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-IT
- Lead Sponsor
- GILEAD SCIENCES INCORPORATED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 86
e 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 Visit6) 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 Main Objective: To characterize the virologic efficacy of switching virologically<br>suppressed subjects on an E/C/F/TAF FDC or TDF-containing regimen to<br>B/F/TAF FDC defined by HIV-1 RNA <50 copies/mL at Week ;Secondary Objective: - To characterize the safety and tolerability of switching to B/F/TAF FDC<br>from an E/C/F/TAF FDC or TDF-containing regimen up to week 96 (week 96 included)<br>- To characterize the virologic efficacy of switching to B/F/TAF FDC<br>defined by HIV-1 RNA <50 copies/mL at Week 48, Week 72 and Week 96.;Primary end point(s): HIV-1 RNA <50 copies/mL at Week 24 - defined by the Food and Drug<br>Administration (FDA) snapshot algorithm;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Adverse events through Week 24<br>- Adverse events through Week 48<br>- HIV-1 RNA <50 copies/mL at Week 48 - defined by the Food and Drug<br>Administration (FDA) snapshot algorithm<br>-HIV-1 RNA <50 copies/mL at Week 72 - defined by the Food and Drug<br>Administration (FDA) snapshot algorithm<br>-HIV-1 RNA <50 copies/mL at Week 96 - defined by the Food and Drug<br>Administration (FDA) snapshot algorithm;Timepoint(s) of evaluation of this end point: Week 24, Week 48, Week 72 and Week 96