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A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

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ClinicalTrials.gov Identifier: NCT00855335
Recruitment Status : Completed
First Posted : March 4, 2009
Results First Posted : September 15, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Pregnancy
Interventions Drug: Darunavir
Drug: Ritonavir
Drug: Etravirine
Drug: Rilpivirine
Drug: Darunavir/Cobicistat (FDC)
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Darunavir 600 mg /Ritonavir 100 mg Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Hide Arm/Group Description Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum. Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum. Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum. Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum. Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Period Title: Overall Study
Started 18 18 15 19 7
Completed 13 16 10 12 6
Not Completed 5 2 5 7 1
Reason Not Completed
Lost to Follow-up             0             0             3             1             0
Withdrawal by Subject             0             0             0             1             0
Adverse Event             2             0             0             0             0
Physician Decision             1             1             0             0             0
Other             2             1             2             5             1
Arm/Group Title Darunavir 600 mg /Ritonavir 100 mg Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily Total
Hide Arm/Group Description Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum. Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum. Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum. Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum. Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum. Total of all reporting groups
Overall Number of Baseline Participants 18 18 15 19 7 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 15 participants 19 participants 7 participants 77 participants
25.7  (5.6) 24.2  (3.45) 26.3  (4.91) 27.2  (4.51) 28.86  (4.71) 26.1  (4.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 15 participants 19 participants 7 participants 77 participants
Female
18
 100.0%
18
 100.0%
15
 100.0%
19
 100.0%
7
 100.0%
77
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 15 participants 19 participants 7 participants 77 participants
18
 100.0%
18
 100.0%
15
 100.0%
19
 100.0%
7
 100.0%
77
 100.0%
1.Primary Outcome
Title Predose (Trough) Plasma Concentration (C0h)
Hide Description C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.
Time Frame Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 12 13 17 17 13 15 7 7
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Postpartum (6-12 W) Number Analyzed 12 participants 12 participants 16 participants 16 participants 10 participants 11 participants 6 participants 7 participants
3608  (2812) 491.4  (472.4) 2481  (2183) 147  (198) 281  (193) 127  (97.0) 2811  (2296) 134  (145)
2nd Trimester Number Analyzed 12 participants 13 participants 17 participants 17 participants 13 participants 15 participants 7 participants 7 participants
2323  (1140) 225.9  (127.5) 1793  (964) 94.2  (102) 439  (212) 75.6  (36.2) 540  (803) NA [1]   (NA)
3rd Trimester Number Analyzed 12 participants 12 participants 15 participants 15 participants 10 participants 13 participants 6 participants 6 participants
3280  (1466) 236.0  (108.08) 1528  (1184) 74.6  (90.2) 413  (78.2) 78.0  (39.1) 824  (630) 30.1  (51.5)
[1]
Here, NA indicates that the data is not reported because the predose plasma concentrations were Below Quantification Limit (BQL) less than (<) 5.00 ng/mL.
2.Primary Outcome
Title Minimum Plasma Concentration (Cmin)
Hide Description The Cmin is the minimum observed plasma concentration.
Time Frame Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 12 13 17 17 13 15 7 7
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Postpartum (6-12 W) Number Analyzed 12 participants 12 participants 16 participants 16 participants 10 participants 11 participants 6 participants 6 participants
2851  (2216) 264.7  (259.8) 1473  (1141) 40.5  (31.4) 269  (182) 84.0  (58.8) 1538  (1344) 41.4  (49.1)
2nd Trimester Number Analyzed 12 participants 13 participants 17 participants 17 participants 13 participants 15 participants 7 participants 7 participants
1922  (825) 141.1  (73.78) 1248  (542) 32.2  (19.8) 383  (210) 54.3  (25.8) 168  (149) NA [1]   (NA)
3rd Trimester Number Analyzed 12 participants 11 participants 15 participants 15 participants 10 participants 13 participants 6 participants 6 participants
2661  (1269) 148.1  (52.26) 1075  (594) 28.0  (20.5) 349  (103) 52.9  (24.4) 184  (99.0) NA [1]   (NA)
[1]
Here, NA indicates that the data is not reported because the plasma concentrations were BQL (< 5.00 ng/mL).
3.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description The Cmax is the maximum observed plasma concentration.
Time Frame Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 12 13 17 17 13 15 7 7
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Postpartum (6-12 W) Number Analyzed 12 participants 12 participants 16 participants 16 participants 10 participants 11 participants 6 participants 6 participants
6659  (2364) 1110  (901.2) 7310  (1704) 742  (335) 569  (261) 167  (101) 7918  (2199) 996  (323)
2nd Trimester Number Analyzed 12 participants 13 participants 17 participants 17 participants 13 participants 15 participants 7 participants 7 participants
4668  (1097) 546.8  (249.4) 4964  (1505) 439  (241) 774  (300) 121  (45.9) 4340  (1616) 571  (350)
3rd Trimester Number Analyzed 12 participants 12 participants 15 participants 15 participants 10 participants 13 participants 6 participants 6 participants
5328  (1631) 536.1  (210.6) 5132  (1198) 397  (184) 785  (238) 123  (47.5) 4910  (970) 759  (366)
4.Primary Outcome
Title Time to Reach the Maximum Plasma Concentration (Tmax)
Hide Description The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Time Frame Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 12 13 17 17 13 15 7 7
Median (Full Range)
Unit of Measure: hour (h)
Postpartum (6-12 W) Number Analyzed 12 participants 12 participants 16 participants 16 participants 10 participants 11 participants 6 participants 6 participants
3.00
(1.00 to 6.00)
5.04
(1.02 to 12.08)
4.00
(1.00 to 6.00)
4.18
(2.02 to 6.03)
4.00
(1.00 to 9.00)
4.00
(2.03 to 25.08)
4.00
(2.00 to 6.00)
4.00
(2.00 to 4.00)
2nd Trimester Number Analyzed 12 participants 13 participants 17 participants 17 participants 13 participants 15 participants 7 participants 7 participants
3.00
(0.93 to 5.83)
4.17
(0.93 to 6.08)
4.00
(3.00 to 6.08)
5.92
(2.03 to 6.10)
3.05
(2.00 to 4.00)
4.00
(1.00 to 9.00)
4.00
(3.00 to 6.00)
4.03
(2.00 to 6.00)
3rd Trimester Number Analyzed 12 participants 12 participants 15 participants 15 participants 10 participants 13 participants 6 participants 6 participants
3.00
(1.00 to 11.88)
4.07
(1.00 to 9.10)
3.05
(1.00 to 6.00)
6.00
(2.02 to 6.02)
3.00
(2.00 to 6.00)
4.00
(2.00 to 24.93)
3.50
(2.00 to 6.00)
3.50
(2.00 to 4.00)
5.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h)
Hide Description The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours post dose. The selected arms were based on the dosing frequency (twice daily).
Time Frame Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Etravirine 200 mg Twice Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 12 12 13
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
Postpartum (6-12 W) Number Analyzed 12 participants 12 participants 10 participants
56890  (26340) 7406  (6188) 5004  (2521)
2nd Trimester Number Analyzed 11 participants 12 participants 13 participants
39370  (9597) 3775  (1265) 6617  (2766)
3rd Trimester Number Analyzed 12 participants 12 participants 9 participants
45880  (17360) 3750  (1336) 6846  (1482)
6.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h)
Hide Description The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post dose. The selected arms were based on the dosing frequency (once daily).
Time Frame Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily
Hide Arm/Group Description:
Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 17 17 15 7 7
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
Postpartum (6-12 W) Number Analyzed 16 participants 16 participants 11 participants 6 participants 6 participants
92116  (29241) 6584  (2861) 2714  (1535) 99613  (34862) 8643  (3187)
2nd trimester Number Analyzed 17 participants 17 participants 15 participants 7 participants 7 participants
62289  (16234) 3935  (2063) 1792  (711) 47293  (19058) 3862  (2703)
3rd trimester Number Analyzed 15 participants 15 participants 13 participants 6 participants 6 participants
61112  (13790) 3821  (1723) 1762  (662) 47991  (9879) 4736  (2917)
7.Secondary Outcome
Title Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL)
Hide Description Number of participants were assessed with a viral load (VL) lesser than (<) 50 HIV-1 RNA copies/ mL over time.
Time Frame Up to postpartum (6-12 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 600 mg /Ritonavir 100 Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 16 17 13 19 6
Measure Type: Number
Unit of Measure: Participants
2nd trimester Less than(<)50 copies/milliLiter(mL) 6 9 12 13 6
3rd trimester: <50 copies/mL 5 8 10 13 5
Postpartum (2-5 weeks): <50 copies/mL 5 8 9 9 5
Postpartum (6-12 weeks): <50 copies/mL 6 7 8 10 5
8.Secondary Outcome
Title Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value
Hide Description Mean change from baseline in log 10 HIV-1 RNA VL was assessed up to postpartum (6-12 weeks).
Time Frame Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 600 mg /Ritonavir 100 Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 17 18 15 19 7
Mean (Standard Error)
Unit of Measure: Log 10 copies per milliliter (copies/mL)
Baseline Number Analyzed 17 participants 18 participants 15 participants 19 participants 6 participants
2.12  (0.179) 1.88  (0.089) 2.06  (0.206) 1.84  (0.159) 1.77  (0.283)
4 Weeks after Baseline Number Analyzed 4 participants 10 participants 4 participants 4 participants 0 participants
-0.26  (0.161) -0.27  (0.145) 0.18  (0.182) 0.20  (0.172)
2nd trimester Number Analyzed 16 participants 17 participants 13 participants 14 participants 7 participants
-0.19  (0.106) -0.16  (0.104) 0.16  (0.084) 0.16  (0.074) 0.1  (0.233)
3rd trimester Number Analyzed 13 participants 15 participants 11 participants 13 participants 6 participants
-0.31  (0.107) -0.23  (0.105) 0.17  (0.105) 0.25  (0.113) 0.21  (0.326)
Postpartum (2-5 weeks) Number Analyzed 12 participants 16 participants 11 participants 12 participants 6 participants
-0.18  (0.111) -0.04  (0.146) 0.13  (0.168) 0.20  (0.273) 0.18  (0.304)
Postpartum (6-12 weeks) Number Analyzed 13 participants 16 participants 10 participants 12 participants 6 participants
0.09  (0.268) 0.11  (0.265) 0.05  (0.058) 0.08  (0.138) 0.23  (0.347)
9.Secondary Outcome
Title Mean Change From Baseline in CD4+ Cell Count
Hide Description Mean Change From Baseline in CD4+ Cell Count were assessed for immunology testing.
Time Frame Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signified number of participants evaluated for this outcome measure.
Arm/Group Title Darunavir 600 mg /Ritonavir 100 Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
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Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 16 18 15 19 7
Mean (Standard Error)
Unit of Measure: 10^6 Cells/Liter
Baseline Number Analyzed 16 participants 18 participants 15 participants 19 participants 6 participants
466.3  (49.07) 497.9  (64.60) 417.47  (80.469) 495.79  (79.322) 594.17  (108.151)
4 Weeks after Baseline Number Analyzed 4 participants 10 participants 4 participants 4 participants 0 participants
-14.8  (23.16) 116.3  (62.41) 6.25  (26.004) 24.00  (56.912)
2nd trimester Number Analyzed 16 participants 17 participants 13 participants 14 participants 7 participants
37.1  (23.31) 154.1  (44.08) 13.77  (53.225) 39.21  (36.496) 13.29  (34.445)
3rd trimester Number Analyzed 13 participants 15 participants 10 participants 13 participants 6 participants
83.5  (29.45) 274.9  (65.41) 77.30  (30.803) 89.46  (26.137) 72.17  (62.882)
Postpartum (2-5 weeks) Number Analyzed 10 participants 16 participants 11 participants 12 participants 6 participants
127.9  (28.53) 186.0  (43.51) 115.36  (33.584) 139.42  (36.972) 163  (37.177)
Postpartum (6-12 weeks) Number Analyzed 13 participants 16 participants 10 participants 11 participants 6 participants
174.5  (44.98) 323.0  (63.99) 154.90  (54.131) 168.18  (41.345) 244.67  (100.74)
10.Secondary Outcome
Title Number of Participants With Resistance at Virological Failure
Hide Description Resistance analysis was determined using genotypic and phenotypic analysis at the time of virological failure. For participants with a baseline viral load greater than (>) 200 copies/mL, virologic failure was defined as follows: HIV ribonucleic acid (RNA) levels that did not fall by at least 0.5 log 4 weeks after Baseline; viral load >1000 copies/mL (at 2 successive visits) by gestational weeks 34-38; or viral load >200 copies/mL (at 2 successive visits) after reaching a viral load less than or equal to (<=) 200 copies/mL. For participants with a baseline viral load <=200 copies/mL, virologic failure was defined as viral load of >200 copies/mL (at 2 successive visits) at any point during the study.
Time Frame Up to follow-up phase (16 weeks after postpartum)
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Hide Analysis Population Description
Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.
Arm/Group Title Darunavir 600 mg /Ritonavir 100 Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 18 18 15 19 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0
11.Secondary Outcome
Title Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery
Hide Description The drug concentrations were evaluated in the cord plasma and maternal plasma samples collected at the time of delivery.
Time Frame On day of delivery - Intrapartum (Visit 6)
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Hide Analysis Population Description
Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.
Arm/Group Title Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 10 10 16 16 11 9 5 5
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Cord Plasma Number Analyzed 10 participants 7 participants 16 participants 16 participants 10 participants 8 participants 5 participants 5 participants
348.4  (322.90) 17.07  (23.98) 228  (302) NA [1]   (NA) 147  (61.3) 32.8  (16.7) 125  (106) NA [1]   (NA)
Maternal Plasma Number Analyzed 10 participants 10 participants 16 participants 16 participants 11 participants 9 participants 5 participants 5 participants
2149  (1140) 316.7  (394.4) 1663  (1691) 154  (274) 421  (157) 59.0  (34.7) 857  (885) 74.5  (109)
[1]
The data was not analyzed in case either the cord or maternal plasma concentration was below quantification limit (lesser than (<) 5.00 ng/mL).
12.Secondary Outcome
Title Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result
Hide Description The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).
Time Frame Birth to age 16 weeks
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Hide Analysis Population Description
Infants population whose mothers were included in Intent-to-treat (ITT) analysis set and who were enrolled in this study and took at least one dose of study medication. 'N' signifies number of infants who were born and had HIV test data available.
Arm/Group Title Darunavir 600 mg /Ritonavir 100 Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 14 17 11 10 6
Measure Type: Number
Unit of Measure: infants
0 0 0 0 0
13.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame Up to follow up period (16 weeks after postpartum)
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Hide Analysis Population Description
Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.
Arm/Group Title Darunavir 600 mg /Ritonavir 100 Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Hide Arm/Group Description:
Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum.
Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
Overall Number of Participants Analyzed 18 18 15 19 7
Measure Type: Number
Unit of Measure: Participants
Any AE 14 17 12 9 5
Any SAE 6 6 4 4 1
Time Frame Up to Follow up phase (16 weeks after postpartum)
Adverse Event Reporting Description Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.
 
Arm/Group Title Darunavir 600 mg /Ritonavir 100 mg Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Hide Arm/Group Description Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum. Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum. Participants received etravirine 200 mg (1*200 mg/2*100 mg) tablets orally twice daily up to 12 weeks postpartum. Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum. Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
All-Cause Mortality
Darunavir 600 mg /Ritonavir 100 mg Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Darunavir 600 mg /Ritonavir 100 mg Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/18 (33.33%)   6/18 (33.33%)   4/15 (26.67%)   4/19 (21.05%)   1/7 (14.29%) 
Ear and labyrinth disorders           
Vertigo * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Eye disorders           
Vision Blurred * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Gastrointestinal disorders           
Abdominal Pain * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Infections and infestations           
Postoperative Wound Infection * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Sepsis * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Investigations           
Medical Observation * 1  1/18 (5.56%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Transaminases Increased * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Blood Pressure Increased * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Metabolism and nutrition disorders           
Dehydration * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Gestational Diabetes * 1  0/18 (0.00%)  2/18 (11.11%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Nervous system disorders           
Headache * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Chorioamnionitis * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  2/19 (10.53%)  0/7 (0.00%) 
Intra-Uterine Death * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Oligohydramnios * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Pre-Eclampsia * 1  1/18 (5.56%)  1/18 (5.56%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Pregnancy Induced Hypertension * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Premature Labour * 1  1/18 (5.56%)  0/18 (0.00%)  1/15 (6.67%)  1/19 (5.26%)  0/7 (0.00%) 
Premature Rupture of Membranes * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders           
Proteinuria * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Vascular disorders           
Hypertension * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1 and 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Darunavir 600 mg /Ritonavir 100 mg Twice Daily Darunavir 800 mg /Ritonavir 100 mg Once Daily Etravirine 200 mg Twice Daily Rilpivirine 25 mg Once Daily Darunavir 800 mg/Cobicistat 150 mg Once Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/18 (72.22%)   17/18 (94.44%)   12/15 (80.00%)   8/19 (42.11%)   5/7 (71.43%) 
Blood and lymphatic system disorders           
Anaemia * 1  1/18 (5.56%)  3/18 (16.67%)  1/15 (6.67%)  1/19 (5.26%)  1/7 (14.29%) 
Anaemia of Pregnancy * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Iron Deficiency Anaemia * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Lymphadenopathy * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Thrombocytopenia * 1  0/18 (0.00%)  1/18 (5.56%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Eye disorders           
Vision Blurred * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Gastrointestinal disorders           
Constipation * 1  0/18 (0.00%)  2/18 (11.11%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Diarrhoea * 1  1/18 (5.56%)  2/18 (11.11%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Dyspepsia * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/18 (0.00%)  3/18 (16.67%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Nausea * 1  2/18 (11.11%)  3/18 (16.67%)  3/15 (20.00%)  0/19 (0.00%)  1/7 (14.29%) 
Toothache * 1  1/18 (5.56%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Vomiting * 1  0/18 (0.00%)  3/18 (16.67%)  2/15 (13.33%)  1/19 (5.26%)  0/7 (0.00%) 
Abdominal Pain * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Abdominal Pain Lower * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Abdominal Pain Upper * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Haemorrhoids * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
General disorders           
Influenza Like Illness * 1  2/18 (11.11%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Pitting Oedema * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Pyrexia * 1  2/18 (11.11%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Chest Pain * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Fatigue * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Oedema Peripheral * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Immune system disorders           
Seasonal Allergy * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Infections and infestations           
Bacteriuria * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Carbuncle * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Fungal Infection * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Genital Herpes * 1  1/18 (5.56%)  1/18 (5.56%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Herpes Zoster * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Nasopharyngitis * 1  1/18 (5.56%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Otitis Media * 1  0/18 (0.00%)  1/18 (5.56%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Pharyngitis * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Sinusitis * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Subcutaneous Abscess * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Tinea Pedis * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Upper Respiratory Tract Infection * 1  1/18 (5.56%)  0/18 (0.00%)  1/15 (6.67%)  1/19 (5.26%)  0/7 (0.00%) 
Urinary Tract Infection * 1  2/18 (11.11%)  2/18 (11.11%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Vaginal Infection * 1  0/18 (0.00%)  2/18 (11.11%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Vaginitis Bacterial * 1  2/18 (11.11%)  2/18 (11.11%)  1/15 (6.67%)  1/19 (5.26%)  0/7 (0.00%) 
