A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women
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ClinicalTrials.gov Identifier: NCT00855335 |
Recruitment Status
:
Completed
First Posted
: March 4, 2009
Results First Posted
: September 15, 2017
Last Update Posted
: February 14, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV HIV Infections Pregnancy | Drug: Darunavir Drug: Ritonavir Drug: Etravirine Drug: Rilpivirine Drug: Darunavir/Cobicistat (FDC) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | April 9, 2009 |
Actual Primary Completion Date : | August 11, 2016 |
Actual Study Completion Date : | August 11, 2016 |

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.
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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.
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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.
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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.
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Experimental: Group 3: Etravirine
TMC125 (etravirine) Two 200 mg tablets twice daily up to 12 weeks postpartum.
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Drug: Etravirine
Two 200 mg tablets twice daily up to 12 weeks postpartum.
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Experimental: Group 4: Rilpivirine
TMC278 (rilpivirine) One 25 mg tablet once daily up to 12 weeks postpartum.
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Drug: Rilpivirine
One 25 mg tablet once daily up to 12 weeks postpartum.
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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.
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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.
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- Predose (Trough) Plasma Concentration (C0h) [ Time Frame: 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) [ 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) ]The Cmin is the minimum observed plasma concentration.
- Maximum Plasma Concentration (Cmax) [ 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) ]The Cmax is the maximum observed plasma concentration.
- Time to Reach the Maximum Plasma Concentration (Tmax) [ 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) ]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) [ 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) ]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) [ 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) ]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).
- Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855335
United States, Florida | |
Daytona Beach, Florida, United States | |
Jacksonville, Florida, United States | |
Miami, Florida, United States | |
Pensacola, Florida, United States | |
Port Saint Lucie, Florida, United States | |
West Palm Beach, Florida, United States | |
United States, Georgia | |
Savannah, Georgia, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Massachusetts | |
Springfield, Massachusetts, United States | |
United States, Michigan | |
Dearborn, Michigan, United States | |
United States, New York | |
Bronx, New York, United States | |
Syracuse, New York, United States | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States | |
Greensboro, North Carolina, United States | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States | |
United States, Texas | |
Bellaire, Texas, United States | |
Puerto Rico | |
San Juan Pr, Puerto Rico |
Study Director: | Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen Scientific Affairs, LLC |
ClinicalTrials.gov Identifier: | NCT00855335 History of Changes |
Other Study ID Numbers: |
CR015442 TMC114HIV3015 ( Other Identifier: Janssen Scientific Affairs, LLC ) |
First Posted: | March 4, 2009 Key Record Dates |
Results First Posted: | September 15, 2017 |
Last Update Posted: | February 14, 2018 |
Last Verified: | February 2018 |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Janssen Scientific Affairs, LLC:
HIV-1 HIV Pregnancy Postpartum Human immunodeficiency virus PREZISTA INTELENCE NORVIR TMC114 |
TMC125 darunavir ritonavir etravirine rilpivirine TMC278 Cobicistat treatment experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Darunavir Cobicistat Rilpivirine |
Etravirine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |