Human immunodeficiency virus (HIV) MedDRA version: 20.1 Level: LLT Classification code 10020194 Term: HIV-2 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Triumeq® 50 mg/600 mg/300 mg comprimidos revestidos por película dolutegravir/abacavir/lamivudina
Product Name: Not applicable
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN:
Sponsors
Blueclinical, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to understand and willing to comply with all the requirements of the study, as confirmed by giving voluntary written informed consent for participation. 2. Male or female gender. 3. Age = 18 years on the day of signing the informed consent. 4. HIV-2 positive as determined by a positive result in the respective assay. 5. CD4 count =500 cells/mm3 (in case of undetectable baseline HIV-2 viral load); and/or classified as B- or C-stage, by the HIV disease staging and classification system of Centers for Disease Control and Prevention (CDC); and/or have detectable viral load irrespective of CD4 count; and/or have other medical conditions / co-morbidities in which treatment is considered, according to European AIDS Clinical Society (EACS) and national guidelines. 6. Naïve to ART including investigational antiretroviral agents1. 7. Considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study (i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study), in the opinion of the investigator. 8. If woman or man with reproductive potential, agrees to adopt one of the following effective contraceptive methods throughout the study: a) True abstinence, if this is in line with the preferred and usual lifestyle of the subject [Period abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal method, use of post-ovulation methods) and withdrawal are not acceptable methods of contraception]. b) Use of an acceptable method of birth control throughout the study (either by subject or subject’s partner) from 30 days prior to the first dose of the study medication and until the last dose of study medication and completion of the Follow-up visit. The acceptable methods of birth control in this study are: - Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject). - Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). - Intrauterine device (IUD), if approved by the Investigator. - Intrauterine hormone-releasing system. - Bilateral tubal occlusion. - Vasectomized partner, who has received medical assessment of the surgical success. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. History or presence of allergy to the study drugs or their components. 2. HIV-1 infection or HIV-1/HIV-2 dual infection. 3. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate. 4. Documented or known resistance to DTG and/or NRTIs. 5. Treatment with systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study. NOTE: Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed. “Short courses” mean a use of corticosteroids for less than 7 days. 6. Requiring or is anticipated to require any of the prohibited medications while in the study (dofetilide, inducers of CYP3A4, including phenobarbital, phenytoin, carbamazepine and rifampicin). NOTE: Subjects must discontinue phenobarbital, phenytoin, carbamazepine, and rifampicin at least 14 days prior to the treatment phase of the study. 7. Current (active) diagnosis of tuberculosis. 8. Alanine aminotransferase (ALT) =5 times the upper limit of normal (ULN), or ALT =3xULN and bilirubin =1.5xULN (with >35% direct bilirubin). 9. Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification3. 10. If subject eligible to receive Tivicay®: Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 11. Estimated creatinine clearance <50 mL/min at time of screening, based on Cockcroft-Gault equation4. 12. Current (active) diagnosis of acute hepatitis due to any cause. NOTE: Subjects with chronic hepatitis B and C may enter the study as long as they fulfil all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function (significant impairment of hepatic synthetic function is defined as a serum albumin <2.8 g/dL in the absence of another explanation for the abnormal laboratory value) at the time of enrollment. 13. Under treatment for a viral infection other than HIV-2, such as hepatitis B, with an agent that may be active against HIV-2, including but not limited to 3TC, TDF or entecavir, unless the treatment with these agents occurred prior to the diagnosis of HIV. 14. Anticipated need for Hepatitis C virus (HCV) therapy with interferon and/or ribavirin during the study. 15. Positive HLA-B*5701 allele screening assessment and is also not eligible for treatment with the other acceptable NRTIs (TDF/FTC). 16. Significant suicidality risk, according to the investigator’s judgment. NOTE: Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk. 17. Participation in a study with an investigational compound/device within 30 days of signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study. 18. If woman, she is pregnant, breastfeeding, or expecting to conceive at any time during the study. 19. If woman, she is expecting to donate eggs at any time during the study. 20. If man, expecting to d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): <40 copies/mL and/or by the change from baseline in CD4 cell count and in CD4/CD8 ratio ;Timepoint(s) of evaluation of this end point: Week 48;Main Objective: The primary objective of this study is to evaluate the efficacy of DTG in combination with two NRTIs [ABC/3TC or TDF/FTC] in the treatment of HIV-2 treatment-naïve subjects, as measured by the proportion of subjects achieving a plasma viral load of <40 copies/mL and/or by the change from baseline in CD4 cell count and in CD4/CD8 ratio at Week 48.;Secondary Objective: The secondary objectives of this study are: - To evaluate the study treatment immunological effect, as measured by the change from baseline in CD4 cell count and the CD4/CD8 ratio at Week 48. - To evaluate the study treatment safety and tolerability, as assessed by review of the accumulated safety data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - change from baseline in CD4 cell count and the CD4/CD8 ratio - vital signs, adverse events, liver event ;Timepoint(s) of evaluation of this end point: - All studies visits | — |
Countries
Portugal
Contacts
Public ContactClinical Trials Information
Blueclinical, Ltd.
Outcome results
None listed