HIV, HIV Infections, Pregnancy
Conditions
Keywords
HIV-1, HIV, Pregnancy, Postpartum, Human immunodeficiency virus, PREZISTA, INTELENCE, NORVIR, TMC114, TMC125, darunavir, ritonavir, etravirine, rilpivirine, TMC278, Cobicistat, treatment experienced
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.
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).
Interventions
DRUGDarunavir
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.
DRUGRitonavir
100 mg tablet twice daily up to 12 weeks postpartum.
DRUGEtravirine
200 mg (1\*200 mg/2\*100 mg) tablets twice daily up to 12 weeks postpartum.
DRUGRilpivirine
One 25 mg tablet once daily up to 12 weeks postpartum.
Fixed dose combination (FDC) tablet of TMC114 (darunavir) 800 mg and cobicistat 150 mg once daily up to 12 weeks postpartum.
Sponsors
Janssen Scientific Affairs, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Darunavir 600 mg /Ritonavir 100 mg Twice Daily Participants received darunavir 600 milligram (mg) tablets (300\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum. | 18 |
| Darunavir 800 mg /Ritonavir 100 mg Once Daily Participants received darunavir 800 mg tablets (400\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum. | 18 |
| Etravirine 200 mg Twice Daily Participants received etravirine 200 mg (1\*200 mg/2\*100 mg) tablets orally twice daily up to 12 weeks postpartum. | 15 |
| Rilpivirine 25 mg Once Daily Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum. | 19 |
| Darunavir 800 mg/Cobicistat 150 mg Once Daily 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. | 7 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 3 | 1 | 0 |
| Overall Study | Other | 2 | 1 | 2 | 5 | 1 |
| Overall Study | Physician Decision | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|
| Age, Continuous | 25.7 years STANDARD_DEVIATION 5.6 | 24.2 years STANDARD_DEVIATION 3.45 | 26.3 years STANDARD_DEVIATION 4.91 | 27.2 years STANDARD_DEVIATION 4.51 | 28.86 years STANDARD_DEVIATION 4.71 | 26.1 years STANDARD_DEVIATION 4.75 |
| Region of Enrollment United States | 18 Participants | 18 Participants | 15 Participants | 19 Participants | 7 Participants | 77 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 15 Participants | 19 Participants | 7 Participants | 77 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 18 | 17 / 18 | 12 / 15 | 8 / 19 | 5 / 7 |
| serious Total, serious adverse events | 6 / 18 | 6 / 18 | 4 / 15 | 4 / 19 | 1 / 7 |
Outcome results
Primary
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h)
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | Postpartum (6-12 W) | 56890 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 26340 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | 2nd Trimester | 39370 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 9597 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | 3rd Trimester | 45880 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 17360 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | 2nd Trimester | 3775 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 1265 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | 3rd Trimester | 3750 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 1336 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | Postpartum (6-12 W) | 7406 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 6188 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | Postpartum (6-12 W) | 5004 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 2521 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | 3rd Trimester | 6846 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 1482 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h) | 2nd Trimester | 6617 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 2766 |
Primary
Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h)
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | Postpartum (6-12 W) | 92116 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 29241 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 3rd trimester | 61112 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 13790 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 2nd trimester | 62289 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 16234 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 2nd trimester | 3935 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 2063 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | Postpartum (6-12 W) | 6584 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 2861 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 3rd trimester | 3821 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 1723 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 2nd trimester | 1792 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 711 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | Postpartum (6-12 W) | 2714 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 1535 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 3rd trimester | 1762 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 662 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | Postpartum (6-12 W) | 99613 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 34862 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 3rd trimester | 47991 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 9879 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 2nd trimester | 47293 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 19058 |
| Etravirine 200 mg Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 2nd trimester | 3862 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 2703 |
| Etravirine 200 mg Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | Postpartum (6-12 W) | 8643 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 3187 |
| Etravirine 200 mg Twice Daily | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) | 3rd trimester | 4736 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 2917 |
Primary
Maximum Plasma Concentration (Cmax)
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Maximum Plasma Concentration (Cmax) | Postpartum (6-12 W) | 6659 nanogram per milliliter (ng/mL) | Standard Deviation 2364 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Maximum Plasma Concentration (Cmax) | 3rd Trimester | 5328 nanogram per milliliter (ng/mL) | Standard Deviation 1631 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Maximum Plasma Concentration (Cmax) | 2nd Trimester | 4668 nanogram per milliliter (ng/mL) | Standard Deviation 1097 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Maximum Plasma Concentration (Cmax) | 3rd Trimester | 536.1 nanogram per milliliter (ng/mL) | Standard Deviation 210.6 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Maximum Plasma Concentration (Cmax) | 2nd Trimester | 546.8 nanogram per milliliter (ng/mL) | Standard Deviation 249.4 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Maximum Plasma Concentration (Cmax) | Postpartum (6-12 W) | 1110 nanogram per milliliter (ng/mL) | Standard Deviation 901.2 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Maximum Plasma Concentration (Cmax) | 3rd Trimester | 5132 nanogram per milliliter (ng/mL) | Standard Deviation 1198 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Maximum Plasma Concentration (Cmax) | Postpartum (6-12 W) | 7310 nanogram per milliliter (ng/mL) | Standard Deviation 1704 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Maximum Plasma Concentration (Cmax) | 2nd Trimester | 4964 nanogram per milliliter (ng/mL) | Standard Deviation 1505 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Maximum Plasma Concentration (Cmax) | Postpartum (6-12 W) | 742 nanogram per milliliter (ng/mL) | Standard Deviation 335 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Maximum Plasma Concentration (Cmax) | 2nd Trimester | 439 nanogram per milliliter (ng/mL) | Standard Deviation 241 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Maximum Plasma Concentration (Cmax) | 3rd Trimester | 397 nanogram per milliliter (ng/mL) | Standard Deviation 184 |
| Etravirine 200 mg Twice Daily | Maximum Plasma Concentration (Cmax) | 2nd Trimester | 774 nanogram per milliliter (ng/mL) | Standard Deviation 300 |
| Etravirine 200 mg Twice Daily | Maximum Plasma Concentration (Cmax) | Postpartum (6-12 W) | 569 nanogram per milliliter (ng/mL) | Standard Deviation 261 |
| Etravirine 200 mg Twice Daily | Maximum Plasma Concentration (Cmax) | 3rd Trimester | 785 nanogram per milliliter (ng/mL) | Standard Deviation 238 |
| Rilpivirine 25 mg Once Daily | Maximum Plasma Concentration (Cmax) | 2nd Trimester | 121 nanogram per milliliter (ng/mL) | Standard Deviation 45.9 |
| Rilpivirine 25 mg Once Daily | Maximum Plasma Concentration (Cmax) | Postpartum (6-12 W) | 167 nanogram per milliliter (ng/mL) | Standard Deviation 101 |
| Rilpivirine 25 mg Once Daily | Maximum Plasma Concentration (Cmax) | 3rd Trimester | 123 nanogram per milliliter (ng/mL) | Standard Deviation 47.5 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Maximum Plasma Concentration (Cmax) | 2nd Trimester | 4340 nanogram per milliliter (ng/mL) | Standard Deviation 1616 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Maximum Plasma Concentration (Cmax) | Postpartum (6-12 W) | 7918 nanogram per milliliter (ng/mL) | Standard Deviation 2199 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Maximum Plasma Concentration (Cmax) | 3rd Trimester | 4910 nanogram per milliliter (ng/mL) | Standard Deviation 970 |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Maximum Plasma Concentration (Cmax) | Postpartum (6-12 W) | 996 nanogram per milliliter (ng/mL) | Standard Deviation 323 |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Maximum Plasma Concentration (Cmax) | 2nd Trimester | 571 nanogram per milliliter (ng/mL) | Standard Deviation 350 |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Maximum Plasma Concentration (Cmax) | 3rd Trimester | 759 nanogram per milliliter (ng/mL) | Standard Deviation 366 |
Primary
Minimum Plasma Concentration (Cmin)
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Minimum Plasma Concentration (Cmin) | Postpartum (6-12 W) | 2851 nanogram per milliliter (ng/mL) | Standard Deviation 2216 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Minimum Plasma Concentration (Cmin) | 3rd Trimester | 2661 nanogram per milliliter (ng/mL) | Standard Deviation 1269 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Minimum Plasma Concentration (Cmin) | 2nd Trimester | 1922 nanogram per milliliter (ng/mL) | Standard Deviation 825 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Minimum Plasma Concentration (Cmin) | 3rd Trimester | 148.1 nanogram per milliliter (ng/mL) | Standard Deviation 52.26 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Minimum Plasma Concentration (Cmin) | 2nd Trimester | 141.1 nanogram per milliliter (ng/mL) | Standard Deviation 73.78 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Minimum Plasma Concentration (Cmin) | Postpartum (6-12 W) | 264.7 nanogram per milliliter (ng/mL) | Standard Deviation 259.8 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Minimum Plasma Concentration (Cmin) | 3rd Trimester | 1075 nanogram per milliliter (ng/mL) | Standard Deviation 594 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Minimum Plasma Concentration (Cmin) | Postpartum (6-12 W) | 1473 nanogram per milliliter (ng/mL) | Standard Deviation 1141 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Minimum Plasma Concentration (Cmin) | 2nd Trimester | 1248 nanogram per milliliter (ng/mL) | Standard Deviation 542 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Minimum Plasma Concentration (Cmin) | Postpartum (6-12 W) | 40.5 nanogram per milliliter (ng/mL) | Standard Deviation 31.4 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Minimum Plasma Concentration (Cmin) | 2nd Trimester | 32.2 nanogram per milliliter (ng/mL) | Standard Deviation 19.8 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Minimum Plasma Concentration (Cmin) | 3rd Trimester | 28.0 nanogram per milliliter (ng/mL) | Standard Deviation 20.5 |
| Etravirine 200 mg Twice Daily | Minimum Plasma Concentration (Cmin) | 2nd Trimester | 383 nanogram per milliliter (ng/mL) | Standard Deviation 210 |
| Etravirine 200 mg Twice Daily | Minimum Plasma Concentration (Cmin) | Postpartum (6-12 W) | 269 nanogram per milliliter (ng/mL) | Standard Deviation 182 |
| Etravirine 200 mg Twice Daily | Minimum Plasma Concentration (Cmin) | 3rd Trimester | 349 nanogram per milliliter (ng/mL) | Standard Deviation 103 |
| Rilpivirine 25 mg Once Daily | Minimum Plasma Concentration (Cmin) | 2nd Trimester | 54.3 nanogram per milliliter (ng/mL) | Standard Deviation 25.8 |
| Rilpivirine 25 mg Once Daily | Minimum Plasma Concentration (Cmin) | Postpartum (6-12 W) | 84.0 nanogram per milliliter (ng/mL) | Standard Deviation 58.8 |
| Rilpivirine 25 mg Once Daily | Minimum Plasma Concentration (Cmin) | 3rd Trimester | 52.9 nanogram per milliliter (ng/mL) | Standard Deviation 24.4 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Minimum Plasma Concentration (Cmin) | 2nd Trimester | 168 nanogram per milliliter (ng/mL) | Standard Deviation 149 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Minimum Plasma Concentration (Cmin) | Postpartum (6-12 W) | 1538 nanogram per milliliter (ng/mL) | Standard Deviation 1344 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Minimum Plasma Concentration (Cmin) | 3rd Trimester | 184 nanogram per milliliter (ng/mL) | Standard Deviation 99 |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Minimum Plasma Concentration (Cmin) | Postpartum (6-12 W) | 41.4 nanogram per milliliter (ng/mL) | Standard Deviation 49.1 |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Minimum Plasma Concentration (Cmin) | 2nd Trimester | NA nanogram per milliliter (ng/mL) | — |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Minimum Plasma Concentration (Cmin) | 3rd Trimester | NA nanogram per milliliter (ng/mL) | — |
Primary
Predose (Trough) Plasma Concentration (C0h)
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Predose (Trough) Plasma Concentration (C0h) | 3rd Trimester | 3280 nanogram per milliliter (ng/mL) | Standard Deviation 1466 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Predose (Trough) Plasma Concentration (C0h) | Postpartum (6-12 W) | 3608 nanogram per milliliter (ng/mL) | Standard Deviation 2812 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Predose (Trough) Plasma Concentration (C0h) | 2nd Trimester | 2323 nanogram per milliliter (ng/mL) | Standard Deviation 1140 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Predose (Trough) Plasma Concentration (C0h) | 3rd Trimester | 236.0 nanogram per milliliter (ng/mL) | Standard Deviation 108.08 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Predose (Trough) Plasma Concentration (C0h) | Postpartum (6-12 W) | 491.4 nanogram per milliliter (ng/mL) | Standard Deviation 472.4 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Predose (Trough) Plasma Concentration (C0h) | 2nd Trimester | 225.9 nanogram per milliliter (ng/mL) | Standard Deviation 127.5 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | Postpartum (6-12 W) | 2481 nanogram per milliliter (ng/mL) | Standard Deviation 2183 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | 2nd Trimester | 1793 nanogram per milliliter (ng/mL) | Standard Deviation 964 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | 3rd Trimester | 1528 nanogram per milliliter (ng/mL) | Standard Deviation 1184 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | Postpartum (6-12 W) | 147 nanogram per milliliter (ng/mL) | Standard Deviation 198 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | 3rd Trimester | 74.6 nanogram per milliliter (ng/mL) | Standard Deviation 90.2 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | 2nd Trimester | 94.2 nanogram per milliliter (ng/mL) | Standard Deviation 102 |
| Etravirine 200 mg Twice Daily | Predose (Trough) Plasma Concentration (C0h) | 3rd Trimester | 413 nanogram per milliliter (ng/mL) | Standard Deviation 78.2 |
| Etravirine 200 mg Twice Daily | Predose (Trough) Plasma Concentration (C0h) | 2nd Trimester | 439 nanogram per milliliter (ng/mL) | Standard Deviation 212 |
| Etravirine 200 mg Twice Daily | Predose (Trough) Plasma Concentration (C0h) | Postpartum (6-12 W) | 281 nanogram per milliliter (ng/mL) | Standard Deviation 193 |
| Rilpivirine 25 mg Once Daily | Predose (Trough) Plasma Concentration (C0h) | 3rd Trimester | 78.0 nanogram per milliliter (ng/mL) | Standard Deviation 39.1 |
| Rilpivirine 25 mg Once Daily | Predose (Trough) Plasma Concentration (C0h) | 2nd Trimester | 75.6 nanogram per milliliter (ng/mL) | Standard Deviation 36.2 |
| Rilpivirine 25 mg Once Daily | Predose (Trough) Plasma Concentration (C0h) | Postpartum (6-12 W) | 127 nanogram per milliliter (ng/mL) | Standard Deviation 97 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | 3rd Trimester | 824 nanogram per milliliter (ng/mL) | Standard Deviation 630 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | Postpartum (6-12 W) | 2811 nanogram per milliliter (ng/mL) | Standard Deviation 2296 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | 2nd Trimester | 540 nanogram per milliliter (ng/mL) | Standard Deviation 803 |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | 2nd Trimester | NA nanogram per milliliter (ng/mL) | — |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | Postpartum (6-12 W) | 134 nanogram per milliliter (ng/mL) | Standard Deviation 145 |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Predose (Trough) Plasma Concentration (C0h) | 3rd Trimester | 30.1 nanogram per milliliter (ng/mL) | Standard Deviation 51.5 |
Primary
Time to Reach the Maximum Plasma Concentration (Tmax)
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)
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 3rd Trimester | 3.00 hour (h) |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | Postpartum (6-12 W) | 3.00 hour (h) |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 2nd Trimester | 3.00 hour (h) |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 3rd Trimester | 4.07 hour (h) |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | Postpartum (6-12 W) | 5.04 hour (h) |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 2nd Trimester | 4.17 hour (h) |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | Postpartum (6-12 W) | 4.00 hour (h) |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 2nd Trimester | 4.00 hour (h) |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 3rd Trimester | 3.05 hour (h) |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | Postpartum (6-12 W) | 4.18 hour (h) |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 3rd Trimester | 6.00 hour (h) |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 2nd Trimester | 5.92 hour (h) |
| Etravirine 200 mg Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 3rd Trimester | 3.00 hour (h) |
| Etravirine 200 mg Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 2nd Trimester | 3.05 hour (h) |
| Etravirine 200 mg Twice Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | Postpartum (6-12 W) | 4.00 hour (h) |
| Rilpivirine 25 mg Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 3rd Trimester | 4.00 hour (h) |
| Rilpivirine 25 mg Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 2nd Trimester | 4.00 hour (h) |
| Rilpivirine 25 mg Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | Postpartum (6-12 W) | 4.00 hour (h) |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 3rd Trimester | 3.50 hour (h) |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | Postpartum (6-12 W) | 4.00 hour (h) |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 2nd Trimester | 4.00 hour (h) |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 2nd Trimester | 4.03 hour (h) |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | Postpartum (6-12 W) | 4.00 hour (h) |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Time to Reach the Maximum Plasma Concentration (Tmax) | 3rd Trimester | 3.50 hour (h) |
Secondary
Mean Change From Baseline in CD4+ Cell Count
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (2-5 weeks) | 127.9 10^6 Cells/Liter | Standard Error 28.53 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | 4 Weeks after Baseline | -14.8 10^6 Cells/Liter | Standard Error 23.16 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (6-12 weeks) | 174.5 10^6 Cells/Liter | Standard Error 44.98 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Baseline | 466.3 10^6 Cells/Liter | Standard Error 49.07 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | 3rd trimester | 83.5 10^6 Cells/Liter | Standard Error 29.45 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | 2nd trimester | 37.1 10^6 Cells/Liter | Standard Error 23.31 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Baseline | 497.9 10^6 Cells/Liter | Standard Error 64.6 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (2-5 weeks) | 186.0 10^6 Cells/Liter | Standard Error 43.51 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (6-12 weeks) | 323.0 10^6 Cells/Liter | Standard Error 63.99 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | 4 Weeks after Baseline | 116.3 10^6 Cells/Liter | Standard Error 62.41 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | 2nd trimester | 154.1 10^6 Cells/Liter | Standard Error 44.08 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in CD4+ Cell Count | 3rd trimester | 274.9 10^6 Cells/Liter | Standard Error 65.41 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | 3rd trimester | 77.30 10^6 Cells/Liter | Standard Error 30.803 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | 2nd trimester | 13.77 10^6 Cells/Liter | Standard Error 53.225 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | Baseline | 417.47 10^6 Cells/Liter | Standard Error 80.469 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (2-5 weeks) | 115.36 10^6 Cells/Liter | Standard Error 33.584 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | 4 Weeks after Baseline | 6.25 10^6 Cells/Liter | Standard Error 26.004 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (6-12 weeks) | 154.90 10^6 Cells/Liter | Standard Error 54.131 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | 2nd trimester | 39.21 10^6 Cells/Liter | Standard Error 36.496 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | Baseline | 495.79 10^6 Cells/Liter | Standard Error 79.322 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | 4 Weeks after Baseline | 24.00 10^6 Cells/Liter | Standard Error 56.912 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | 3rd trimester | 89.46 10^6 Cells/Liter | Standard Error 26.137 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (2-5 weeks) | 139.42 10^6 Cells/Liter | Standard Error 36.972 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (6-12 weeks) | 168.18 10^6 Cells/Liter | Standard Error 41.345 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in CD4+ Cell Count | 3rd trimester | 72.17 10^6 Cells/Liter | Standard Error 62.882 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Baseline | 594.17 10^6 Cells/Liter | Standard Error 108.151 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in CD4+ Cell Count | 2nd trimester | 13.29 10^6 Cells/Liter | Standard Error 34.445 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (6-12 weeks) | 244.67 10^6 Cells/Liter | Standard Error 100.74 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in CD4+ Cell Count | Postpartum (2-5 weeks) | 163 10^6 Cells/Liter | Standard Error 37.177 |
Secondary
Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Baseline | 2.12 Log 10 copies per milliliter (copies/mL) | Standard Error 0.179 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 4 Weeks after Baseline | -0.26 Log 10 copies per milliliter (copies/mL) | Standard Error 0.161 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 2nd trimester | -0.19 Log 10 copies per milliliter (copies/mL) | Standard Error 0.106 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 3rd trimester | -0.31 Log 10 copies per milliliter (copies/mL) | Standard Error 0.107 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (2-5 weeks) | -0.18 Log 10 copies per milliliter (copies/mL) | Standard Error 0.111 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (6-12 weeks) | 0.09 Log 10 copies per milliliter (copies/mL) | Standard Error 0.268 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Baseline | 1.88 Log 10 copies per milliliter (copies/mL) | Standard Error 0.089 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (6-12 weeks) | 0.11 Log 10 copies per milliliter (copies/mL) | Standard Error 0.265 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (2-5 weeks) | -0.04 Log 10 copies per milliliter (copies/mL) | Standard Error 0.146 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 2nd trimester | -0.16 Log 10 copies per milliliter (copies/mL) | Standard Error 0.104 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 3rd trimester | -0.23 Log 10 copies per milliliter (copies/mL) | Standard Error 0.105 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 4 Weeks after Baseline | -0.27 Log 10 copies per milliliter (copies/mL) | Standard Error 0.145 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 4 Weeks after Baseline | 0.18 Log 10 copies per milliliter (copies/mL) | Standard Error 0.182 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Baseline | 2.06 Log 10 copies per milliliter (copies/mL) | Standard Error 0.206 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (6-12 weeks) | 0.05 Log 10 copies per milliliter (copies/mL) | Standard Error 0.058 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (2-5 weeks) | 0.13 Log 10 copies per milliliter (copies/mL) | Standard Error 0.168 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 3rd trimester | 0.17 Log 10 copies per milliliter (copies/mL) | Standard Error 0.105 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 2nd trimester | 0.16 Log 10 copies per milliliter (copies/mL) | Standard Error 0.084 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 3rd trimester | 0.25 Log 10 copies per milliliter (copies/mL) | Standard Error 0.113 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 4 Weeks after Baseline | 0.20 Log 10 copies per milliliter (copies/mL) | Standard Error 0.172 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 2nd trimester | 0.16 Log 10 copies per milliliter (copies/mL) | Standard Error 0.074 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (6-12 weeks) | 0.08 Log 10 copies per milliliter (copies/mL) | Standard Error 0.138 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (2-5 weeks) | 0.20 Log 10 copies per milliliter (copies/mL) | Standard Error 0.273 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Baseline | 1.84 Log 10 copies per milliliter (copies/mL) | Standard Error 0.159 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 3rd trimester | 0.21 Log 10 copies per milliliter (copies/mL) | Standard Error 0.326 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | 2nd trimester | 0.1 Log 10 copies per milliliter (copies/mL) | Standard Error 0.233 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (6-12 weeks) | 0.23 Log 10 copies per milliliter (copies/mL) | Standard Error 0.347 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Baseline | 1.77 Log 10 copies per milliliter (copies/mL) | Standard Error 0.283 |
| Etravirine 200 mg Twice Daily | Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value | Postpartum (2-5 weeks) | 0.18 Log 10 copies per milliliter (copies/mL) | Standard Error 0.304 |
Secondary
Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result
The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).
Time frame: Birth to age 16 weeks
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result | 0 infants |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result | 0 infants |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result | 0 infants |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result | 0 infants |
| Etravirine 200 mg Twice Daily | Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result | 0 infants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 14 Participants |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 6 Participants |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 17 Participants |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 6 Participants |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 12 Participants |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 4 Participants |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 4 Participants |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 9 Participants |
| Etravirine 200 mg Twice Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 5 Participants |
| Etravirine 200 mg Twice Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 1 Participants |
Secondary
Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL)
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 2nd trimester Less than(<)50 copies/milliLiter(mL) | 6 Participants |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 3rd trimester: <50 copies/mL | 5 Participants |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (2-5 weeks): <50 copies/mL | 5 Participants |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (6-12 weeks): <50 copies/mL | 6 Participants |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 2nd trimester Less than(<)50 copies/milliLiter(mL) | 9 Participants |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (6-12 weeks): <50 copies/mL | 7 Participants |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 3rd trimester: <50 copies/mL | 8 Participants |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (2-5 weeks): <50 copies/mL | 8 Participants |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (6-12 weeks): <50 copies/mL | 8 Participants |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 3rd trimester: <50 copies/mL | 10 Participants |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (2-5 weeks): <50 copies/mL | 9 Participants |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 2nd trimester Less than(<)50 copies/milliLiter(mL) | 12 Participants |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 2nd trimester Less than(<)50 copies/milliLiter(mL) | 13 Participants |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 3rd trimester: <50 copies/mL | 13 Participants |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (6-12 weeks): <50 copies/mL | 10 Participants |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (2-5 weeks): <50 copies/mL | 9 Participants |
| Etravirine 200 mg Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (6-12 weeks): <50 copies/mL | 5 Participants |
| Etravirine 200 mg Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | Postpartum (2-5 weeks): <50 copies/mL | 5 Participants |
| Etravirine 200 mg Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 3rd trimester: <50 copies/mL | 5 Participants |
| Etravirine 200 mg Twice Daily | Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) | 2nd trimester Less than(<)50 copies/milliLiter(mL) | 6 Participants |
Secondary
Number of Participants With Resistance at Virological Failure
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Resistance at Virological Failure | 0 Participants |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Number of Participants With Resistance at Virological Failure | 0 Participants |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Resistance at Virological Failure | 0 Participants |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Number of Participants With Resistance at Virological Failure | 0 Participants |
| Etravirine 200 mg Twice Daily | Number of Participants With Resistance at Virological Failure | 0 Participants |
Secondary
Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Cord Plasma | 348.4 nanogram per milliliter (ng/mL) | Standard Deviation 322.9 |
| Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Maternal Plasma | 2149 nanogram per milliliter (ng/mL) | Standard Deviation 1140 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Cord Plasma | 17.07 nanogram per milliliter (ng/mL) | Standard Deviation 23.98 |
| Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Maternal Plasma | 316.7 nanogram per milliliter (ng/mL) | Standard Deviation 394.4 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Cord Plasma | 228 nanogram per milliliter (ng/mL) | Standard Deviation 302 |
| Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Maternal Plasma | 1663 nanogram per milliliter (ng/mL) | Standard Deviation 1691 |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Cord Plasma | NA nanogram per milliliter (ng/mL) | — |
| Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Maternal Plasma | 154 nanogram per milliliter (ng/mL) | Standard Deviation 274 |
| Etravirine 200 mg Twice Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Cord Plasma | 147 nanogram per milliliter (ng/mL) | Standard Deviation 61.3 |
| Etravirine 200 mg Twice Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Maternal Plasma | 421 nanogram per milliliter (ng/mL) | Standard Deviation 157 |
| Rilpivirine 25 mg Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Cord Plasma | 32.8 nanogram per milliliter (ng/mL) | Standard Deviation 16.7 |
| Rilpivirine 25 mg Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Maternal Plasma | 59.0 nanogram per milliliter (ng/mL) | Standard Deviation 34.7 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Maternal Plasma | 857 nanogram per milliliter (ng/mL) | Standard Deviation 885 |
| Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Cord Plasma | 125 nanogram per milliliter (ng/mL) | Standard Deviation 106 |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Cord Plasma | NA nanogram per milliliter (ng/mL) | — |
| Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily | Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery | Maternal Plasma | 74.5 nanogram per milliliter (ng/mL) | Standard Deviation 109 |