Treatment of Human Immunodeficiency Virus (HIV) infection in patients with raltegravir (RAL) or elvitegravir (ELV) resistance who have limited treatment options. MedDRA version: 14.1 Level: LLT Classification code 10020194 Term: HIV-2 infection System Organ Class: 100000004862 MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Dolutegravir
Pharmaceutical Form: Tablet
INN or Proposed INN: Dolutegravir
CAS Number: 1051375-19-9
Current Sponsor code: GSK1349572
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
ViiV Healthcare UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged =12 years weighing >40kg NOTE: all female patients of child-bearing potential should use every precaution to prevent pregnancy. Contraception guidelines include: • Complete abstinence from intercourse from 2 weeks prior to administration of DTG, throughout receipt of DTG, and for at least 2 weeks after discontinuation of DTG; • Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); • Approved hormonal contraception; • Any intrauterine device (IUD) with published data showing that the expected failure rate is =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Deviations from exclusion criteria are not allowed because they can potentially jeopardize patient safety. Therefore, adherence to the criteria as specified in the protocol is essential. Patients meeting any of the following criteria must not be enrolled in the program: 1. Patient has estimated creatinine clearance (CrCl) 5 times the upper limit of normal (ULN) within 1 month of treatment initiation and/or at last ALT determination. 5. ALT >3 times ULN and total bilirubin >1.5 times ULN (with >35% direct bilirubin within 1 month of treatment initiation) and/or at last ALT and bilirubin determinations. 6. Evidence for severe hepatic impairment (Child-Pugh class C). 7. Patients who are eligible for, and have access to, an actively enrolling DTG Phase III/b clinical trial. 8. Any condition (including but not limited to alcohol and drug use) or any active clinically significant disease or findings during Screening of medical history or physical examination, which, in the opinion of the Investigator would interfere with patient safety or compliance. 9. Patient requires or is anticipated to require any of the prohibited concomitant therapy as listed in Section 5.6.2. • French patients recruited at sites in France will be excluded if the patient has participated in any study using an investigational drug during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to Screening for the study, or the patient will participate simultaneously in another clinical trial. NOTE: Patients should not be considered for the EAP if they are eligible and able to participate in any of the clinical treatment trials of DTG in treatment-experienced patients (protocols ING111762, ING112961 or ING112574). Please refer to any national or local requirements for participation in EAPs. In that instance (assuming consent is obtained), the patient should preferentially be enrolled into the ongoing clinical trial to allow detailed data collection. Physicians with patients who do not fit all criteria cited above yet have a significant unmet medical need may appeal to the ViiV Safety and Labelling Committee in order to secure access to DTG under this program. Notwithstanding these minimum inclusion and exclusion criteria, Investigators must also follow country specific guidelines where they exist when making decisions about patients who are eligible for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide access in an open-label protocol program to patients who have documented RAL or ELV resistance, who have limited treatment options and who require DTG to construct a viable antiretroviral (ARV) regimen for therapy. Eligible patients are those who are unable to participate in the Phase III/b DTG studies. ;Secondary Objective: The secondary objective is to assess any serious adverse events (SAEs) and any adverse events (AEs) that lead to the discontinuation of DTG 50 mg twice daily (BID).;Primary end point(s): This is an open-label, expanded access study. No formal hypotheses testing will be performed. Data will provide only descriptive information on safety.;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trials Helpdesk
GlaxoSmithKline Research and Development Ltd
Outcome results
None listed