This study will test an experimental drug called B/F/TAF (bictegravir/emtricitabine/tenofovir alafenamide) fixed dose combination (FDC) for the treatment of HIV-1 infection. The purpose of this study is to test the effectiveness of switching to B/F/TAF FDC versus continuing on DTG and F/TAF in HIV-1 infected adults who are virologically suppressed (HIV-1 RNA test <50 copies/mL)
- Conditions
- Human Immunodeficiency Virus (HIV-1) InfectionMedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-000308-17-AT
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 520
Subjects must meet all of the following inclusion criteria to be eligible for participation in this
study.
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 an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods:
a) = 6 months (if there is documented or suspected NRTI resistance prior to the screening visit),
b) = 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit)
4) Documented plasma HIV-1 RNA < 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of = 6 or = 3 months, as applicable) preceding the Screening Visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is = 50 copies/mL)
5) Plasma HIV-1 RNA levels < 50 copies/mL at Screening Visit
6) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
7) Adequate renal function
8) No documented resistance to INSTIs or confirmed virologic failure (2 consecutive HIV-1 RNA = 50 copies/mL after achieving < 50 copies/mL while on an INSTI-containing regimen)
9) Eligible subjects with the following historical ARV resistance are permitted to enroll:
- Any NRTI resistance mutations
- Any non-nucleoside reverse transcriptase mutations
- Any protease inhibitor mutations
- Subjects with resistance to 2 or more classes of antiretrovirals must be reviewed by the Gilead Medical Monitor to confirm eligibility
10) Hepatic transaminases (AST and ALT) = 5 x upper limit of normal (ULN)
11) Total bilirubin = 1.5 mg/dL (= 26 umol/L), or normal direct bilirubin
12) Adequate hematologic function
13) Serum amylase = 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is = 5 × ULN)
14) Male subjects who are fertile and females subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
15) Male subjects must agree to refrain from sperm donation from first study drug dose and throughout the study period
16) Life expectancy = 1 year
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 468
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to Appendix 5)
2) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
3) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during
the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
4) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
5) A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous
squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study
6) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
7) Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
8) 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 the dosing requirements
9) Known hypersensitivity to B/F/TAF FDC or DTG+F/TAF FDC tablets, their metabolites, or formulation excipient
10) Females who are pregnant (as confirmed by positive serum pregnancy test)
11) Females who are breastfeeding
12) Subjects receiving ongoing therapy with any of the medications listed in the protocol, including drugs not to be used with BIC, FTC, TAF, and DTG
13) Acute hepatitis in the 30 days prior to randomization
14) Active tuberculosis infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method