Viral Upper Respiratory Tract Infection * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Vulvovaginal Mycotic Infection * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  2/7 (28.57%) 
Injury, poisoning and procedural complications           
Contusion * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Eye Injury * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Investigations           
Alanine Aminotransferase Increased * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Blood Albumin Increased * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Blood Amylase Increased * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Blood Pressure Increased * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  1/7 (14.29%) 
Blood Thyroid Stimulating Hormone Increased * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Cardiac Murmur * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Lipase Increased * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Methicillin-Resistant Staphylococcal Aureus Test Positive * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Neutrophil Count Decreased * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Streptococcal Identification Test Positive * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Transaminases Increased * 1  1/18 (5.56%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Heart Rate Increased * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
High Density Lipoprotein Increased * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Metabolism and nutrition disorders           
Anorexia * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Decreased Appetite * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Dehydration * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Gestational Diabetes * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Hyperlipidaemia * 1  2/18 (11.11%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Hypoalbuminaemia * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Hypokalaemia * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Back Pain * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  1/7 (14.29%) 
Pain in Extremity * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Joint Swelling * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Nervous system disorders           
Carpal Tunnel Syndrome * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Dizziness * 1  2/18 (11.11%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Headache * 1  1/18 (5.56%)  2/18 (11.11%)  2/15 (13.33%)  0/19 (0.00%)  1/7 (14.29%) 
Hypoaesthesia * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Migraine * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Migraine with Aura * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Poor Quality Sleep * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Pregnancy, puerperium and perinatal conditions           
Chorioamnionitis * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Labour Pain * 1  0/18 (0.00%)  2/18 (11.11%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Postpartum Haemorrhage * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Pregnancy Induced Hypertension * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  1/19 (5.26%)  0/7 (0.00%) 
Premature Labour * 1  4/18 (22.22%)  2/18 (11.11%)  2/15 (13.33%)  0/19 (0.00%)  0/7 (0.00%) 
Uterine Contractions During Pregnancy * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Psychiatric disorders           
Insomnia * 1  1/18 (5.56%)  1/18 (5.56%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Major Depression * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Postpartum Depression * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Depression * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Renal and urinary disorders           
Hydronephrosis * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Reproductive system and breast disorders           
Genital Discharge * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Ovarian Cyst * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  1/19 (5.26%)  0/7 (0.00%) 
Pelvic Pain * 1  0/18 (0.00%)  1/18 (5.56%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Vaginal Discharge * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  2/19 (10.53%)  0/7 (0.00%) 
Pelvic Discomfort * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Vaginal Haemorrhage * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Vulvovaginal Pruritus * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders           
Asthma * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Cough * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Dyspnoea * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
Nasal Congestion * 1  0/18 (0.00%)  1/18 (5.56%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Rhinitis Allergic * 1  0/18 (0.00%)  1/18 (5.56%)  2/15 (13.33%)  0/19 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis Atopic * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Dry Skin * 1  1/18 (5.56%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Rash * 1  0/18 (0.00%)  2/18 (11.11%)  0/15 (0.00%)  0/19 (0.00%)  0/7 (0.00%) 
Skin Exfoliation * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Vascular disorders           
Hypertension * 1  0/18 (0.00%)  0/18 (0.00%)  1/15 (6.67%)  0/19 (0.00%)  0/7 (0.00%) 
Hypotension * 1  0/18 (0.00%)  0/18 (0.00%)  0/15 (0.00%)  0/19 (0.00%)  1/7 (14.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1 and 16.0
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Medical Leader, Medical Department
Organization: Janssen Scientific Affairs, LLC
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00855335     History of Changes
Other Study ID Numbers: CR015442
TMC114HIV3015 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: March 2, 2009
First Posted: March 4, 2009
Results First Submitted: June 30, 2017
Results First Posted: September 15, 2017
Last Update Posted: July 6, 2018