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Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03984825
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
This is an open-label, single-sequence, 1-way drug-drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics of a combination oral contraceptive containing ethinyl estradiol (EE) and levonorgestrel (LNG). Effective contraception for women infected with human immunodeficiency virus (HIV) is important in the prevention of unplanned pregnancies. The study will consist of a screening period of 28 days, check-in (Day -4), a run-in period and a treatment period. During the run-in period, subjects will be administered Portia® (0.03 milligrams [mg] EE/0.15 mg LNG) once daily on Days -3 to -1. Subjects will then be administered Portia once daily on Days 1 to 10 of treatment period A followed by administration of Portia once daily along with GSK3640254 200 mg on Days 11 to 21 of treatment period B. The duration of the study is approximately 8 weeks, including Screening and Run-in. Portia is a registered trademark of Teva Pharmaceuticals USA.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Coadministration of GSK3640254 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Subjects
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : September 3, 2019
Estimated Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Portia followed by Portia co-administered with GSK3640254
Subjects will be administered Portia (0.03 mg EE/0.15 mg LNG) once daily on Days -3 to -1 during run-in period and on Days 1 to 10 in treatment period A. Subjects will then receive Portia (0.03 mg EE/0.15 mg LNG) co-administered with GSK3640254 200 mg once daily on Days 11 to 21 in treatment period B.
Drug: GSK3640254
GSK3640254 will be available as a 100 mg capsule. Subjects will be administered 200 mg GSK3640254 once daily via the oral route on Days 11 to 21.

Drug: Portia
Portia will be available in the form of tablets containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel.




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 EE [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of EE.

  2. AUC(0 to tau) for LNG [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of LNG.

  3. Maximum observed concentration (Cmax) for EE [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of EE.

  4. Cmax for LNG [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of LNG.

  5. Plasma concentration at the end of the dosing (Ctau) for EE [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of EE.

  6. Ctau for LNG [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of LNG.


Secondary Outcome Measures :
  1. Serum progesterone levels [ Time Frame: Up to Day 22 ]
    Venous blood samples will be collected for measurement of serum progesterone levels.

  2. Serum follicle-stimulating hormone (FSH) levels [ Time Frame: Up to Day 22 ]
    Venous blood samples will be collected for measurement of serum FSH levels.

  3. Serum luteinizing hormone (LH) levels [ Time Frame: Up to Day 22 ]
    Venous blood samples will be collected for measurement of serum LH levels.

  4. AUC(0 to tau) for GSK3640254 [ Time Frame: Up to Day 25 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

  5. Cmax for GSK3640254 [ Time Frame: Up to Day 25 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

  6. Ctau for GSK3640254 [ Time Frame: Up to Day 25 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

  7. Time of maximum observed concentration (Tmax) for GSK3640254 [ Time Frame: Up to Day 25 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

  8. Apparent terminal phase half-life (T1/2) for GSK3640254 [ Time Frame: Up to Day 25 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3640254.

  9. Tmax for EE [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of EE.

  10. Tmax for LNG [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of LNG.

  11. T1/2 for EE [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of EE.

  12. T1/2 for LNG [ Time Frame: Up to Day 24 ]
    Blood samples will be collected at the indicated time points for pharmacokinetic analysis of LNG.

  13. Number of subjects with adverse events and serious adverse events (SAE) [ Time Frame: Up to Day 25 ]
    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.

  14. Change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of hematology parameters

  15. Change from Baseline in hemoglobin level [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of hematology parameters

  16. Change from Baseline in hematocrit level [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of hematology parameters

  17. Change from Baseline in red blood cell (RBC) count [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of hematology parameters

  18. Change from Baseline in mean corpuscular hemoglobin (MCH) [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of hematology parameters

  19. Change from Baseline in mean corpuscular volume (MCV) [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of hematology parameters

  20. Change from Baseline in albumin, globulin and total protein levels [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  21. Change from Baseline in creatinine, total bilirubin, direct bilirubin and uric acid levels [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  22. Change from Baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), gamma-glutamyl transferase(GGT), creatine phosphokinase, amylase and lipase levels [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  23. Change from Baseline in blood urea nitrogen (BUN), glucose, chloride, potassium, sodium, phosphorus, carbon dioxide and calcium [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  24. Change from Baseline in anion gap [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  25. Change from Baseline in total cholesterol [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  26. Change from Baseline in triglycerides [ Time Frame: Baseline and up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  27. Change from Baseline in specific gravity of urine [ Time Frame: Baseline and up to Day 24 ]
    Urine samples will be collected for the assessment of urine parameters.

  28. Change from Baseline in potential of hydrogen (pH) of urine [ Time Frame: Baseline and up to Day 24 ]
    Urine samples will be collected for the assessment of urine parameters.

  29. Change from Baseline in glucose, protein, blood, ketone, nitrite, bilirubin, urobilinogen, and leukocyte esterase levels in urine [ Time Frame: Baseline and up to Day 24 ]
    Urine samples will be collected for the assessment of urine parameters.

  30. Absolute values of neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count [ Time Frame: Up to Day 24 ]
    Blood samples will be collected for the assessment of hematology parameters.

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

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

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

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

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

  36. Absolute values of albumin, globulin and total protein levels [ Time Frame: Up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  37. Absolute values of creatinine, total bilirubin, direct bilirubin and uric acid levels [ Time Frame: Up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  38. Absolute values of ALT, AST, ALP, LDH, GGT, creatine phosphokinase, amylase and lipase levels [ Time Frame: Up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  39. Absolute values of BUN, glucose, chloride, potassium, sodium, phosphorus, carbon dioxide and calcium [ Time Frame: Up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  40. Absolute values of anion gap [ Time Frame: Up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  41. Absolute values of total cholesterol [ Time Frame: Up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  42. Absolute values of triglycerides [ Time Frame: Up to Day 24 ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  43. Absolute values of specific gravity of urine [ Time Frame: Up to Day 24 ]
    Urine samples will be collected for the assessment of urine parameters.

