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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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In this study, the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) tablet is being made available to women who become pregnant while participating in study ING117172. Continuation of antiretroviral therapy (ART) is key to both mother and the unborn fetus in order to maintain virologic suppression in the mother (thereby decreasing the risk for maternal disease progression), but also to reduce the risk of maternal-fetal transmission of human immunodeficiency virus type 1 (HIV-1) to her unborn child. This study also offers the first opportunity to investigate the impact of pregnancy on DTG pharmacokinetics (PK). This is an open-label, single arm interventional study. The number of women that will be enrolled into this study cannot be established a priori, as unintended pregnancies cannot be determined in advance. The maximum number of women would include all of those women randomized to DTG/ABC/3TC FDC (approximately 237), though unintended pregnancies in all of these women would not be anticipated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTG/ABC/3TC | Experimental | All subjects will be administered DTG 50 milligrams (mg)/ABC 600 mg/3TC 300 mg FDC tablet once daily, with or without food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets | Drug | The DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablet is a purple, oval, biconvex tablets. The tablet contains 52.6 mg DTG sodium which is equivalent to 50 mg DTG free acid, 702 mg ABC sulphate which is equivalent to 600 mg ABC and 300 mg 3TC. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve at Steady State During a Dosing Interval (AUC [0-tau]) for Dolutegravir | Blood samples were collected at indicated timepoints for Pharmacokinetic (PK) analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
| Maximum Observed Plasma Concentration (Cmax) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
| Drug Concentration at the End of Dosing Interval (Ctau) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | 24 hours post dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
| Apparent Oral Clearance (CL/F) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
| Steady State Volume of Distribution (Vss/F) After Extravascular Administration for Dolutegravir |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (Tmax) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Oryol | 302040 | Russia | |||
| GSK Investigational Site |
In this study, 4 pregnant women were enrolled. Participant flow data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
This is a single arm open-label study in women who became pregnant while participating in study ING117172 (NCT01910402).
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| ID | Title | Description |
|---|---|---|
| FG000 | DTG/ABC/3TC - Mother | Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
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| ID | Title | Description |
|---|---|---|
| BG000 | DTG/ABC/3TC - Mother | Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Area Under the Plasma Concentration Time Curve at Steady State During a Dosing Interval (AUC [0-tau]) for Dolutegravir | Blood samples were collected at indicated timepoints for Pharmacokinetic (PK) analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population consists of all participants in the Safety Population (comprised of all participants [pregnant women] who received at least one dose of study treatment) who had at least 1 non-missing PK assessment. | Posted | Geometric Mean | 95% Confidence Interval | Micrograms*hours per milliliter | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
|
All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
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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 | DTG/ABC/3TC - Mother | Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | ViiV Healthcare | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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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 | Jun 19, 2018 | Dec 8, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2021 | Sep 5, 2022 | SAP_002.pdf |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| C106538 | abacavir |
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|
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. |
| Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
| Half-life (T1/2) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
| Number of Participants (Pregnant Women) With Maximum Severity of Post-Baseline Emergent Hematology Toxicities: Hemoglobin | Blood samples were collected for analysis of hemoglobin. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Number of participants (Pregnant Women) with maximum severity of post-Baseline emergent toxicities with respect to hemoglobin has been presented. | Up to Week 32 of study |
| Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Blood samples were collected for the analysis of chemistry parameters including ALT and AST. | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
| Change From Baseline in Chemistry Parameters: ALT and AST | Blood samples were collected for the analysis of chemistry parameters including ALT and AST. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
| Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine | Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
| Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine | Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
| Absolute Values of the Hematology Parameters: Hemoglobin | Blood samples were collected for the analysis of hematology parameters including hemoglobin. | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
| Change From Baseline in Hematology Parameters: Hemoglobin | Blood samples were collected for the analysis of hematology parameters including hemoglobin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
| Absolute Values of the Hematology Parameters: Leukocytes and Platelets | Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
| Change From Baseline in Hematology Parameters: Leukocytes and Platelets | Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
| Number of Participants (Pregnant Women) Who Discontinued the Treatment Due to Adverse Events (AE) | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment. Number of participants (pregnant women) who discontinued the treatment due to adverse events have been presented. | Up to Week 292 |
| Number of Participants (Pregnant Women) Demonstrated Congenital Malformations | Data for participants (pregnant women) demonstrated congenital malformations was reported. | At delivery (up to Week 40 of pregnancy) |
| Number of Participants (Pregnant Women) With Adverse Events (AE) as Per Severity Grades | Number of participants (pregnant women) with adverse events (AE) as per severity grades were presented. Grade 1 is mild, grade 2 is moderate, grade 3 is severe or medically significant but not immediately life-threatening and grade 4 is life-threatening consequences; urgent intervention required. | Up to 292 Weeks |
| Pre-dose Plasma Concentration (C0) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pre-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
| Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | At 3 hours and 24 hours post dose in Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
| Total DTG Concentrations in Plasma From Cord Blood and Maternal Blood at the Time of Delivery | Blood samples were collected at the time of delivery for PK analysis of dolutegravir. | At delivery (up to Week 40 of pregnancy) |
| Number of Participants (Pregnant Women) With Treatment-emergent Genotypic and/or Phenotypic Resistance Who Met Confirmed Virologic Withdrawal Criteria | Number of participants (pregnant women) with treatment-emergent genotypic and/or phenotypic resistance who met confirmed virologic withdrawal criteria are presented. Genotypic and phenotypic analyses were carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO) and reverse transcriptase (RT), or with their GeneSeq Integrase and PhenoSense Integrase assays. | Up to Week 32 of study |
| Number of Participants (Pregnant Women) With Live Birth Outcome Categories | Participants (pregnant women) with following live birth outcome categories are reported- Vaginal Birth, Planned Caesarean Section, Unscheduled Caesarean Section and Preterm Delivery. | At delivery (up to Week 40 of pregnancy) |
| Gestational Age of Infants | Gestational age is defined as the number of weeks between the first day of the mother's last normal menstrual period and the day of birth. Data for gestational age of infants has been presented. | At birth |
| Neonatal Length and Head Circumference at Birth | Data for neonatal length and head circumference at birth are reported. | At birth |
| Neonatal Weight at Birth | Data for neonatal weight at birth has been reported. | At birth |
| Number of Infants by Their Weight Categories at Birth | Weight of infants at birth were categorized as: Small for Gestational Age (SGA) defined neonates under the 10th percentile in weight, Appropriate for Gestational Age (AGA) characterized neonates between the 10th and 90th percentiles in weight and Large for Gestational Age (LGA) referred to neonates over the 90th percentile in weight. | At birth |
| Number of Infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 and 5 Minutes After Birth | APGAR is a quick test to assess the health of new born. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two with 2 being the best score, then summing up the values obtained from all five categories. APGAR score ranges from 0 to 10 (Higher score indicates better health) where a score of 7 and above is normal. Number of infants by APGAR score at 1 and 5 minutes after birth are presented. | 1 and 5 minutes after birth |
| Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit | Percentage of participants (pregnant women) with plasma HIV-1 RNA <50 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA. | At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study |
| Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit | Percentage of participants (pregnant women) with plasma HIV-1 RNA <400 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA. | At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study |
| Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit | Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study |
| Change From Baseline in CD4+ T Cell Counts by Visit | Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study |
| Number of Participants (Pregnant Women) With Disease Progression | Disease progression included HIV-associated conditions, acquired immunodeficiency syndrome (AIDS) and death. Number of participants (pregnant women) with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented. | Up to Week 32 of study |
| Saint Petersburg |
| 196645 |
| Russia |
| GSK Investigational Site | Madrid | 28046 | Spain |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population | Posted | Geometric Mean | 95% Confidence Interval | Micrograms per milliliter | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
|
|
|
| Primary | Drug Concentration at the End of Dosing Interval (Ctau) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population | Posted | Geometric Mean | 95% Confidence Interval | Nanograms per milliliter | 24 hours post dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
|
|
|
| Primary | Apparent Oral Clearance (CL/F) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population | Posted | Geometric Mean | 95% Confidence Interval | Liters per hour | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
|
|
|
| Primary | Steady State Volume of Distribution (Vss/F) After Extravascular Administration for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population | Posted | Geometric Mean | 95% Confidence Interval | Liters | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
|
|
|
| Primary | Half-life (T1/2) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population | Posted | Mean | Standard Deviation | Hours | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
|
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| Primary | Number of Participants (Pregnant Women) With Maximum Severity of Post-Baseline Emergent Hematology Toxicities: Hemoglobin | Blood samples were collected for analysis of hemoglobin. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Number of participants (Pregnant Women) with maximum severity of post-Baseline emergent toxicities with respect to hemoglobin has been presented. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 32 of study |
|
|
|
| Primary | Absolute Values of the Chemistry Parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Blood samples were collected for the analysis of chemistry parameters including ALT and AST. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | International units per Liter | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
|
|
|
| Primary | Change From Baseline in Chemistry Parameters: ALT and AST | Blood samples were collected for the analysis of chemistry parameters including ALT and AST. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | International units per Liter | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
|
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|
| Primary | Absolute Values of the Chemistry Parameters: Bilirubin and Creatinine | Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per Liter | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
|
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| Primary | Change From Baseline in Chemistry Parameters: Bilirubin and Creatinine | Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per Liter | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
|
|
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| Primary | Absolute Values of the Hematology Parameters: Hemoglobin | Blood samples were collected for the analysis of hematology parameters including hemoglobin. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Grams per Liter | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
|
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| Primary | Change From Baseline in Hematology Parameters: Hemoglobin | Blood samples were collected for the analysis of hematology parameters including hemoglobin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Grams per Liter | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
|
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| Primary | Absolute Values of the Hematology Parameters: Leukocytes and Platelets | Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Giga cells per Liter | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
|
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| Primary | Change From Baseline in Hematology Parameters: Leukocytes and Platelets | Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Giga cells per Liter | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study |
|
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| Primary | Number of Participants (Pregnant Women) Who Discontinued the Treatment Due to Adverse Events (AE) | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment. Number of participants (pregnant women) who discontinued the treatment due to adverse events have been presented. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment | Posted | Count of Participants | Participants | Up to Week 292 |
|
|
|
| Primary | Number of Participants (Pregnant Women) Demonstrated Congenital Malformations | Data for participants (pregnant women) demonstrated congenital malformations was reported. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. | Posted | Count of Participants | Participants | At delivery (up to Week 40 of pregnancy) |
|
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| Secondary | Time to Cmax (Tmax) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population | Posted | Mean | Standard Deviation | Hours | Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
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|
| Secondary | Pre-dose Plasma Concentration (C0) for Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population | Posted | Geometric Mean | 95% Confidence Interval | Nanograms per milliliter | Pre-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
|
|
|
| Secondary | Unbound DTG Concentrations in Plasma at 3 and 24 Hours Post Dose of Dolutegravir | Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. | Pharmacokinetic Population | Posted | Geometric Mean | 95% Confidence Interval | Micrograms per milliliter | At 3 hours and 24 hours post dose in Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum |
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|
|
| Secondary | Total DTG Concentrations in Plasma From Cord Blood and Maternal Blood at the Time of Delivery | Blood samples were collected at the time of delivery for PK analysis of dolutegravir. | Pharmacokinetic Population | Posted | Mean | Standard Deviation | Nanograms per milliliter | At delivery (up to Week 40 of pregnancy) |
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|
|
| Secondary | Number of Participants (Pregnant Women) With Treatment-emergent Genotypic and/or Phenotypic Resistance Who Met Confirmed Virologic Withdrawal Criteria | Number of participants (pregnant women) with treatment-emergent genotypic and/or phenotypic resistance who met confirmed virologic withdrawal criteria are presented. Genotypic and phenotypic analyses were carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO) and reverse transcriptase (RT), or with their GeneSeq Integrase and PhenoSense Integrase assays. | Intent-to-Treat Exposed (ITT-E) Population includes all participants (pregnant women) who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 32 of study |
|
|
|
| Secondary | Number of Participants (Pregnant Women) With Live Birth Outcome Categories | Participants (pregnant women) with following live birth outcome categories are reported- Vaginal Birth, Planned Caesarean Section, Unscheduled Caesarean Section and Preterm Delivery. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment. | Posted | Count of Participants | Participants | At delivery (up to Week 40 of pregnancy) |
|
|
|
| Secondary | Gestational Age of Infants | Gestational age is defined as the number of weeks between the first day of the mother's last normal menstrual period and the day of birth. Data for gestational age of infants has been presented. | Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Weeks | At birth |
|
|
|
| Secondary | Neonatal Length and Head Circumference at Birth | Data for neonatal length and head circumference at birth are reported. | Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Centimeter | At birth |
|
|
|
| Secondary | Neonatal Weight at Birth | Data for neonatal weight at birth has been reported. | Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Grams | At birth |
|
|
|
| Secondary | Number of Infants by Their Weight Categories at Birth | Weight of infants at birth were categorized as: Small for Gestational Age (SGA) defined neonates under the 10th percentile in weight, Appropriate for Gestational Age (AGA) characterized neonates between the 10th and 90th percentiles in weight and Large for Gestational Age (LGA) referred to neonates over the 90th percentile in weight. | Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment. | Posted | Count of Participants | Participants | At birth |
|
|
|
| Secondary | Number of Infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 and 5 Minutes After Birth | APGAR is a quick test to assess the health of new born. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two with 2 being the best score, then summing up the values obtained from all five categories. APGAR score ranges from 0 to 10 (Higher score indicates better health) where a score of 7 and above is normal. Number of infants by APGAR score at 1 and 5 minutes after birth are presented. | Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment. | Posted | Count of Participants | Participants | 1 and 5 minutes after birth |
|
|
|
| Secondary | Percentage of Participants (Pregnant Women) With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) by Visit | Percentage of participants (pregnant women) with plasma HIV-1 RNA <50 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA. | Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Number | Percentage of participants | At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study |
|
|
|
| Secondary | Percentage of Participants (Pregnant Women) With Plasma HIV-1 RNA <400 c/mL by Visit | Percentage of participants (pregnant women) with plasma HIV-1 RNA <400 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA. | Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles) | Posted | Number | Percentage of participants | At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study |
|
|
|
| Secondary | Absolute Values of Cluster of Differentiation 4 (CD4+) T Cell Counts by Visit | Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. | Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Cells per cubic millimeter | At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study |
|
|
|
| Secondary | Change From Baseline in CD4+ T Cell Counts by Visit | Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. | Intent-to-Treat Exposed Population. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Cells per cubic millimeter | Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study |
|
|
|
| Secondary | Number of Participants (Pregnant Women) With Disease Progression | Disease progression included HIV-associated conditions, acquired immunodeficiency syndrome (AIDS) and death. Number of participants (pregnant women) with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented. | Intent-to-Treat Exposed Population | Posted | Count of Participants | Participants | Up to Week 32 of study |
|
|
|
| Primary | Number of Participants (Pregnant Women) With Adverse Events (AE) as Per Severity Grades | Number of participants (pregnant women) with adverse events (AE) as per severity grades were presented. Grade 1 is mild, grade 2 is moderate, grade 3 is severe or medically significant but not immediately life-threatening and grade 4 is life-threatening consequences; urgent intervention required. | Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment | Posted | Count of Participants | Participants | Up to 292 Weeks |
|
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| 4 |
| 4 |
| EG001 | DTG/ABC/3TC - Infant | This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy. | 0 | 0 | 0 | 0 | 0 | 0 |
| Cystitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
|
|
|
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
|
| ALT, Week 8, n=4 |
|
|
| ALT, Week 12, n=4 |
|
|
| ALT, Week 16, n=4 |
|
|
| ALT, Week 20, n=4 |
|
|
| ALT, Week 24, n=1 |
|
|
| ALT, Week 32, n=2 |
|
|
| AST, Baseline (Day 1), n=4 |
|
|
| AST, Week 4, n=4 |
|
|
| AST, Week 8, n=4 |
|
|
| AST, Week 12, n=4 |
|
|
| AST, Week 16, n=4 |
|
|
| AST, Week 20, n=4 |
|
|
| AST, Week 24, n=1 |
|
|
| AST, Week 32, n=2 |
|
|
|
| ALT, Week 12, n=4 |
|
|
| ALT, Week 16, n=4 |
|
|
| ALT, Week 20, n=4 |
|
|
| ALT, Week 24, n=1 |
|
|
| ALT, Week 32, n=2 |
|
|
| AST, Week 4, n=4 |
|
|
| AST, Week 8, n=4 |
|
|
| AST, Week 12, n=4 |
|
|
| AST, Week 16, n=4 |
|
|
| AST, Week 20, n=4 |
|
|
| AST, Week 24, n=1 |
|
|
| AST, Week 32, n=2 |
|
|
|
| Bilirubin, Week 8, n=4 |
|
|
| Bilirubin, Week 12, n=4 |
|
|
| Bilirubin, Week 16, n=4 |
|
|
| Bilirubin, Week 20, n=4 |
|
|
| Bilirubin, Week 24, n=1 |
|
|
| Bilirubin, Week 32, n=2 |
|
|
| Creatinine, Baseline (Day 1), n=4 |
|
|
| Creatinine, Week 4, n=4 |
|
|
| Creatinine, Week 8, n=4 |
|
|
| Creatinine, Week 12, n=4 |
|
|
| Creatinine, Week 16, n=4 |
|
|
| Creatinine, Week 20, n=4 |
|
|
| Creatinine, Week 24, n=1 |
|
|
| Creatinine, Week 32, n=2 |
|
|
|
| Bilirubin, Week 12, n=4 |
|
|
| Bilirubin, Week 16, n=4 |
|
|
| Bilirubin, Week 20, n=4 |
|
|
| Bilirubin, Week 24, n=1 |
|
|
| Bilirubin, Week 32, n=2 |
|
|
| Creatinine, Week 4, n=4 |
|
|
| Creatinine, Week 8, n=4 |
|
|
| Creatinine, Week 12, n=4 |
|
|
| Creatinine, Week 16, n=4 |
|
|
| Creatinine, Week 20, n=4 |
|
|
| Creatinine, Week 24, n=1 |
|
|
| Creatinine, Week 32, n=2 |
|
|
|
| Week 8, n=4 |
|
|
| Week 12, n=4 |
|
|
| Week 16, n=4 |
|
|
| Week 20, n=4 |
|
|
| Week 24, n=1 |
|
|
| Week 32, n=2 |
|
|
|
| Week 12, n=4 |
|
|
| Week 16, n=4 |
|
|
| Week 20, n=4 |
|
|
| Week 24, n=1 |
|
|
| Week 32, n=2 |
|
|
|
| Leukocytes, Week 8, n=4 |
|
|
| Leukocytes, Week 12, n=4 |
|
|
| Leukocytes, Week 16, n=4 |
|
|
| Leukocytes, Week 20, n=4 |
|
|
| Leukocytes, Week 24, n=1 |
|
|
| Leukocytes, Week 32, n=2 |
|
|
| Platelets, Baseline (Day 1), n=4 |
|
|
| Platelets, Week 4, n=4 |
|
|
| Platelets, Week 8, n=4 |
|
|
| Platelets, Week 12, n=4 |
|
|
| Platelets, Week 16, n=4 |
|
|
| Platelets, Week 20, n=4 |
|
|
| Platelets, Week 24, n=1 |
|
|
| Platelets, Week 32, n=2 |
|
|
|
| Leukocytes, Week 12, n=4 |
|
|
| Leukocytes, Week 16, n=4 |
|
|
| Leukocytes, Week 20, n=4 |
|
|
| Leukocytes, Week 24, n=1 |
|
|
| Leukocytes, Week 32, n=2 |
|
|
| Platelets, Week 4, n=4 |
|
|
| Platelets, Week 8, n=4 |
|
|
| Platelets, Week 12, n=4 |
|
|
| Platelets, Week 16, n=4 |
|
|
| Platelets, Week 20, n=4 |
|
|
| Platelets, Week 24, n=1 |
|
|
| Platelets, Week 32, n=2 |
|
|
|
|
|
| At 24 hours post dose in Trimester 2 |
|
| At 24 hours post dose in Trimester 3 |
|
| At 24 hours post dose 8-12 Weeks postpartum |
|
| Title | Measurements |
|---|---|
|
| Preterm Delivery |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| 5 Minute, Score 7 to 10 |
|
|
| Week 12, n=4 |
|
|
| Week 16, n=4 |
|
|
| Week 20, n=4 |
|
|
| Week 24, n=2 |
|
|
| Week 28, n=1 |
|
|
| Week 32, n=2 |
|
|
|
| Week 12, n=4 |
|
|
| Week 16, n=4 |
|
|
| Week 20, n=4 |
|
|
| Week 24, n=2 |
|
|
| Week 28, n=1 |
|
|
| Week 32, n=2 |
|
|
|
| Week 8, n=4 |
|
|
| Week 12, n=4 |
|
|
| Week 16, n=4 |
|
|
| Week 20, n=4 |
|
|
| Week 24, n=2 |
|
|
| Week 28, n=1 |
|
|
| Week 32, n=2 |
|
|
|
| Week 12, n=4 |
|
|
| Week 16, n=4 |
|
|
| Week 20, n=4 |
|
|
| Week 24, n=2 |
|
|
| Week 28, n=1 |
|
|
| Week 32, n=2 |
|
|
| Title | Measurements |
|---|
|
| Grade 4 |
|