The 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 evaluate the effectiveness of switching to B/F/TAF FDC in HIV-1 infected adults aged = 65 years who are virologically suppressed (HIV-1 RNA test <50 copies/mL) currently on elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide FDC or tenofovir disoproxil fumarate containing regimens.
- 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
- EUCTR2017-003428-61-BE
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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 = 65 years
3) Currently receiving an ARV regimen of E/C/F/TAF FDC (or FTC/TDF + 3rd agent if currently or previously participated in GS-US-292-1826) for = 3 months
4) Documented plasma HIV-1 RNA < 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in GS-US-292-1826) for the last 2 visits 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)
a) Unconfirmed virologic elevations of = 50 copies/mL but < 400 copies/mL (transient detectable viremia, or blip”) in the past are acceptable.
b) If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests after < 50 copies/mL has been achieved.
5) Plasma HIV-1 RNA levels < 50 copies/mL at Screening Visit
6) Have no documented or suspected resistance to FTC, TFV, or BIC including, but not limited, to the reverse transcriptase resistance mutations K65R and M184V/I
7) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
8) Adequate renal function: eGFR = 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
9) Male subjects who are fertile and engage in heterosexual intercourse with women who are of child-bearing potential must agree to use protocol specified method(s) of contraception
10) Male subjects must agree to refrain from sperm donation from first study drug dose until after the end of relevant systemic exposure
11) Life expectancy >1 year
12) Hepatic transaminases (AST and ALT) = 5 upper limit of normal (ULN)
13) Total bilirubin = 1.5X ULN or normal direct bilirubin
14) Adequate hematologic function (absolute neutrophil count = 750/mm3 (= 0.75 GI/L); platelets = 50,000/mm3 (= 50 GI/L); hemoglobin = 8.5 g/dL (= 85 g/L))
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
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
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 (e.g. prednisone doses > 10 mg daily or equivalent) 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) Malignancy within 5 years of screening other than cutaneous Kaposi’s sarcoma, completely resected non-melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus
(AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed.
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 Medical Monitor
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 tablets, their metabolites, or formulation excipient
10) Subjects receiving ongoing therapy with any of the medications listed in the protocol, including drugs not to be used with BIC, FTC, and TAF
11) Acute hepatitis in the 30 days prior to study entry
12) Active tuberculosis infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): HIV-1 RNA <50 copies/mL at Week 24 - defined by the Food and Drug Administration (FDA) snapshot algorithm;Timepoint(s) of evaluation of this end point: Week 24;Main Objective: To characterize the virologic efficacy of switching virologically suppressed subjects on an E/C/F/TAF FDC or TDF-containing regimen to B/F/TAF FDC defined by HIV-1 RNA <50 copies/mL at Week 24;Secondary Objective: - To characterize the safety and tolerability of switching to B/F/TAF FDC from an E/C/F/TAF FDC or TDF-containing regimen through Week 96.<br>- To characterize the virologic efficacy of switching to B/F/TAF FDC defined by HIV-1 RNA <50 copies/mL at Week 48, Week 72 and Week 96.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Adverse events through Week 24<br>- Adverse events through Week 48<br>- Adverse events through Week 72<br>- Adverse events through Week 96<br><br>- HIV-1 RNA <50 copies/mL at Week 48 - defined by the Food and Drug Administration (FDA) snapshot algorithm<br>- HIV-1 RNA <50 copies/mL at Week 72 - defined by the Food and Drug Administration (FDA) snapshot algorithm<br>- HIV-1 RNA <50 copies/mL at Week 96 - defined by the Food and Drug Administration (FDA) snapshot algorithm;Timepoint(s) of evaluation of this end point: Week 24, Week 48, Week 72 and Week 96.