Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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23 July 2018 |
Main ID: |
EUCTR2015-002713-30-GB |
Date of registration:
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11/11/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis
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Scientific title:
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A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis |
Date of first enrolment:
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05/04/2016 |
Target sample size:
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55 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002713-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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France
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Germany
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Puerto Rico
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials Mailbox
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Address:
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Flowers Building, Granta Park
CB21 6GT
Abington, Cambridge
United Kingdom |
Telephone:
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+441223897284 |
Email:
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clinical.trials@gilead.com |
Affiliation:
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Gilead Sciences International Ltd. |
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Name:
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Clinical Trials Mailbox
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Address:
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Flowers Building, Granta Park
CB21 6GT
Abington, Cambridge
United Kingdom |
Telephone:
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+441223897284 |
Email:
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clinical.trials@gilead.com |
Affiliation:
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Gilead Sciences International Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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 screening procedures;
2) Age = 18 years;
3) Currently receiving a stable ARV regimen for = 6 consecutive months prior to screening;
4) Documented plasma HIV-1 RNA concentrations < 50 copies/mL for at least 6 months preceding the screening visit measured at least twice using the same assay) and have HIV-1 RNA < 50 copies/mL at screening; a) In the preceding 6 months prior to screening, one episode of “blip” (HIV-1 RNA = 50 copies/mL and < 400 copies/mL) is acceptable, only if HIV-1 RNA is < 50 copies/mL immediately before and after the blip. b) To determine virologic suppression in the preceding 6 months prior to screening, the lower limit of quantification (LLOQ) by the local HIV-1 RNA assay may be used, only if its LLOQ is greater than 50 copies/mL (e.g. LLOQ of 75 copies/mL);
5 )No documented history of HIV-1 resistance to EVG, FTC, 3TC or TFV and no history of switching off EVG, FTC, 3TC or TFV due to concern for resistance;
6) CD4+ T cell count of = 200 cells/µL;
7) ESRD with eGFR < 15 mL/min by Cockcroft-Gault formula for creatinine clearance;
8) On chronic HD for = 6 months prior to screening;
9) Hepatic transaminases (AST and ALT) = 5 × upper limit of normal (ULN);
10) Chronic Hepatitis C (HCV) infection allowed if liver function is stable (see above for criteria);
11) Adequate hematologic function (absolute neutrophil count = 1,000/mm3; platelets = 50,000/mm3; hemoglobin = 8.5 g/dL);
12) Serum amylase = 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is = 5 × ULN);
13) A female subject is eligible to enter the study if it is confirmed that she is: a) Not pregnant confirmed by a negative serum pregnancy test (unless permanently sterile or greater than two years post-menopausal); b) Of non-child bearing 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. c) Of childbearing potential and agrees to utilize the protocol specified method of contraception or be non-heterosexually active or practice abstinence from screening throughout the duration of the study treatment and for 30 days following study drug discontinuation; d) Female subjects who utilize hormonal contraception as one of the birth control methods must have used the same method for at least three months prior to the study dosing.
14) Male subjects must agree to use protocol specified method(s) of contraception from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs.
15) Male subjects must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.
16) Lactating females must agree to discontinue nursing before the study drug is administered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study :
1) Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.);
2) Hepatitis B surface antigen (HBsAg) positive;
3) Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening;
4) Treatment with radiation, cytotoxic chemotherapeutic agents, or any immunomodulator within 30 days of screening;
5) Any other clinical history, condition, or test result that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements;
6) Administration of other investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial, including observational trials, without prior approval from the sponsor is prohibited while participating in this trial.
7) History or presence of allergy or intolerance to the study drugs or their components;
8) A new AIDS-defining condition (excluding CD4+ T cell count and percentage criteria) diagnosed within the 30 days prior to screening, with the exception of oropharyngeal candidiasis;
9) Have an implanted defibrillator or pacemaker;
10) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance;
11) 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 carcinoma;
12) Received solid organ or bone marrow transplant;
13) Significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures;
14) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1;
15) Systemic chemotherapeutic agents, systemic corticosteroids (except short-term use of prednisone as a steroid burst [ = 1 week of use]), immunosuppressant, or immunomodulating agents;
16) Subjects receiving ongoing therapy with any of the protocol listed medications, including drugs not to be used with EVG, COBI, FTC, TAF:
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Human Immunodeficiency Virus (HIV-1) Infection in Subjects on Chronic Hemodialysis MedDRA version: 20.1
Level: LLT
Classification code 10068341
Term: HIV-1 infection
System Organ Class: 100000004862
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Intervention(s)
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Product Name: elvitegravir/cobicistat/ emtricitabine/ tenofovir alafenamide Product Code: E/C/F/TAF Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tenofovir alafenamide CAS Number: 379270-37-8 Other descriptive name: TENOFOVIR ALAFENAMIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- INN or Proposed INN: COBICISTAT CAS Number: 1004316-88-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- INN or Proposed INN: Elvitegravir CAS Number: 697761-98-1 Other descriptive name: ELVITEGRAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- INN or Proposed INN: EMTRICITABINE CAS Number: 143491-57-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
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Primary Outcome(s)
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Primary end point(s): To evaluate the safety and tolerability of E/C/F/TAF FDC in HIV-1 infected adults with ESRD on chronic HD
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Timepoint(s) of evaluation of this end point: Week 48
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Main Objective: To evaluate the safety and tolerability of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF; E/C/F/TAF) fixed dose combination (FDC) in HIV-1 infected adults with end stage renal disease (ESRD) on chronic hemodialysis (HD) at Week 48
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Secondary Objective: - To evaluate the safety and tolerability of the EVG/COBI/FTC/TAF (E/C/F/TAF FDC) in HIV-1 infected adults with ESRD on chronic HD at week 96 - To evaluate the proportion of subjects achieving virologic response (defined as HIV-1 RNA < 50 copies/mL, Snapshot analysis) at Weeks 24, 48 and 96 - To evaluate plasma pharmacokinetics (PK) of EVG, COBI, FTC, TAF and TFV in HIV-1 infected patients with ESRD on chronic HD
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Secondary Outcome(s)
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Secondary end point(s): 1) To evaluate the proportion of subjects achieving virologic response (defined as HIV-1 RNA < 50 copies/mL, Snapshot analysis);
2) To evaluate plasma pharmacokinetics (PK) of EVG, COBI, FTC, TAF and TFV in HIV-1 infected patients with ESRD on HD
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Timepoint(s) of evaluation of this end point: 1) Weeks 24, 48 and 96
2) at or between Week 4 or Week 12
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Secondary ID(s)
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GS-US-292-1825
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Source(s) of Monetary Support
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Gilead Sciences, Inc.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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