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
Sponsor
Janssen Scientific Affairs, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00855335
Collaborator
(none)
77
17
5
88.1
4.5
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
There are many biological changes that occur during pregnancy, some of which may affect the way HIV medications are absorbed, distributed and removed within the body. Some medications have been used for HIV treatment during pregnancy, but little is known about how pregnancy affects the class of drugs being used in this study. To participate in this study, patients must be receiving 600mg of TMC114 (darunavir) taken with 100mg ritonavir twice daily or 800mg of TMC114 (darunavir) with 100mg of ritonavir once daily or 800 mg of darunavir taken with 150mg of cobicistat taken once daily or 200mg of TMC125 (etravirine) (with or without darunavir/ ritonavir) taken twice daily or 25mg of TMC278 (rilpivirine) taken once daily plus additional antiretroviral drugs needed to construct an active antiretroviral regimen. Darunavir and ritonavir, darunavir and cobicistat, etravirine, or rilpivirine will be supplied to study participants. Darunavir and ritonavir are human immunodeficiency virus (HIV) protease inhibitors (PIs); cobicistat is a pharmacoenhancer which boosts the levels of darunavir but has no anti-HIV activity; etravirine and rilpivirine are non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV. Twelve-hour or twenty four-hour blood sampling will be done for each patient at each of three study visits: Visit 4 (2nd trimester), Visit 5 (3rd trimester), and Visit 8 (6-12 weeks postpartum). Eight blood draws will be taken during each visit: One prior to intake of study medication, and one for each of seven post-dose sampling time-points (hours 1, 2, 3, 4, 6, 9 and 12). The study is designed primarily to examine the pharmacokinetics of darunavir/ritonavir (darunavir/r), darunavir/ cobicistat, etravirine or rilpivirine during the second and third trimesters of gestation, as well as postpartum. Pharmacokinetics measures how the body absorbs, distributes and excretes medication. The study will also examine any changes in anti-viral activity during pregnancy, and the postpartum period. It will note any safety and tolerability of the medications used by the mother, and will measure the level of darunavir/ritonavir, darunavir/ cobicistat, etravirine or rilpivirine in the newborn's cord blood at the time of delivery; outcomes for both mother and child will be assessed as well. During the treatment period, patients will be seen at regular visits in the clinic, where the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring. Up to forty-eight (48) HIV positive pregnant women will participate in this study. Study enrollment will be closed once 12 evaluable patients taking darunavir/ritonavir once daily, 12 evaluable patients taking darunavir/cobicistat once daily, 12 evaluable patients taking darunavir/ritonavir twice daily, 12 evaluable patients taking etravirine taking twice daily and 12 evaluable patients taking rilpivirine once daily have been enrolled. The study will be conducted at approximately 14 research centers in the United States and 1 in Puerto Rico. In order to participate, patients must be pregnant for 13-24 weeks. The primary purpose (or outcome) of the study is to assess the influence of pregnancy on the pharmacokinetics of darunavir/ritonavir, darunavir/ cobicistat, etravirine or rilpivirine during the second and third trimesters of gestation, as well as postpartum. Darunavir: One 600 mg or two 300 mg tablets taken twice daily by mouth (two or four tablets a day total). Ritonavir: 100mg tablet taken twice daily by mouth (two tablets a day total), together with darunavir. Darunavir: Two 400 mg tablets taken once daily by mouth (two tablets a day total). Ritonavir: 100mg tablet taken once daily by mouth (one tablet a day total), together with darunavir. Darunavir/ cobicistat: a fixed dose combination containing 800mg of darunavir and 150mg of cobicistat. Etravirine: Two 100 mg tablets taken twice daily by mouth (four tablets a day total). Rilpivirine: One 25mg tablet taken once daily by mouth (one tablet a day total). Study medication will be given from the baseline visit (second pregnancy trimester) until Visit 8 (up to 12 weeks after delivery).
Study Design
Study Type:
Interventional
Actual Enrollment
:
77 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date
:
Apr 9, 2009
Actual Primary Completion Date
:
Aug 11, 2016
Actual Study Completion Date
:
Aug 11, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: Darunavir 600 /Ritonavir 100 TMC114 (darunavir) Two 300 milligram (mg) or one 600 mg tablet twice daily up to 12 weeks postpartum / ritonavir one 100 mg tablet twice daily with darunavir up to 12 weeks postpartum. |
Drug: Darunavir
TMC114 (darunavir) two 300 mg or one 600 mg tablet twice daily up to 12 weeks postpartum in Group 1. TMC114 (darunavir) 800mg tablet once daily up to 12 weeks postpartum in Group 2.
Drug: Ritonavir
100 mg tablet twice daily up to 12 weeks postpartum.
|
| Experimental: Group 2: Darunavir 800/Ritonavir 100 TMC114 (darunavir) 800mg tablet once daily up to 12 weeks postpartum/ ritonavir one 100 mg tablet once daily with darunavir up to 12 weeks postpartum. |
Drug: Darunavir
TMC114 (darunavir) two 300 mg or one 600 mg tablet twice daily up to 12 weeks postpartum in Group 1. TMC114 (darunavir) 800mg tablet once daily up to 12 weeks postpartum in Group 2.
Drug: Ritonavir
100 mg tablet twice daily up to 12 weeks postpartum.
|
| Experimental: Group 3: Etravirine TMC125 (etravirine) 200 mg (1*200 mg/2*100 mg) tablets twice daily up to 12 weeks postpartum. |
Drug: Etravirine
200 mg (1*200 mg/2*100 mg) tablets twice daily up to 12 weeks postpartum.
|
| Experimental: Group 4: Rilpivirine TMC278 (rilpivirine) One 25 mg tablet once daily up to 12 weeks postpartum. |
Drug: Rilpivirine
One 25 mg tablet once daily up to 12 weeks postpartum.
|
| Experimental: Group 5: Darunavir 800/Cobicistat 150 Fixed dose combination (FDC) tablet of TMC114 (darunavir) 800 mg and cobicistat 150 mg once daily up to 12 weeks postpartum. |
Drug: Darunavir/Cobicistat (FDC)
Fixed dose combination (FDC) tablet of TMC114 (darunavir) 800 mg and cobicistat 150 mg once daily up to 12 weeks postpartum.
|
Outcome Measures
Primary Outcome Measures
- Predose (Trough) Plasma Concentration (C0h) [Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)]
C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.
- Minimum Plasma Concentration (Cmin) [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)]
The Cmin is the minimum observed plasma concentration.
- Maximum Plasma Concentration (Cmax) [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)]
The Cmax is the maximum observed plasma concentration.
- Time to Reach the Maximum Plasma Concentration (Tmax) [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)]
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
- Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) [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)]
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).
- Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) [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)]
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).
Secondary Outcome Measures
- Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) [Up to postpartum (6-12 weeks)]
Number of participants were assessed with a viral load (VL) lesser than (<) 50 HIV-1 RNA copies/ mL over time.
- Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value [Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)]
Mean change from baseline in log 10 HIV-1 RNA VL was assessed up to postpartum (6-12 weeks).
- Mean Change From Baseline in CD4+ Cell Count [Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)]
Mean Change From Baseline in CD4+ Cell Count were assessed for immunology testing.
- Number of Participants With Resistance at Virological Failure [Up to follow-up phase (16 weeks after postpartum)]
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.
- Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery [On day of delivery - Intrapartum (Visit 6)]
The drug concentrations were evaluated in the cord plasma and maternal plasma samples collected at the time of delivery.
- Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result [Birth to age 16 weeks]
The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to follow up period (16 weeks after postpartum)]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Pregnant females (18-26 weeks of gestation)
-
documented HIV-1 infection
-
Receiving darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine at the time of study entry
-
Willing to remain on darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine as well as a background regimen, for the duration of the study, including 12 weeks postpartum
-
Able to comply with the protocol requirements and to provide written informed consent.
Exclusion Criteria:
-
Patients with any currently active acquired immune deficiency syndrome (AIDS) defining illness and AIDS-related opportunistic infection
-
Patients using cytokine inhibitors (e.g., thalidomide), anabolic hormones, cytokines (e.g., IL-2, INF), efavirenz, hydroxyurea, oral hypoglycemics, systemic chemotherapy or known teratogenic agent
-
Use of an investigational agent within 90 days
-
Any known fetal anomaly
-
Any current obstetric complication, including multiple gestations and pre-term labor
-
Hepatitis B and/or C virus infection
-
Grade 2 or higher anemia
-
Thyroid disease
-
Uncontrolled Diabetes Mellitus Types I and II, or gestational diabetes, as determined by the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Daytona Beach | Florida | United States | ||
| 2 | Jacksonville | Florida | United States | ||
| 3 | Miami | Florida | United States | ||
| 4 | Pensacola | Florida | United States | ||
| 5 | Port Saint Lucie | Florida | United States | ||
| 6 | West Palm Beach | Florida | United States | ||
| 7 | Savannah | Georgia | United States | ||
| 8 | Chicago | Illinois | United States | ||
| 9 | Springfield | Massachusetts | United States | ||
| 10 | Dearborn | Michigan | United States | ||
| 11 | Bronx | New York | United States | ||
| 12 | Syracuse | New York | United States | ||
| 13 | Chapel Hill | North Carolina | United States | ||
| 14 | Greensboro | North Carolina | United States | ||
| 15 | Philadelphia | Pennsylvania | United States | ||
| 16 | Bellaire | Texas | United States | ||
| 17 | San Juan Pr | Puerto Rico |
Sponsors and Collaborators
- Janssen Scientific Affairs, LLC
Investigators
- Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00855335
Other Study ID Numbers:
- CR015442
- TMC114HIV3015
First Posted:
Mar 4, 2009
Last Update Posted:
Jul 6, 2018
Last Verified:
May 1, 2018
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Scientific Affairs, LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| 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 |
|---|---|---|---|---|---|
| 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 |
Baseline Characteristics
| 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 |
|---|---|---|---|---|---|---|
| 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 Participants | 18 | 18 | 15 | 19 | 7 | 77 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
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 (Count of Participants) | ||||||
| Female |
18
100%
|
18
100%
|
15
100%
|
19
100%
|
7
100%
|
77
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||||
| United States |
18
100%
|
18
100%
|
15
100%
|
19
100%
|
7
100%
|
77
100%
|
Outcome Measures
| Title | Predose (Trough) Plasma Concentration (C0h) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 12 | 13 | 17 | 17 | 13 | 15 | 7 | 7 |
| Postpartum (6-12 W) |
3608
(2812)
|
491.4
(472.4)
|
2481
(2183)
|
147
(198)
|
281
(193)
|
127
(97.0)
|
2811
(2296)
|
134
(145)
|
| 2nd Trimester |
2323
(1140)
|
225.9
(127.5)
|
1793
(964)
|
94.2
(102)
|
439
(212)
|
75.6
(36.2)
|
540
(803)
|
NA
(NA)
|
| 3rd Trimester |
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)
|
| Title | Minimum Plasma Concentration (Cmin) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 12 | 13 | 17 | 17 | 13 | 15 | 7 | 7 |
| Postpartum (6-12 W) |
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 |
1922
(825)
|
141.1
(73.78)
|
1248
(542)
|
32.2
(19.8)
|
383
(210)
|
54.3
(25.8)
|
168
(149)
|
NA
(NA)
|
| 3rd Trimester |
2661
(1269)
|
148.1
(52.26)
|
1075
(594)
|
28.0
(20.5)
|
349
(103)
|
52.9
(24.4)
|
184
(99.0)
|
NA
(NA)
|
| Title | Maximum Plasma Concentration (Cmax) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 12 | 13 | 17 | 17 | 13 | 15 | 7 | 7 |
| Postpartum (6-12 W) |
6659
(2364)
|
1110
(901.2)
|
7310
(1704)
|
742
(335)
|
569
(261)
|
167
(101)
|
7918
(2199)
|
996
(323)
|
| 2nd Trimester |
4668
(1097)
|
546.8
(249.4)
|
4964
(1505)
|
439
(241)
|
774
(300)
|
121
(45.9)
|
4340
(1616)
|
571
(350)
|
| 3rd Trimester |
5328
(1631)
|
536.1
(210.6)
|
5132
(1198)
|
397
(184)
|
785
(238)
|
123
(47.5)
|
4910
(970)
|
759
(366)
|
| Title | Time to Reach the Maximum Plasma Concentration (Tmax) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 12 | 13 | 17 | 17 | 13 | 15 | 7 | 7 |
| Postpartum (6-12 W) |
3.00
|
5.04
|
4.00
|
4.18
|
4.00
|
4.00
|
4.00
|
4.00
|
| 2nd Trimester |
3.00
|
4.17
|
4.00
|
5.92
|
3.05
|
4.00
|
4.00
|
4.03
|
| 3rd Trimester |
3.00
|
4.07
|
3.05
|
6.00
|
3.00
|
4.00
|
3.50
|
3.50
|
| Title | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|
| 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. |
| Measure Participants | 12 | 12 | 13 |
| Postpartum (6-12 W) |
56890
(26340)
|
7406
(6188)
|
5004
(2521)
|
| 2nd Trimester |
39370
(9597)
|
3775
(1265)
|
6617
(2766)
|
| 3rd Trimester |
45880
(17360)
|
3750
(1336)
|
6846
(1482)
|
| Title | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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. |
| Measure Participants | 17 | 17 | 15 | 7 | 7 |
| Postpartum (6-12 W) |
92116
(29241)
|
6584
(2861)
|
2714
(1535)
|
99613
(34862)
|
8643
(3187)
|
| 2nd trimester |
62289
(16234)
|
3935
(2063)
|
1792
(711)
|
47293
(19058)
|
3862
(2703)
|
| 3rd trimester |
61112
(13790)
|
3821
(1723)
|
1762
(662)
|
47991
(9879)
|
4736
(2917)
|
| Title | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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. |
| Measure Participants | 16 | 17 | 13 | 19 | 6 |
| 2nd trimester Less than(<)50 copies/milliLiter(mL) |
6
33.3%
|
9
50%
|
12
80%
|
13
68.4%
|
6
85.7%
|
| 3rd trimester: <50 copies/mL |
5
27.8%
|
8
44.4%
|
10
66.7%
|
13
68.4%
|
5
71.4%
|
| Postpartum (2-5 weeks): <50 copies/mL |
5
27.8%
|
8
44.4%
|
9
60%
|
9
47.4%
|
5
71.4%
|
| Postpartum (6-12 weeks): <50 copies/mL |
6
33.3%
|
7
38.9%
|
8
53.3%
|
10
52.6%
|
5
71.4%
|
| Title | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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. |
| Measure Participants | 17 | 18 | 15 | 19 | 7 |
| Baseline |
2.12
(0.179)
|
1.88
(0.089)
|
2.06
(0.206)
|
1.84
(0.159)
|
1.77
(0.283)
|
| 4 Weeks after Baseline |
-0.26
(0.161)
|
-0.27
(0.145)
|
0.18
(0.182)
|
0.20
(0.172)
|
|
| 2nd trimester |
-0.19
(0.106)
|
-0.16
(0.104)
|
0.16
(0.084)
|
0.16
(0.074)
|
0.1
(0.233)
|
| 3rd trimester |
-0.31
(0.107)
|
-0.23
(0.105)
|
0.17
(0.105)
|
0.25
(0.113)
|
0.21
(0.326)
|
| Postpartum (2-5 weeks) |
-0.18
(0.111)
|
-0.04
(0.146)
|
0.13
(0.168)
|
0.20
(0.273)
|
0.18
(0.304)
|
| Postpartum (6-12 weeks) |
0.09
(0.268)
|
0.11
(0.265)
|
0.05
(0.058)
|
0.08
(0.138)
|
0.23
(0.347)
|
| Title | Mean Change From Baseline in CD4+ Cell Count |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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. |
| Measure Participants | 16 | 18 | 15 | 19 | 7 |
| Baseline |
466.3
(49.07)
|
497.9
(64.60)
|
417.47
(80.469)
|
495.79
(79.322)
|
594.17
(108.151)
|
| 4 Weeks after Baseline |
-14.8
(23.16)
|
116.3
(62.41)
|
6.25
(26.004)
|
24.00
(56.912)
|
|
| 2nd trimester |
37.1
(23.31)
|
154.1
(44.08)
|
13.77
(53.225)
|
39.21
(36.496)
|
13.29
(34.445)
|
| 3rd trimester |
83.5
(29.45)
|
274.9
(65.41)
|
77.30
(30.803)
|
89.46
(26.137)
|
72.17
(62.882)
|
| Postpartum (2-5 weeks) |
127.9
(28.53)
|
186.0
(43.51)
|
115.36
(33.584)
|
139.42
(36.972)
|
163
(37.177)
|
| Postpartum (6-12 weeks) |
174.5
(44.98)
|
323.0
(63.99)
|
154.90
(54.131)
|
168.18
(41.345)
|
244.67
(100.74)
|
| Title | Number of Participants With Resistance at Virological Failure |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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. |
| Measure Participants | 18 | 18 | 15 | 19 | 7 |
| Number [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 10 | 10 | 16 | 16 | 11 | 9 | 5 | 5 |
| Cord Plasma |
348.4
(322.90)
|
17.07
(23.98)
|
228
(302)
|
NA
(NA)
|
147
(61.3)
|
32.8
(16.7)
|
125
(106)
|
NA
(NA)
|
| Maternal Plasma |
2149
(1140)
|
316.7
(394.4)
|
1663
(1691)
|
154
(274)
|
421
(157)
|
59.0
(34.7)
|
857
(885)
|
74.5
(109)
|
| Title | Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result |
|---|---|
| Description | The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR). |
| Time Frame | Birth to age 16 weeks |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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. |
| Measure Participants | 14 | 17 | 11 | 10 | 6 |
| Number [infants] |
0
|
0
|
0
|
0
|
0
|
| Title | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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. |
| Measure Participants | 18 | 18 | 15 | 19 | 7 |
| Any AE |
14
77.8%
|
17
94.4%
|
12
80%
|
9
47.4%
|
5
71.4%
|
| Any SAE |
6
33.3%
|
6
33.3%
|
4
26.7%
|
4
21.1%
|
1
14.3%
|
Adverse Events
| 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 | |||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/18 (33.3%) | 6/18 (33.3%) | 4/15 (26.7%) | 4/19 (21.1%) | 1/7 (14.3%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Vertigo | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Eye disorders | ||||||||||
| Vision Blurred | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal Pain | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Infections and infestations | ||||||||||
| Postoperative Wound Infection | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Sepsis | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Investigations | ||||||||||
| Medical Observation | 1/18 (5.6%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Transaminases Increased | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Blood Pressure Increased | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Gestational Diabetes | 0/18 (0%) | 2/18 (11.1%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||
| Chorioamnionitis | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 2/19 (10.5%) | 0/7 (0%) | |||||
| Intra-Uterine Death | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Oligohydramnios | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Pre-Eclampsia | 1/18 (5.6%) | 1/18 (5.6%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Pregnancy Induced Hypertension | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Premature Labour | 1/18 (5.6%) | 0/18 (0%) | 1/15 (6.7%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Premature Rupture of Membranes | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Proteinuria | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
Other (Not Including 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/18 (72.2%) | 17/18 (94.4%) | 12/15 (80%) | 8/19 (42.1%) | 5/7 (71.4%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 1/18 (5.6%) | 3/18 (16.7%) | 1/15 (6.7%) | 1/19 (5.3%) | 1/7 (14.3%) | |||||
| Anaemia of Pregnancy | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Iron Deficiency Anaemia | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Lymphadenopathy | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Thrombocytopenia | 0/18 (0%) | 1/18 (5.6%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Eye disorders | ||||||||||
| Vision Blurred | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Gastrointestinal disorders | ||||||||||
| Constipation | 0/18 (0%) | 2/18 (11.1%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Diarrhoea | 1/18 (5.6%) | 2/18 (11.1%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Dyspepsia | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Gastrooesophageal Reflux Disease | 0/18 (0%) | 3/18 (16.7%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Nausea | 2/18 (11.1%) | 3/18 (16.7%) | 3/15 (20%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Toothache | 1/18 (5.6%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Vomiting | 0/18 (0%) | 3/18 (16.7%) | 2/15 (13.3%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Abdominal Pain | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Abdominal Pain Lower | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Abdominal Pain Upper | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Haemorrhoids | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| General disorders | ||||||||||
| Influenza Like Illness | 2/18 (11.1%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Pitting Oedema | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Pyrexia | 2/18 (11.1%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Chest Pain | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Fatigue | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Oedema Peripheral | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Immune system disorders | ||||||||||
| Seasonal Allergy | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Infections and infestations | ||||||||||
| Bacteriuria | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Carbuncle | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Fungal Infection | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Genital Herpes | 1/18 (5.6%) | 1/18 (5.6%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Herpes Zoster | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Nasopharyngitis | 1/18 (5.6%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Otitis Media | 0/18 (0%) | 1/18 (5.6%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Pharyngitis | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Sinusitis | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Subcutaneous Abscess | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Tinea Pedis | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Upper Respiratory Tract Infection | 1/18 (5.6%) | 0/18 (0%) | 1/15 (6.7%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Urinary Tract Infection | 2/18 (11.1%) | 2/18 (11.1%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Vaginal Infection | 0/18 (0%) | 2/18 (11.1%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Vaginitis Bacterial | 2/18 (11.1%) | 2/18 (11.1%) | 1/15 (6.7%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Viral Upper Respiratory Tract Infection | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Vulvovaginal Mycotic Infection | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 2/7 (28.6%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Contusion | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Eye Injury | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Investigations | ||||||||||
| Alanine Aminotransferase Increased | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Blood Albumin Increased | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Blood Amylase Increased | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Blood Pressure Increased | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Blood Thyroid Stimulating Hormone Increased | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Cardiac Murmur | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Lipase Increased | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Methicillin-Resistant Staphylococcal Aureus Test Positive | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Neutrophil Count Decreased | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Streptococcal Identification Test Positive | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Transaminases Increased | 1/18 (5.6%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Heart Rate Increased | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| High Density Lipoprotein Increased | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Anorexia | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Decreased Appetite | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Dehydration | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Gestational Diabetes | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Hyperlipidaemia | 2/18 (11.1%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Hypoalbuminaemia | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Hypokalaemia | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Back Pain | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Pain in Extremity | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Joint Swelling | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Nervous system disorders | ||||||||||
| Carpal Tunnel Syndrome | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Dizziness | 2/18 (11.1%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Headache | 1/18 (5.6%) | 2/18 (11.1%) | 2/15 (13.3%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Hypoaesthesia | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Migraine | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Migraine with Aura | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Poor Quality Sleep | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||
| Chorioamnionitis | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Labour Pain | 0/18 (0%) | 2/18 (11.1%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Postpartum Haemorrhage | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Pregnancy Induced Hypertension | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Premature Labour | 4/18 (22.2%) | 2/18 (11.1%) | 2/15 (13.3%) | 0/19 (0%) | 0/7 (0%) | |||||
| Uterine Contractions During Pregnancy | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 1/18 (5.6%) | 1/18 (5.6%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Major Depression | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Postpartum Depression | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Depression | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Renal and urinary disorders | ||||||||||
| Hydronephrosis | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Genital Discharge | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Ovarian Cyst | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 1/19 (5.3%) | 0/7 (0%) | |||||
| Pelvic Pain | 0/18 (0%) | 1/18 (5.6%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Vaginal Discharge | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 2/19 (10.5%) | 0/7 (0%) | |||||
| Pelvic Discomfort | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Vaginal Haemorrhage | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Vulvovaginal Pruritus | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Asthma | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Cough | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Dyspnoea | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
| Nasal Congestion | 0/18 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Rhinitis Allergic | 0/18 (0%) | 1/18 (5.6%) | 2/15 (13.3%) | 0/19 (0%) | 0/7 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Dermatitis Atopic | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Dry Skin | 1/18 (5.6%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Rash | 0/18 (0%) | 2/18 (11.1%) | 0/15 (0%) | 0/19 (0%) | 0/7 (0%) | |||||
| Skin Exfoliation | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 0/18 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/19 (0%) | 0/7 (0%) | |||||
| Hypotension | 0/18 (0%) | 0/18 (0%) | 0/15 (0%) | 0/19 (0%) | 1/7 (14.3%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| Phone | |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00855335
Other Study ID Numbers:
- CR015442
- TMC114HIV3015
First Posted:
Mar 4, 2009
Last Update Posted:
Jul 6, 2018
Last Verified:
May 1, 2018