Human Immunodeficiency Virus (HIV-1) Infection MedDRA version: 19.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Genvoya
Product Code: E/C/F/TAF 150mg/150mg/200mg/10mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Elvitegravir
CAS Number: 697761-98-1
Other descriptive name: ELVITEGRAVI
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2) Age = 60 years 3) Currently receiving a TDF and FTC or 3TC-containing 'backbone' (maximum 2 NRTIs) regimen plus a third agent for = 6 consecutive months prior to screening visit. For subjects with 3 or more ART regimens, a regimen history must be provided for approval by the Sponsor. 4) Documented plasma HIV-1 RNA levels =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1) Previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time) if the current regimen contains a PI/r 2) Subjects will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV). 3) A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4+ cell count and/or percentage criteria) 4) Hepatitis C virus that would require therapy during the study 5) Subjects with clinical evidence of decompensated cirrhosis (ascites, encephalopathy, variceal bleeding) 6) Women of childbearing potential 7) Subjects receiving ongoing treatment for bone disease (eg, osteoporosis), including bisphosphonates, denosumab, and strontium ranelate 8) Have an implanted defibrillator or pacemaker 9) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance 10) A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 visit and must not be anticipated to require systemic therapy during the study 11) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit 12) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements 13) Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial 14) Known hypersensitivity to the study drug, the metabolites, or formulation excipients 15) Subjects receiving ongoing therapy with any of the medications in Table 4-2 of the protocol, including drugs not to be used due to the potential for interaction with EVG, COBI, FTC, TAF, or 3TC; or subjects with any known allergies to the excipients of E/C/F/TAF FDC tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the safety of E/C/F/TAF relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected subjects aged = 60 years;Secondary Objective: - To evaluate spine and hip BMD at Week 24 - To evaluate maintenance of HIV-1 RNA suppression < 50 copies/mL between regimens at Weeks 24 and 48 - To evaluate the safety and tolerability of the two treatment groups through Week 48;Primary end point(s): Percent change from Baseline to Week 48 in spine and hip BMD;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Percent change from baseline to Week 24 in spine and hip BMD 2) Proportion of subjects with HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as defined by the Food and Drug Administration (FDA) snapshot algorithm 3) Change from baseline in CD4+ cell count at Weeks 24 and 48;Timepoint(s) of evaluation of this end point: 1) Week 24 2) & 3) Weeks 24 and 48 | — |
Countries
Belgium, Spain, United Kingdom
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed