Human Immunodeficiency Virus (HIV-1) Infection MedDRA version: 16.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Emtricitabine 200 mg/Tenofovir Alafenamide 25 mg
Product Code: F/TAF
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EMTRICITABINE
CAS Number: 143491-57-0
Other descriptive
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 antiretroviral regimen containing FTC/TDF in combination with one third agent for = 6 consecutive months prior to Screening. Refer to Table 3 in the protocol for allowed third agents of the pre-existing regimen. 4. Plasma HIV-1 RNA levels 5 × ULN will remain eligible if serum lipase is = 5 × ULN) 11. 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). Female subjects who have stopped menstruating for = 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range, or c. Of childbearing potential and agrees to utilize highly effective contraception methods 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. 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. 12. 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. a. 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 590 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria) 2. Hepatitis C virus (HCV) antibody positive and HCV RNA detectable 3. Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.) 4. Females who are breastfeeding 5. Positive serum pregnancy test 6. Have an implanted defibrillator or pacemaker 7. Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance 8. 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 9. Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit 10. 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 11. Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial 12. Subjects receiving ongoing therapy with any of the medications specified on protocol p.36, including drugs not to be used with FTC, TAF, TDF or other antiretroviral third agents (refer to the individual agents Prescribing Information); or subjects with any known allergies to the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of switching FTC/TDF to F/TAF versus maintaining FTC/TDF in HIV-1 positive subjects who are virologically suppressed on regimens containing FTC/TDF as determined by the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 48.;Secondary Objective: - To evaluate the bone safety of two regimens as determined by the percentage change from baseline in hip and spine bone mineral density at Week 48 - To evaluate the efficacy, safety, and tolerability of two regimens through Week 48 and Week 96 - To evaluate the pharmacokinetics of TAF and tenofovir;Primary end point(s): The primary efficacy endpoint is the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis.;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoints include: - The percent change from baseline in hip BMD at Week 48 -The percent change from baseline in spine BMD at Week 48 Other secondary endpoints include: - The proportion of subjects with HIV-1 RNA < 50 copies/mL at Weeks 96 as defined by the FDA snapshot analysis - The proportion of subjects with HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 as defined by the FDA snapshot analysis - The change from baseline in CD4+ cell count at Weeks 48 and 96 - The percent change from baseline in hip and spine BMD at Week 96;Timepoint(s) of evaluation of this end point: Week 48 and Week 96 | — |
Countries
Belgium, Canada, France, Italy, Puerto Rico, United Kingdom, United States
Contacts
Public ContactMedical Monitor
Gilead Sciences, Inc.
Outcome results
None listed