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
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 = 18 years 3) Currently receiving ABC/3TC plus a third antiretroviral (ARV) agent for = 6 consecutive months prior to the screening visit. For subjects with 3 or more ART regimens, a regimen history must be provided to the Sponsor for approval. 4) Documented plasma HIV-1 RNA levels 54 years of age with cessation (for = 12 months) of previously occurring menses). d) Of childbearing potential and agrees to utilize the protocol specified method of contraception or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs. e) Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing. 13) Male subjects must agree to specified highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
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) Positive Hepatitis B surface antigen (HBsAg) 6) Subjects with clinical evidence of decompensated cirrhosis (ascites, encephalopathy, variceal bleeding) 7) Females who are breastfeeding 8) Positive serum pregnancy test 9) Have an implanted defibrillator or pacemaker 10) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance 11) 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 1visit and must not be anticipated to require systemic therapy during the study. 12) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 13) 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 14) Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial 15) Known hypersensitivity to the study drug, the metabolites, or formulation excipients 16) 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 3TC, COBI, EVG, FTC, or TAF; 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 efficacy of switching to E/C/F/TAF FDC relative to continuing on a baseline regimen consisting of ABC/3TC plus a third antiretroviral agent in maintaining HIV-1 RNA < 50 copies/mL at Week 24 (using FDA snapshot algorithm) in virologically suppressed, HIV-1 infected adult subjects; Secondary Objective: - To evaluate the proportion of subjects maintaining virological response (defined as HIV-1 RNA < 50 copies/mL, FDA snapshot analysis) at Weeks 12 and 48 - To evaluate changes from baseline in CD4+ cell counts at Weeks 24 and 48 - To evaluate the safety and tolerability of the two treatment groups over 24 and 48 weeks ;Primary end point(s): Proportion of subjects with HIV-1 RNA <50 copies/mL at Week 24 as defined by the FDA snapshot algorithm;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Proportion of subjects with HIV-1 RNA <50 copies/mL at Weeks 12 and 48 as defined by the FDA snapshot algorithm 2) The change from baseline in CD4+ cell counts at Weeks 24 and 48 ; Timepoint(s) of evaluation of this end point: 1) Weeks 12 and 48 2) Weeks 24 and 48 | — |
Countries
France, Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed