EUCTR2016-000459-28-IT
Active, not recruiting
Phase 1
A Phase III, randomised,double-blind, multicentre, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir pluslamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected treatment-na¿ve adults - Gemini 2
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Human Immunodeficiency Virus-1 infection
- Sponsor
- VIIV HEALTHCARE UK LIMITED
- Enrollment
- 722
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible subjects must:
- •be able to understand and comply with protocol requirements,
- •instructions, and restrictions;
- •be likely to complete the study as planned;
- •be considered appropriate candidates for participation in an
- •investigative clinical trial with oral medication (e.g. no active substance abuse, acute major organ disease, or planned long\-term work assignments out of the country). A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1\. HIV\-1 infected adults 18 years of age, (or older, if required by local
- •regulations), at the time of signing the informed consent. 2\.Screening plasma HIV\-1 RNA of 1000 c/mL to \<\= 100,000 c/mL. If an
- •independent review of accumulated data from other clinical trials
- •investigating the DTG plus 3TC dual regimen is supportive of the DTG
- •plus 3TC treatment regimen, enrolment will be opened to subjects with
Exclusion Criteria
- •A subject will not be eligible for inclusion in this study if any of the
- •following criteria apply:
- •1\.Women who are breastfeeding or plan to become pregnant or breastfeed during the study; 2\.Any evidence of an active Center for Disease Control and Prevention (CDC) Stage 3 disease \[CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm3\. 3\.Subjects with severe hepatic impairment (Class C) as determined by Child\-Pugh classification; 4\.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); 5\.Evidence of HBV infection based on the results of testing at Screening for HBV surface antigen (HBsAg), HBV core antibody (anti\-HBc), HBV surface antibody (anti\-HBs or HBsAb), and HBV DNA as follows: •Subjects positive for HBsAg are excluded;
- •Subjects negative for anti\-HBs but positive for anti\-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
- •NOTE: Subjects positive for anti\-HBc (negative HBsAg status) and positive for anti\-HBs (past and/or current evidence) are immune to HBV and are not excluded. 6\.Anticipated need for any HCV therapy during the first 48 weeks of the
- •study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug:drug interactions with study treatment throughout the entire study period; 7\.Untreated syphilis infection (positive rapid plasma reagin \[RPR] at
- •Screening without clear documentation of treatment). Subjects who are at least 14 days post completed treatment are eligible.
- •8\.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class; 9\.Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Study Medical Monitor for inclusion of the subject. 10\.Subjects who in the investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behaviour and/or suicidal ideation may be considered as evidence of serious suicide risk.
- •EXCLUSIONARY TREATMENTS PRIOR TO SCREENING OR DAY 1 11\.Treatment with an HIV\-1 immunotherapeutic vaccine within 90 days of Screening; 12\.Treatment with any of the following agents within 28 days of Screening i.radiation therapy, ii.cytotoxic chemotherapeutic agents, iii.any systemic immune suppressant; 13\.Treatment with any agent, except recognised ART as allowed above (inclusion criterion 3\.), with documented activity against HIV\-1 in vitro within 28 days of first dose of study treatment; 14\.Exposure to an experimental drug or experimental vaccine within either 28 days, 5 halflives 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 study
Outcomes
Primary Outcomes
Not specified
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Unknown
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