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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001073-23 | EudraCT Number |
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The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B/F/TAF | Experimental | Pregnant women participants will receive fixed dose combination (FDC) tablet of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum). |
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| Neonates | No Intervention | Neonates who will be born to women participants in the study will be followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates that participate in the study will be treated with the study drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Drug | 50/200/25 mg FDC tablet administered orally once daily without regard to food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | United States | ||
| Triple O Research Institute, P.A. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37939141 | Derived | Zhang H, Hindman JT, Lin L, Davis M, Shang J, Xiao D, Avihingsanon A, Arora P, Palaparthy R, Girish S, Marathe DD. A study of the pharmacokinetics, safety, and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed pregnant women with HIV. AIDS. 2024 Jan 1;38(1):F1-F9. doi: 10.1097/QAD.0000000000003783. Epub 2023 Nov 22. |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
18 months after study completion
A secured external environment with username, password, and RSA code.
33 pregnant women were enrolled in the B/F/TAF group. Neonates born to these women were also enrolled in the study for follow up. A total of 29 neonate participants were enrolled.
Participants were enrolled at study sites in the Dominican Republic, Thailand and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | B/F/TAF | Pregnant women participants received fixed dose combination (FDC) tablet of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2019 | Dec 6, 2023 |
Study model 'single group' is selected as the Neonates group was only followed up but not treated.
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| PK Parameter: AUClast of BIC, FTC, and TAF | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| PK Parameter: Cmax of BIC, FTC, and TAF | Cmax is defined as the maximum observed concentration of drug during the dosing interval. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| PK Parameter: Ctau of BIC and FTC | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| PK Parameter: Clast of BIC, FTC, and TAF | Clast is defined as the last observable concentration of drug. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| PK Parameter: Tmax of BIC, FTC, and TAF | Tmax is defined as the time (observed time point) of Cmax. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| PK Parameter: t1/2 of BIC, FTC, and TAF | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| PK Parameter: CLss/F of BIC, FTC, and TAF | CLss/F is defined as the apparent steady-state oral clearance following administration of the drug. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| PK Parameter: Vz/F of BIC, FTC, and TAF | Vz/F is defined as the apparent volume of distribution of the drug. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| PK Parameter: λz of BIC, FTC, and TAF | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at the Time of Delivery Using the Missing = Excluded Approach in B/F/TAF Group | The percentage of participants with HIV-1 RNA < 50 copies/mL at the time of delivery was analyzed in B/F/TAF group using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). | At time of delivery |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Birth Using the Missing = Excluded Approach in Neonates | The percentage of participants with HIV-1 RNA < 50 copies/mL at the time of birth was analyzed in neonates using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). | At birth |
| West Palm Beach |
| Florida |
| 33407 |
| United States |
| Instituto Dominicano de Estudios Virologics (IDEV) | Santo Domingo | 10103 | Dominican Republic |
| Faculty of Medicine Siriraj Hospital | Bangkok Noi | 10700 | Thailand |
| Faculty of Medicine-Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Bamrasnaradura Infectious Diseases Institute | Nonthaburi | 11000 | Thailand |
| Research Institute for Health Sciences, Chiang Mai University | Nonthaburi | 50200 | Thailand |
| Thai Red Cross AIDS Research Centre | Pathumwan | 10330 | Thailand |
| Neonates |
Neonates born to women participants in the study were followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates participating in the study were treated with the study drug. |
| COMPLETED |
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| NOT COMPLETED |
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B/F/TAF: Safety analysis set included all adult participants who took at least 1 dose of study drug (B/F/TAF). Neonates: Safety analysis set included neonates who were born to women participating in the study and had been enrolled into the study as well.
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| ID | Title | Description |
|---|---|---|
| BG000 | B/F/TAF | Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum). |
| BG001 | Neonates | Neonates born to women participants in the study were followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates participating in the study were treated with the study drug. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | PK analysis set included all enrolled adult participants who took at least 1 dose of study drug (B/F/TAF), and had at least 1 non-missing concentration value reported by the PK laboratory for the corresponding analytes (BIC, FTC, TAF, and tenofovir diphosphate [TFV-DP]). Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | hours*nanograms per milliliter (h*ng/mL) | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: AUClast of BIC, FTC, and TAF | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: Cmax of BIC, FTC, and TAF | Cmax is defined as the maximum observed concentration of drug during the dosing interval. | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: Ctau of BIC and FTC | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: Clast of BIC, FTC, and TAF | Clast is defined as the last observable concentration of drug. | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: Tmax of BIC, FTC, and TAF | Tmax is defined as the time (observed time point) of Cmax. | Participants in the PK analysis set with available data were analyzed. | Posted | Median | Full Range | h | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: t1/2 of BIC, FTC, and TAF | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. | Participants in the PK analysis set with available data were analyzed. | Posted | Median | Full Range | h | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: CLss/F of BIC, FTC, and TAF | CLss/F is defined as the apparent steady-state oral clearance following administration of the drug. | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | mL/h | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: Vz/F of BIC, FTC, and TAF | Vz/F is defined as the apparent volume of distribution of the drug. | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | mL | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | PK Parameter: λz of BIC, FTC, and TAF | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. | Participants in the PK analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | 1/h | Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at the Time of Delivery Using the Missing = Excluded Approach in B/F/TAF Group | The percentage of participants with HIV-1 RNA < 50 copies/mL at the time of delivery was analyzed in B/F/TAF group using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). | Full analysis set included all adult participants who enrolled into the study and took at least 1 dose of study drug (B/F/TAF). Participants in the full analysis set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | At time of delivery |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Birth Using the Missing = Excluded Approach in Neonates | The percentage of participants with HIV-1 RNA < 50 copies/mL at the time of birth was analyzed in neonates using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). | Neonate full analysis set included neonates who were born to women participating in the study and had been enrolled into the study as well. Participants in the neonate full analysis set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | At birth |
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All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating & had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug & no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B/F/TAF | Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum). | 0 | 33 | 6 | 33 | 19 | 33 |
| EG001 | Neonates | Neonates born to women participants in the study were followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates participating in the study were treated with the study drug. | 0 | 29 | 5 | 29 | 4 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nonreassuring foetal heart rate pattern | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Accessory auricle | Congenital, familial and genetic disorders | MedDRA (25.1) | Systematic Assessment |
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| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (25.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
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| Sepsis neonatal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
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| False labour | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Neonatal asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
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| Foetal heart rate deceleration abnormality | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
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| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (25.1) | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2022 | Jan 2, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Other |
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| White |
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| United States |
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| Dominican Republic |
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| Week 6 Post-partum |
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| Week 12 Post-partum |
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| GLSM ratio (%) |
| 44.65 |
| 2-Sided |
| 90 |
| 40.04 |
| 49.79 |
| Other |
| BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%). | GLSM ratio (%) | 40.57 | 2-Sided | 90 | 36.77 | 44.76 | Other |
| BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%). | GLSM ratio (%) | 44.40 | 2-Sided | 90 | 39.95 | 49.34 | Other |
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