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Study to Evaluate the Pharmacokinetic (PK) Interactions Between GSK3640254 and Dolutegravir (DTG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03816696
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
This is an open-label, single-sequence, two-way drug interaction study to investigate the PK, safety and tolerability of GSK3640254 and DTG when administered alone or in combination in healthy subjects. Treatment of human immunodeficiency virus (HIV) infection frequently involves combination therapy. Data from this study will contribute to dosing recommendations when GSK3640254 and DTG are given in combination. The study will consist of a Screening period and 3 sequential treatment periods. Subjects will be administered DTG 50 milligrams (mg) once daily (QD) in Period 1 followed by GSK3640254 200 mg QD in Period 2. There will be a washout period of 4 days between Periods 1 and 2. In Period 3, subjects will be co-administered DTG 50 mg QD and GSK3640254 200 mg QD. The total duration of the study will be approximately 55 days, including Screening.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: GSK3640254 Drug: DTG Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Two-way Interaction Clinical Trial to Evaluate the Pharmacokinetic Interactions Between GSK3640254 and Dolutegravir in Healthy Subjects
Actual Study Start Date : January 23, 2019
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DTG followed by GSK3640254 followed by DTG+GSK3640254
Subjects will receive DTG 50 mg QD on Days 1 through 5 in Period 1 followed by a wash-out period of 4 days. Subjects will then receive GSK3640254 200 mg QD on Days 1 through 7 in Period 2 followed by co-administration of DTG 50 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Period 3.
Drug: GSK3640254
GSK3640254 will be available as 100 mg capsules. Subjects will be administered GSK3640254 200 mg QD via the oral route.

Drug: DTG
DTG will be available as 50 mg tablets. Subjects will be administered DTG 50 mg QD via the oral route.




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve from time 0 to the end of the dosing (AUC[0 to tau]) for DTG [ Time Frame: Period 1 (pre-dose on Days 2 to 4, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 5); Period 3 (pre-dose on Days 2 to 6, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 7) ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of DTG.

  2. Maximum observed concentration (Cmax) for DTG [ Time Frame: Period 1 (pre-dose on Days 2 to 4, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 5); Period 3 (pre-dose on Days 2 to 6, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 7) ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of DTG.

  3. Plasma concentration at the end of the dosing interval (Ctau) for DTG [ Time Frame: Period 1 (pre-dose on Days 2 to 4, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 5); Period 3 (pre-dose on Days 2 to 6, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 7) ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of DTG.

  4. AUC(0 to tau) for GSK3640254 [ Time Frame: Period 2 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 24 hours post-dose on Day 7); Period 3 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, and 96 hours post-dose on Day 7) ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

  5. Cmax for GSK3640254 [ Time Frame: Period 2 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 24 hours post-dose on Day 7); Period 3 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, and 96 hours post-dose on Day 7) ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

  6. Ctau for GSK3640254 [ Time Frame: Period 2 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 24 hours post-dose on Day 7); Period 3 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, and 96 hours post-dose on Day 7) ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.


Secondary Outcome Measures :
  1. Number of subjects with adverse events and serious adverse events (SAE) [ Time Frame: Up to Day 27 ]
    An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed before.

  2. Change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  3. Change from Baseline in absolute neutrophil count [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  4. Change from Baseline in hemoglobin level [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  5. Change from Baseline in hematocrit level [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  6. Change from Baseline in red blood cell (RBC) count [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  7. Change from Baseline in mean corpuscular hemoglobin (MCH) [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  8. Change from Baseline in mean corpuscular volume (MCV) [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  9. Change from Baseline in albumin, globulin and total protein levels [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  10. Change from Baseline in creatinine, total bilirubin, direct bilirubin and uric acid levels [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  11. Change from Baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP), lactate dehydrogenase (LDH), gamma-glutamyl transferase(GGT), creatine phosphokinase, amylase and lipase levels [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  12. Change from Baseline in blood urea nitrogen (BUN), glucose, chloride, potassium, sodium, phosphorus, carbon dioxide and calcium [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  13. Change from Baseline in anion gap [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  14. Change from Baseline in total cholesterol [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  15. Change from Baseline in triglyceride [ Time Frame: Baseline and up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  16. Change from Baseline in specific gravity of urine [ Time Frame: Baseline and up to Day 26 ]
    Urine samples will be collected for the assessment of urine parameters.

  17. Change from Baseline in potential of hydrogen (pH) of urine [ Time Frame: Baseline and up to Day 26 ]
    Urine samples will be collected for the assessment of urine parameters.

  18. Change from Baseline in glucose, protein, blood, ketone, nitrite bilirubin, urobilinogen, and leukocyte esterase levels in urine [ Time Frame: Baseline and up to Day 26 ]
    Urine samples will be collected to detect the presence of glucose, protein, blood, ketone, nitrite bilirubin, urobilinogen, and leukocyte esterase using the dipstick method.

  19. Absolute values of neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  20. Absolute values of absolute neutrophil count [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  21. Absolute values of hemoglobin level [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  22. Absolute values of hematocrit level [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  23. Absolute values of RBC count [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  24. Absolute values of MCH [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  25. Absolute values of MCV [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of hematology parameters.

  26. Absolute values of albumin, globulin and total protein levels [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  27. Absolute values of creatinine, total bilirubin, direct bilirubin and uric acid levels [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  28. Absolute values of ALT, AST, ALP, LDH, GGT, creatine phosphokinase, amylase and lipase levels [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  29. Absolute values of BUN, glucose, chloride, potassium, sodium, phosphorus, carbon dioxide and calcium [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  30. Absolute values of anion gap [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  31. Absolute values of total cholesterol [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  32. Absolute values of triglycerides [ Time Frame: Up to Day 26 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  33. Absolute values of specific gravity of urine [ Time Frame: Up to Day 26 ]
    Urine samples will be collected for the assessment of urine parameters.

  34. Absolute values of urine pH [ Time Frame: Up to Day 26 ]
    Urine samples will be collected for the assessment of urine parameters.

  35. Absolute values of glucose, protein, blood, ketone, nitrite bilirubin, urobilinogen, and leukocyte esterase levels in urine [ Time Frame: Up to Day 26 ]
    Urine samples will be collected to detect the presence of glucose, protein, blood, ketone, nitrite bilirubin, urobilinogen, and leukocyte esterase using the dipstick method.

  36. Change from Baseline in electrocardiogram (ECG) parameters [ Time Frame: Baseline and up to Day 26 ]
    Twelve-lead ECGs will be performed with the subject in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine. PR, QRS, QT, and QT interval corrected for heart rate using Fredericia's formula (QTcF) intervals will be measured.

  37. Absolute values of ECG parameters [ Time Frame: Up to Day 26 ]
    Twelve-lead ECGs will be performed with the subject in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured.

  38. Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: Baseline and up to Day 27 ]
    SBP and DBP will be assessed in the semi-recumbent position with a completely automated device.

  39. Absolute values of SBP and DBP [ Time Frame: Up to Day 27 ]
    SBP and DBP will be assessed in the semi-recumbent position with a completely automated device.

  40. Change from Baseline in heart rate [ Time Frame: Baseline and up to Day 27 ]
    Heart rate will be assessed in the semi-recumbent position with a completely automated device.

  41. Absolute values for heart rate [ Time Frame: Up to Day 27 ]
    Heart rate will be assessed in the semi-recumbent position with a completely automated device.

  42. Change from Baseline in respiratory rate [ Time Frame: Baseline and up to Day 27 ]
    Respiratory rate will be assessed in the semi-recumbent position after at least 5 minutes of rest for the subject.

  43. Absolute values of respiratory rate [ Time Frame: Up to Day 27 ]
    Respiratory rate will be assessed in the semi-recumbent position after at least 5 minutes of rest for the subject.

  44. Change from Baseline in oral temperature [ Time Frame: Baseline and up to Day 27 ]
    Temperature will be assessed in the semi-recumbent position with a completely automated device.

  45. Absolute values for oral temperature [ Time Frame: Up to Day 27 ]
    Temperature will be assessed in the semi-recumbent position with a completely automated device.

  46. Time of maximum observed concentration (Tmax) of GSK3640254 [ Time Frame: Period 2 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 24 hours post-dose on Day 7); Period 3 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, and 96 hours post-dose on Day 7) ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of GSK3640254

  47. Apparent terminal phase half-life (T1/2) of GSK3640254 [ Time Frame: Period 2 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 24 hours post-dose on Day 7); Period 3 (pre-dose on Days 4 to 6, pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, and 96 hours post-dose on Day 7) ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of GSK3640254

  48. Tmax of DTG [ Time Frame: Period 1 (pre-dose on Days 2 to 4, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 5); Period 3 (pre-dose on Days 2 to 6, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 7) ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of DTG.

  49. T1/2 of DTG [ Time Frame: Period 1 (pre-dose on Days 2 to 4, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 5); Period 3 (pre-dose on Days 2 to 6, pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 7) ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of DTG.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
  • Body weight >=50 kilograms (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kilograms per square meter (kg/m^2) (inclusive).
  • Male or female subjects can participate. 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, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.

Exclusion Criteria:

  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the subject unable to take oral study intervention.
  • Any history of significant underlying psychiatric disorder, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.
  • Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Medical Monitor.
  • Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject.
  • Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
  • Presence of Hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to starting study intervention.
  • Positive Hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention and positive on reflex to Hepatitis C ribonucleic acid (RNA).
  • Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.
  • ALT >1.5 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 <35 percent).
  • Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
  • Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory results and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.
  • A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention.
  • Unable to refrain from the use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and for the duration of the study.
  • Treatment with any vaccine within 30 days prior to receiving study intervention.
  • Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study.
  • Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer).
  • Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.
  • Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS).
  • Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the investigator or ViiV Healthcare (VH)/GlaxoSmithKline (GSK) Medical Monitor, will interfere with the safety for the individual subject.
  • Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate (males: <45 or >100 beats per minute [bpm] and females: <50 or >100 bpm); PR interval (<120 or >200 milliseconds [msec]); QRS duration (<70 or >110 msec); QTcF interval (males: >450 msec and females: >470 msec).
  • History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 grams of alcohol: a half-pint (equivalent to 240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.
  • Regular use of tobacco- or nicotine-containing products within 3 months prior to Screening.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816696


Locations
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United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
ViiV Healthcare
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03816696     History of Changes
Other Study ID Numbers: 209712
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ViiV Healthcare:
GSK3640254, dolutegravir, healthy subjects, two-way interaction, HIV
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Dolutegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents