participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Mean HIV RNA Level at Baseline | 3.520 log10 cm / mL | Standard Error 0.232 |
| Mothers ATV 400 mg / RTV 100 mg | Mean HIV RNA Level at Baseline | 4.020 log10 cm / mL | Standard Error 0.171 |
Secondary
Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count
The median CD4 cell count change from baseline was calculated for all treated mothers at the time of delivery ± 2 days. Maternal CD4 cell counts were assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count | 89 cells / mm^3 |
| Mothers ATV 400 mg / RTV 100 mg | Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count | 174 cells / mm^3 |
Secondary
Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level
The maternal HIV RNA level was determined at baseline and the day of delivery ± 2 days using VR-OC. The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level | -1.8 log10 c / mL |
| Mothers ATV 400 mg / RTV 100 mg | Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level | -2.37 log10 c / mL |
Secondary
Median Infant Total Bilirubin Level
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Median Infant Total Bilirubin Level | Day 1 (Birth) | 3.20 mg / dL |
| Mothers ATV 300 mg / RTV 100 mg | Median Infant Total Bilirubin Level | Day 3 | 8.40 mg / dL |
| Mothers ATV 300 mg / RTV 100 mg | Median Infant Total Bilirubin Level | Day 5 | 7.10 mg / dL |
| Mothers ATV 300 mg / RTV 100 mg | Median Infant Total Bilirubin Level | Day 7 | 5.10 mg / dL |
| Mothers ATV 400 mg / RTV 100 mg | Median Infant Total Bilirubin Level | Day 7 | 7.30 mg / dL |
| Mothers ATV 400 mg / RTV 100 mg | Median Infant Total Bilirubin Level | Day 1 (Birth) | 3.25 mg / dL |
| Mothers ATV 400 mg / RTV 100 mg | Median Infant Total Bilirubin Level | Day 5 | 9.25 mg / dL |
| Mothers ATV 400 mg / RTV 100 mg | Median Infant Total Bilirubin Level | Day 3 | 9.20 mg / dL |
Secondary
Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose
The MACS was administered to evaluate participant adherence to each drug and the adherence to the regimen. The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 17 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 17 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 17 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 17 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 8 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 8 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 9 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 9 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 5 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 4 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 13 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 13 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 13 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 13 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 20 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 20 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 19 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 19 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 15 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 15 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 15 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 15 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 18 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 19 Participants |
| Mothers ATV 400 mg / RTV 100 mg | 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) | 19 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE =any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious Adverse Event (n=41, n=40) | 16 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Diarrhea (n=41, n=40) | 4 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Transaminitis Discontinuation (n=41, n=40) | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Nausea (n=41, n=40) | 6 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Total AEs Leading to Discontinuation (n=41, n=40) | 2 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Vomiting (n=41, n=40) | 7 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Prematurity Causing Discontinuation (n=41, n=40) | NA Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Jaundice (n=41, n=40) | 10 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Death (n=41, n=40) | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Hyperbilirubinemia (n=41, n=40) | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | All AEs (n=41, n=40) | 40 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Ocular Icterus (n=41, n=40) | 3 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anemia Leading to Discontinuation (n=41, n=40) | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Skin / subcutaneous tissue disorders (n=41, n=40) | 10 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anemia (n=41, n=40) | 6 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Skin / subcutaneous tissue disorders (n=41, n=40) | 20 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious Adverse Event (n=41, n=40) | 14 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Total AEs Leading to Discontinuation (n=41, n=40) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anemia Leading to Discontinuation (n=41, n=40) | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Transaminitis Discontinuation (n=41, n=40) | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Prematurity Causing Discontinuation (n=41, n=40) | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | All AEs (n=41, n=40) | 40 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anemia (n=41, n=40) | 3 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Diarrhea (n=41, n=40) | 4 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Nausea (n=41, n=40) | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Vomiting (n=41, n=40) | 5 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Jaundice (n=41, n=40) | 20 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Hyperbilirubinemia (n=41, n=40) | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Ocular Icterus (n=41, n=40) | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Death (n=41, n=40) | 0 Participants |
Secondary
Number of Participants With Grade 2 to Grade 4 AEs and SAEs
AEs and SAEs considered possibly, probably, or certainly related to study treatment, were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). Hyperbilirubinemia (Grade 1=1.1 to 1.5 upper limit of normal \[ULN\] \[mild\], Grade 2=1.6 to 2.5 ULN \[moderate\], Grade 3=2.6 to 5.0 ULN \[severe\], Grade 4= \> 5.0 ULN \[potentially life threatening\]).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Grade 2 to Grade 4 AEs and SAEs | Grade 2 to Grade 4 (n=41, n=40) | 32 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Grade 2 to Grade 4 AEs and SAEs | Related Grade 2 to Grade 4 (n=41, n=40) | 10 Participants |
| Mothers ATV 300 mg / RTV 100 mg | Number of Participants With Grade 2 to Grade 4 AEs and SAEs | Grade 3 to Grade 4 (n=41, n=40) | 12 Participants |
| Mothers ATV 300 mg / RTV 100 mg | 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 |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Grade 2 to Grade 4 AEs and SAEs | Grade 3 to Grade 4 Total Bilirubin (n=41, n=40) | 7 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Grade 2 to Grade 4 AEs and SAEs | Grade 2 to Grade 4 (n=41, n=40) | 19 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Grade 2 to Grade 4 AEs and SAEs | Grade 3 to Grade 4 (n=41, n=40) | 8 Participants |
| Mothers ATV 400 mg / RTV 100 mg | Number of Participants With Grade 2 to Grade 4 AEs and SAEs | Related Grade 2 to Grade 4 (n=41, n=40) | 0 Participants |
Secondary
SAEs in 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.
Time frame: Birth Through Week 16 of Life
Population: SAEs were recorded for all enrolled infants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Sepsis | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Any Adverse Experience | 10 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Blood and Lymphatic System Disorders | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Anemia | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Cardiac Disorders | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Cardio-Respiratory Arrest | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Restrictive Cardiomyopathy | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Congenital, Familial, and Genetic Disorders | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Atrial Septal Defect | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Gastrointestinal Disorders | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Constipation | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Vomiting | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Hepatobiliary Disorders | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Hyperbilirubinemia | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Jaundice | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Infections and Infestations | 4 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Bronchiolitis | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Gastroenteritis | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Meningitis | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Pneumonia | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Syphilis | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Injury, Poisoning, and Procedural Complications | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Overdose | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Metabolism and Nutrition Disorders | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Hyperkalemia | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Hypoglycemia | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Nervous System Disorders | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Cerebral Ischemia | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Convulsion | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Pregnancy, Puerperium, and Perinatal Conditions | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Premature Baby | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Respiratory, Thoracic, and Mediastinal Disorders | 2 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Neonatal Respiratory Distress Syndrome | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Infants | Respiratory Distress | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Hypoglycemia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Syphilis | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Cardio-Respiratory Arrest | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Gastroenteritis | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Any Adverse Experience | 4 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Respiratory Distress | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Blood and Lymphatic System Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Meningitis | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Anemia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Nervous System Disorders | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Cardiac Disorders | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Pneumonia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Sepsis | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Restrictive Cardiomyopathy | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Premature Baby | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Congenital, Familial, and Genetic Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Cerebral Ischemia | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Atrial Septal Defect | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Injury, Poisoning, and Procedural Complications | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Gastrointestinal Disorders | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Neonatal Respiratory Distress Syndrome | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Constipation | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Overdose | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Vomiting | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Convulsion | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Hepatobiliary Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Metabolism and Nutrition Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Hyperbilirubinemia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Respiratory, Thoracic, and Mediastinal Disorders | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Jaundice | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Hyperkalemia | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Infections and Infestations | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Pregnancy, Puerperium, and Perinatal Conditions | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Infants | Bronchiolitis | 2 Participants |
Secondary
SAEs in Enrolled Mothers
SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.
Time frame: During Study Period and 30 Days Post-Study.
Population: Data were analyzed for all treated and untreated mothers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Amenorrhea | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Cardiomyopathy | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Hypertension | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Sinus Arrhythmia | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Transaminases Increased | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Pregnancy Induced Hypertension | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Gastrointestinal Disorders | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Hemorrhage | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Abdominal Hernia | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Pregnancy, Puerperium, and Perinatal Conditions | 2 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Hepatobiliary Disorders | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Any Adverse Experience | 7 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Hyperbilirubinemia | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Premature Rupture of Membranes | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Infections and Infestations | 2 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Blood and Lymphatic System Disorders | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Endometrial Decidual | 2 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Pre-eclampsia | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Pneumonia | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Anemia | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Sepsis | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Vascular Disorders | 1 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Investigations | 0 Participants |
| Mothers ATV 300 mg / RTV 100 mg | SAEs in Enrolled Mothers | Cardiac Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Investigations | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Pre-eclampsia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Pregnancy, Puerperium, and Perinatal Conditions | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Transaminases Increased | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Pregnancy Induced Hypertension | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Premature Rupture of Membranes | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Vascular Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Hypertension | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Hemorrhage | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Any Adverse Experience | 8 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Blood and Lymphatic System Disorders | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Anemia | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Cardiac Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Cardiomyopathy | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Sinus Arrhythmia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Gastrointestinal Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Abdominal Hernia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Hepatobiliary Disorders | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Hyperbilirubinemia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Infections and Infestations | 2 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Endometrial Decidual | 0 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Pneumonia | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Sepsis | 1 Participants |
| Mothers ATV 400 mg / RTV 100 mg | SAEs in Enrolled Mothers | Amenorrhea | 1 Participants |