  44. Absolute values of urine pH [ Time Frame: Up to Day 24 ]
    Urine samples will be collected for the assessment of urine parameters.

  45. Absolute values of glucose, protein, blood, ketone, nitrite bilirubin, urobilinogen, and leukocyte esterase levels in urine [ Time Frame: Up to Day 24 ]
    Urine samples will be collected for the assessment of urine parameters.

  46. Change from Baseline in electrocardiogram (ECG) parameters [ Time Frame: Baseline and up to Day 24 ]
    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 Fridericia's formula (QTcF) intervals will be measured.

  47. Absolute values of ECG parameters [ Time Frame: Up to Day 24 ]
    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.

  48. Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: Baseline and up to Day 24 ]
    SBP and DBP will be assessed in the semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.

  49. Absolute values of SBP and DBP [ Time Frame: Up to Day 24 ]
    SBP and DBP will be assessed in the semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.

  50. Change from Baseline in pulse rate [ Time Frame: Baseline and up to Day 24 ]
    Pulse rate will be assessed in the semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.

  51. Absolute values of pulse rate [ Time Frame: Up to Day 24 ]
    Pulse rate will be assessed in the semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.

  52. Change from Baseline in temperature [ Time Frame: Baseline and up to Day 24 ]
    Oral temperature will be assessed.

  53. Absolute values of temperature [ Time Frame: Up to Day 24 ]
    Oral temperature will be assessed.

  54. Change from Baseline in respiratory rate [ Time Frame: Baseline and up to Day 24 ]
    Respiratory rate will be assessed.

  55. Absolute values of respiratory rate [ Time Frame: Up to Day 24 ]
    Respiratory rate will be assessed.



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 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be 18 to 50 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 >=45.0 kilograms (kg) (99 pounds [lbs]) and body mass index (BMI) within the range 18.5 to 31.0 kilograms per meter square (kg/m^2) (inclusive).
  • Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Female subjects will be included.
  • Subject must not be pregnant or breastfeeding.
  • Subject is a woman of childbearing potential (WOCBP) with intact ovarian function, as determined by medical history. Subjects must use Portia for the duration of the run-in and treatment periods.
  • WOCBP must have been on an acceptable form of contraceptive for at least 28 days prior to start of study intervention. Acceptable forms of contraception prior to study intervention include the following: Intrauterine device or intrauterine system; Combined estrogen and progestogen oral contraceptive; Contraceptive vaginal ring; Percutaneous contraceptive patches (if used, the patch must be removed during study participation); Bilateral tubal occlusion; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.; Sexual abstinence.
  • Subjects who have been on a stable regimen of an oral contraceptive for at least 3 consecutive months must be without evidence of breakthrough bleeding or spotting.
  • Subjects who have been taking oral contraceptives should continue their current regimen until check-in to the clinic for the run-in period. Subjects not currently taking an oral contraceptive are eligible, provided all other eligibility criteria are met.
  • Subjects may proceed to the treatment period provided the toxicity profile during the run-in period with Portia is acceptable in the opinion of the investigator.
  • Subjects must agree to use an additional method of contraception from the following list of contraceptive methods for the run-in period, treatment period, and for 28 days after the last dose of study intervention: Non hormonal Intrauterine device; Bilateral tubal occlusion; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.; Sexual abstinence. For the 28 days after study exit, women may resume oral contraceptives but double barrier methods (a combination of male condom with either cervical cap, diaphragm, or sponge with spermicide) must be used in addition.
  • Women of childbearing potential must have a negative highly sensitive serum pregnancy test on Day -4 and Day -1.
  • Additional requirements for pregnancy testing during and after study intervention as outlined in protocol.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.

Exclusion Criteria:

  • History of jaundice associated with taking oral contraceptives or with pregnancy.
  • History of clinically significant irregular bleeding while taking oral contraceptives.
  • History of past deep venous thrombosis, pulmonary embolism, stroke, transient ischemic attack, phlebitis, or migraine headaches with prolonged aura.
  • History of cerebrovascular or coronary artery disease.
  • History of retinal vascular lesions.
  • History of carcinoma of the breast, endometrium, or other known estrogen-dependent neoplasia.
  • 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 Healthcare/GlaxoSmithKline (GSK) 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, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.
  • Presence of hepatitis B surface antigen 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%).
  • 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, etc), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory result(s) 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 nonprescription 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 intervention and for the duration of the study (acetaminophen/paracetamol at doses of <=2 grams/day and hydrocortisone cream 1% are permitted for use any time during 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 investigational product (whichever is longer).
  • Where participation in the study would result in donation of blood or blood products in excess of 500 milliliters (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., symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, second-degree atrioventricular block Mobitz Type II, or third-degree atrioventricular block) which, in the opinion of the investigator or ViiV Healthcare/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-<50 or >100 beats per minute and QTcF->450 milliseconds.
  • 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 g of alcohol: a half-pint (equivalent to 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
  • Unable to refrain from tobacco- or nicotine-containing 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): NCT03984825


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Texas
GSK Investigational Site Recruiting
Austin, Texas, United States, 78744
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Theresa Pham         
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: NCT03984825     History of Changes
Other Study ID Numbers: 208135
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 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
ethinyl estradiol
levonorgestrel
oral contraceptive
drug-drug interaction

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
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined