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
Product Name: Emtricitabine/Rilpivirine/Tenofovir Alafenamide 200 mg/25 mg/25 mg film coated tablets
Product Code: FTC/RPV/TAF
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EMTRICITABIN
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 FTC/RPV/TDF FDC for = 6 consecutive months preceding the Screening visit 4. Documented plasma HIV-1 RNA levels 50 copies/mL) for = 6 months preceding the Screening visit. After reaching HIV-1 RNA 5 × ULN will remain eligible if serum lipase is = 5 × ULN) 11. Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant) 12. Adequate renal function: Estimated glomerular filtration rate ? 50 mL/min (1.17 mL/sec) according to the Cockcroft-Gault formula 13. A female subject is eligible to enter the study if it is confirmed that she is: a) Not pregnant or nursing b) Of non-childbearing potential (i.e., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 54 years of age with cessation (for = 12 months) of previously occurring menses), or c) Of childbearing potential and agrees to utilize highly effective protocol-specified contraceptive method or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last study drug dose d) 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 14. Male subjects must agree to utilize a 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 15. Male subjects must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose 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 495 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1. Hepatitis B surface antigen (HBsAg) positive 2. Hepatitis C antibody positive with detectable HCV RNA (subjects who have HCV antibody but no detectable HCV RNA are eligible to enroll) 3. Subjects experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.) 4. Females who are breastfeeding 5. Positive serum pregnancy test 6. Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance 7. 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 Baseline/Day 1 and must not be anticipated to require systemic therapy during the study 8. Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1 9. 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 10. Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial 11. Subjects receiving ongoing therapy with any of the specified medications in the protocol, including drugs not to be used with FTC, RPV and/or TAF (refer to the individual agents Prescribing Information); or subjects with any known allergies to the excipients of FTC/RPV/TAF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the non-inferiority of switching to the FTC/RPV/TAF FDC as compared to continuing FTC/RPV/TDF FDC in virologically suppressed HIV-1 infected subjects as determined by maintaining HIV-1 RNA < 50 copies/mL at Week 48 (FDA Snapshot Algorithm);Secondary Objective: To determine the safety of the two treatment arms as determined by the percent change from baseline in hip and spine bone mineral density as assessed by dual energy X-ray absorptiometry (DXA) at Week 48 and 96 in a subset of subjects To evaluate the safety and tolerability of the two treatment arms through Week 48 To evaluate the efficacy, safety and tolerability of the two treatment arms though Week 96;Primary end point(s): The primary analysis will consist of a non-inferiority evaluation of switching to FTC/RPV/TAF FDC versus continuing FTC/RPV/TDF FDC, with respect to the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 48 after the start of treatment in this study (as defined by the FDA snapshot algorithm).;Timepoint(s) of evaluation of this end point: 48 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of subjects with HIV-1 RNA = 50 copies/mL at Weeks 48 and 96, and the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 96, as defined by the US FDA-defined snapshot algorithm. The comparison of FTC/RPV/TAF versus FTC/RPV/TDF, with respect to the percent change from baseline in hip and spine bone mineral density (BMD) in DXA substudy will be conducted using Analysis of Variance (ANOVA) model, including treatment group as a fixed effect in the model. The AE and clinical laboratory data will be summarized using descriptive statistics.;Timepoint(s) of evaluation of this end point: 48 and 96 weeks | — |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactMedical monitor
Gilead Sciences, Inc.
Outcome results
None listed