Status:
COMPLETED
Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse transcriptase inhibito...
Eligibility Criteria
Inclusion
- HIV-1 infected subjects \>=18 years of age.
- A female subject may be eligible to enter and participate in the study if she:
- is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and \>=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, is of child-bearing potential, with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the protocol-defined methods of contraception to avoid pregnancy throughout the study and for at least 2 weeks after discontinuation of all study medication.
- HIV-1 infection as documented by HIV-1 RNA \>=400 c/mL at Screening.
- Subject has been on a first-line treatment regimen consisting of an NNRTI plus two NRTIs for at least 6 months and is currently experiencing virologic failure to this first-line regimen defined as two consecutive (\>=7 days apart) HIV-1 RNA results of \>=400 c/mL.
- Subjects must receive at least one fully active agent within the dual-NRTI background regimen for second line treatment. Fully active is defined by the Screening genotypic resistance report of the central laboratory (or a laboratory contracted by the central laboratory) showing no evidence of full or of partial resistance for a given NRTI which will be taken on study.
- Subject is PI-naïve and Integrase inhibitor (INI)-naïve, defined as no prior or current exposure to any PI or INI.
- Subject or the subject's legal representative is willing and able to understand and provide signed and dated written informed consent prior to screening.
Exclusion
- Women who are breastfeeding.
- Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease Exceptions include cutaneous Kaposi's sarcoma not requiring systemic therapy and historic or current CD4+ cell levels \<200 cells per cubic millimeter
- Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Anticipated need for hepatitis C virus (HCV) therapy during the Randomized Phase of the study.
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject.
- Subjects who in the investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
- Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, systemically administered immunomodulators.
- Treatment with any agent, other than licensed ART as allowed above with documented activity against HIV-1 in vitro/vivo within 28 days of first dose of IP. The exception is use of entecavir, in appropriate clinical situations, for treatment of hepatitis B \[e.g. prior intolerance to Tenofovir (TDF), viral resistance to lamivudine (3TC) / Emtricitabine (FTC)\] after discussion and agreement between the investigator and the medical monitor.
- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP.
- Any evidence of primary viral resistance to PIs or INIs based on the presence of any major resistance-associated mutation.
- The subject's virus does not yield results using genotype at Screening (assay data is essential for eligibility determination).
- Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 triglycerides. A single repeat test is allowed during the Screening period to verify a result.
- Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound.
- Alanine aminotransferase (ALT) \>=5 times the upper limit of normal (ULN) or ALT \>=3xULN and bilirubin \>=1.5xULN (with \>35% direct bilirubin)
Key Trial Info
Start Date :
December 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2022
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT02227238
Start Date
December 11 2014
End Date
February 14 2022
Last Update
March 13 2023
Active Locations (59)
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1
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1405CKC
2
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1202ABB
3
GSK Investigational Site
Rosario, Santa Fe Province, Argentina, 2000
4
GSK Investigational Site
Buenos Aires, Argentina, 1141