Phase 2
N=14
A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03784079 ↗Enrolled (actual)
14
Serious AEs
5.9%
Results posted
Feb 2021
Primary outcome: Primary: Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11 — -8605.8; -100719.8; -3406.5 Copies per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK3640254 (Drug); Placebo matching GSK3640254 Mesylate salt (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11 |
-8605.8; -100719.8; -3406.5 | — |
| PRIMARY Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8 |
-48655.0; -37904.3; -64904.2; -123478.5 | — |
| SECONDARY Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) |
3; 5; 0; 1; 0; 0 | — |
| SECONDARY Part 2: Number of Participants With Non-SAEs and SAEs |
5; 4; 4; 0; 0; 0 | — |
| SECONDARY Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count |
0.005; -0.017; 0.015; -0.023; 0.058; -0.025 | — |
| SECONDARY Part 1: Change From Baseline in Hematology Parameter: Hemoglobin |
-4.2; -1.8; -1.0 | — |
| SECONDARY Part 1: Change From Baseline in Hematology Parameter: Hematocrit |
-0.0117; -0.0073; -0.0010 | — |
| SECONDARY Part 1: Change From Baseline in Hematology Parameter: Erythrocytes |
-0.10; -0.07; 0.00 | — |
| SECONDARY Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume |
0.0; -0.3; 0.0 | — |
| SECONDARY Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin |
-0.08; 0.03; -0.15 | — |
| SECONDARY Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte |
0.0042; 0.0012; 0.0020 | — |
| SECONDARY Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count |
0.010; 0.020; 0.022; -0.005; -0.066; -0.047 | — |
| SECONDARY Part 2: Change From Baseline in Hematology Parameter: Hemoglobin |
-8.0; -4.7; -1.7; -8.0 | — |
| SECONDARY Part 2: Change From Baseline in Hematology Parameter: Hematocrit |
-0.0230; -0.0123; -0.0058; -0.0315 | — |
| SECONDARY Part 2: Change From Baseline in Hematology Parameter: Erythrocytes |
-0.24; -0.17; -0.08; -0.30 | — |
| SECONDARY Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume |
-0.2; 0.2; 0.2; -2.0 | — |
| SECONDARY Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin |
-0.28; -0.05; -0.02; -0.05 | — |
| SECONDARY Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro |
0.0030; 0.0017; 0.0007; 0.0020 | — |
| SECONDARY Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol |
-0.20; 0.28; 0.00; -0.007; -0.027; 0.020 | — |
| SECONDARY Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) |
2.7; -1.7; 9.5; 10.5; -3.5; -4.0 | — |
| SECONDARY Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin |
1.77; -1.33; 0.00; -0.3; -2.0; 3.0 | — |
| SECONDARY Part 1: Change From Baseline in Chemistry Parameters: Protein |
-1.3; -1.0; 1.0 | — |
| SECONDARY Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase |
0.0; -2.0 | — |
| SECONDARY Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol |
-0.05; 0.18; -0.03; 0.50; -0.057; -0.027 | — |
| SECONDARY Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST |
-3.8; -1.2; -6.2; -1.0; -3.2; -0.7 | — |
| SECONDARY Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin |
1.35; -3.38; -0.17; -0.90; -0.3; 1.3 | — |
| SECONDARY Part 2: Change From Baseline in Chemistry Parameters: Protein |
-2.2; -0.8; 1.5; -2.0 | — |
| SECONDARY Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase |
-2.3; 0.8; 6.7; -10.0; -1.0; -2.2 | — |
| SECONDARY Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity |
0.0002; 0.0008; 0.0000 | — |
| SECONDARY Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen |
4.50; 0.00; 0.00 | — |
| SECONDARY Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) |
0.17; -0.33; -0.50 | — |
| SECONDARY Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity |
0.0010; -0.0022; 0.0018; -0.0110 | — |
| SECONDARY Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen |
0.00; 4.50; 0.00; 0.00 | — |
| SECONDARY Part 2: Change From Baseline in Urinalysis Parameter: pH |
0.17; -0.17; 0.08; 0.25 | — |
| SECONDARY Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
-2.5; 0.5; -1.5; -0.3; 0.8; 0.5 | — |
| SECONDARY Part 1: Change From Baseline in Respiratory Rate |
-1.0; 0.2; -1.0 | — |
| SECONDARY Part 1: Change From Baseline in Pulse Rate |
-5.2; 5.5; 6.0 | — |
| SECONDARY Part 2: Change From Baseline in SBP and DBP |
1.0; -2.2; 7.3; 1.0; -1.8; -1.0 | — |
| SECONDARY Part 2: Change From Baseline in Respiratory Rate |
-0.2; 0.2; -1.0; 0.5 | — |
| SECONDARY Part 2: Change From Baseline in Pulse Rate |
4.2; 2.0; 2.8; 10.5 | — |
| SECONDARY Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) |
-0.4; -7.6; -2.5; 1.4; -6.3; -11.5 | — |
| SECONDARY Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF |
9.7; -1.1; -7.3; -7.3; 6.1; -2.4 | — |
| SECONDARY Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count |
0.052; 0.056; 0.030; 0.057; 0.037; 0.045 | — |
| SECONDARY Part 1: Absolute Values for Hematology Parameter: Hemoglobin |
144.2; 135.4; 148.0; 140.0; 138.7; 147.0 | — |
| SECONDARY Part 1: Absolute Values for Hematology Parameter: Hematocrit |
0.4338; 0.4112; 0.4395; 0.4222; 0.4158; 0.4385 | — |
| SECONDARY Part 1: Absolute Values for Hematology Parameter: Erythrocytes |
4.90; 4.58; 4.90; 4.80; 4.63; 4.90 | — |
| SECONDARY Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume |
88.5; 90.2; 90.0; 88.5; 90.0; 90.0 | — |
| SECONDARY Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin |
29.38; 29.64; 30.25; 29.30; 29.97; 30.10 | — |
| SECONDARY Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro |
0.0137; 0.0078; 0.0110; 0.0178; 0.0088; 0.0130 | — |
| SECONDARY Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count |
0.042; 0.042; 0.030; 0.040; 0.050; 0.062 | — |
| SECONDARY Part 2: Absolute Values for Hematology Parameter: Hemoglobin |
136.3; 149.2; 141.2; 147.0; 129.4; 144.5 | — |
| SECONDARY Part 2: Absolute Values for Hematology Parameter: Hematocrit |
0.4037; 0.4505; 0.4222; 0.4330; 0.3826; 0.4382 | — |
| SECONDARY Part 2: Absolute Values for Hematology Parameter: Erythrocytes |
4.53; 5.17; 4.74; 4.80; 4.26; 5.00 | — |
| SECONDARY Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume |
88.8; 87.8; 89.2; 91.0; 89.6; 88.0 | — |
| SECONDARY Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin |
30.07; 29.15; 29.80; 30.95; 30.22; 29.10 | — |
| SECONDARY Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro |
0.0102; 0.0082; 0.0108; 0.0070; 0.0124; 0.0098 | — |
| SECONDARY Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol |
5.28; 4.88; 5.40; 5.08; 5.17; 5.40 | — |
| SECONDARY Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST |
31.3; 19.7; 20.0; 34.0; 18.0; 29.5 | — |
| SECONDARY Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin |
82.05; 81.35; 88.40; 83.82; 80.02; 88.40 | — |
| SECONDARY Part 1: Absolute Values for Chemistry Parameters: Protein |
72.2; 70.3; 69.0; 70.8; 69.3; 70.0 | — |
| SECONDARY Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase |
57.0; 57.0; 28.5; 26.5 | — |
| SECONDARY Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol |
4.68; 4.72; 4.80; 4.90; 4.63; 4.90 | — |
| SECONDARY Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST |
18.3; 17.8; 33.2; 34.5; 14.5; 16.7 | — |
| SECONDARY Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin |
71.30; 73.67; 73.52; 86.65; 72.65; 70.28 | — |
| SECONDARY Part 2: Absolute Values for Chemistry Parameters: Protein |
78.8; 73.3; 76.7; 73.5; 76.7; 72.5 | — |
| SECONDARY Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase |
47.2; 51.0; 55.2; 56.0; 44.8; 51.8 | — |
| SECONDARY Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity |
1.0238; 1.0233; 1.0240; 1.0240; 1.0242; 1.0240 | — |
| SECONDARY Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen |
3.40; 3.40; 3.40; 7.90; 3.40; 3.40 | — |
| SECONDARY Part 1: Absolute Values for Urinalysis Parameter: pH |
5.67; 5.75; 5.75; 5.83; 5.42; 5.25 | — |
| SECONDARY Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity |
1.0223; 1.0272; 1.0255; 1.0375; 1.0233; 1.0250 | — |
| SECONDARY Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen |
3.40; 3.40; 3.40; 3.40; 3.40; 7.90 | — |
| SECONDARY Part 2: Absolute Values for Urinalysis Parameter: pH |
5.33; 5.83; 5.25; 5.50; 5.50; 5.67 | — |
| SECONDARY Part 1: Absolute Values for SBP and DBP |
120.2; 121.8; 106.0; 117.7; 122.3; 104.5 | — |
| SECONDARY Part 1: Absolute Values for Respiratory Rate |
16.0; 16.2; 15.0; 15.0; 16.3; 14.0 | — |
| SECONDARY Part 1: Absolute Values for Pulse Rate |
81.8; 65.8; 60.0; 76.7; 71.3; 66.0 | — |
| SECONDARY Part 2: Absolute Values for SBP and DBP |
117.0; 116.5; 112.2; 105.5; 118.0; 114.3 | — |
| SECONDARY Part 2: Absolute Values for Respiratory Rate |
17.3; 17.2; 17.2; 16.0; 17.2; 17.3 | — |
| SECONDARY Part 2: Absolute Values for Pulse Rate |
68.3; 74.5; 77.0; 64.5; 72.5; 76.5 | — |
| SECONDARY Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals |
136.6; 168.4; 176.5; 136.2; 160.8; 174.0 | — |
| SECONDARY Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals |
156.8; 162.9; 162.8; 144.3; 166.5; 161.8 | — |
| SECONDARY Part 1: Area Under the Plasma Concentration Time Curve From Zero to 24 (AUC[0-24]) Following Administration of GSK3640254 on Day 1 |
0.6946; 12.3929 | — |
| SECONDARY Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK3640254 on Day 1 |
0.0591; 0.9381 | — |
| SECONDARY Part 1: Time to Maximum Observed Concentration (Tmax) Following Administration of GSK3640254 on Day 1 |
2.9250; 5.5250 | — |
| SECONDARY Part 1: Concentration at 24 Hours Post-dose (C24) Following Administration of GSK3640254 on Day 1 |
0.0180; 0.3553 | — |
| SECONDARY Part 1: Absorption Lag Time (Tlag) Following Administration of GSK3640254 on Day 1 |
0.500; 0.000 | — |
| SECONDARY Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1 |
3.2527; 6.1228; 14.0335 | — |
| SECONDARY Part 2: Cmax Following Administration of GSK3640254 on Day 1 |
0.2316; 0.4329; 0.9178 | — |
| SECONDARY Part 2: Tmax Following Administration of GSK3640254 on Day 1 |
4.4167; 4.0750; 5.5083 | — |
| SECONDARY Part 2: C24 Following Administration of GSK3640254 on Day 1 |
0.0951; 0.1856; 0.4207 | — |
| SECONDARY Part 2: Tlag Following Administration of GSK3640254 on Day 1 |
0.483; 0.000; 0.000 | — |
| SECONDARY Part 1: Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 |
0.9082; 27.9363 | — |
| SECONDARY Part 1: Cmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 |
0.0549; 1.8559 | — |
| SECONDARY Part 1: Tmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 |
4.0167; 5.4833 | — |
| SECONDARY Part 1: Pre-dose Concentration (C0) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 |
0.0268; 0.6928 | — |
| SECONDARY Part 1: Concentration at End of Dosing Interval (Ctau) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 |
0.0267; 0.7033 | — |
| SECONDARY Part 1: Apparent Terminal Phase Half-life (t1/2) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 |
NA; NA | — |
| SECONDARY Part 1: Apparent Oral Clearance (CL/F) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 |
11010.5393; 7159.1443 | — |
| SECONDARY Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7 |
7.4626; 11.8256; 29.2952 | — |
| SECONDARY Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7 |
0.4692; 0.7470; 1.8574 | — |
| SECONDARY Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7 |
4.0583; 4.5750; 4.0750 | — |
| SECONDARY Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7 |
0.2155; 0.3575; 0.7520 | — |
| SECONDARY Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7 |
0.2187; 0.3599; 0.7979 | — |
| SECONDARY Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7 |
NA; NA; NA | — |
| SECONDARY Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7 |
5360.0526; 6764.9862; 4778.9430 | — |
| SECONDARY Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau) |
12071.4; -113331.4; -48655.0; -37904.3; -64861.5 | — |
| SECONDARY Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax |
12071.4; -113331.4; -48655.0; -37904.3; -64861.5 | — |
| SECONDARY Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau |
12071.4; -113331.4; -48655.0; -37904.3; -64861.5 | — |
| SECONDARY Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 |
1.5352; 2.2542; 0.9287; 1.9785; 1.4790; 1.9796 | — |
| SECONDARY Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 |
2.2943; 1.9314; 2.0875; 2.0258; 1.7258; 2.0236 | — |
| SECONDARY Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on AUC(0-24) |
1.018 | — |
| SECONDARY Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on Cmax |
0.964 | — |
| SECONDARY Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on C24 |
1.061 | — |
| SECONDARY Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on AUC(0-tau) |
1.179 | — |
| SECONDARY Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Cmax |
1.204 | — |
| SECONDARY Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Ctau |
1.137 | — |
Summary
Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection. This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/ pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1 of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2) and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could be modified based on data obtained in Part 1. Subjects will also receive placebo to match GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24). A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.
Eligibility Criteria
Inclusion Criteria
- Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Subjects who are healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, laboratory tests, and cardiac monitoring.
- Screening Cluster of designation 4 positive (CD4+) T-cell count >=350 cells per millimeter cube (cells/mm^3).
- Documented HIV infection and Screening plasma HIV-1 RNA >=5000 copies/milliliter (mL). A single repeat of this test is allowed within a single Screening period to determine eligibility.
- Treatment-naive: No anti-retrovirals (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
- Body weight >=50.0 kilograms (kg) (110 Pounds) for men and >=45.0 kg (99 pounds) for women and body mass index (BMI) within the range 18.5-31.0 kg/meter square (kg/m^2) (inclusive).
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).
- Capable of giving signed informed consent.
- For subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion Criteria
- Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to starting study treatment.
- Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study treatment and positive on reflex to Hepatitis C RNA.
- ALT >2 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single Screening period to determine eligibility.
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin 6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy ( 100 beats per minute (bpm) for males and 100 bpm for females; PR Interval of 200 milliseconds (msec) for both males and females; QRS duration of 110 msec for both males and females; QT interval corrected (QTc) for heart rate according to Fridericia's formula (QTcF) of >450 msec for males and >470 msec for females. A heart rate from 100 to 110 bpm can be rechecked by electrocardiogram or vitals within 30 minutes to verify eligibility. QTcF is either machine read or manually over-read.
- Any significant arrhythmia or electrocardiogram finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the Investigator OR ViiV Medical Monitor, will interfere with the safety for the individual subject.
Data sourced from ClinicalTrials.gov (NCT03784079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.