Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
18 février 2020 mis à jour par: Gilead Sciences
A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
Aperçu de l'étude
Statut
Statut
Complété
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Type d'étude
Type d'étude
Interventionnel
Inscription (Réel)
Inscription
252
Phase
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New South Wales
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Darlinghurst, New South Wales, Australie, 2010
- Holdsworth House Medical Practice
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Victoria
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Melbourne, Victoria, Australie, 3004
- Clinical Research Infectious Diseases Department- Alfred Hospital
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Prahran, Victoria, Australie, 3181
- Prahran Market Clinic
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Barcelona, Espagne, 8907
- Hospital Universitari de Bellvitge
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Barcelona, Espagne, 8916
- Germans Trias i Pujol University Hospital
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Madrid, Espagne, 28046
- Hospital La Paz
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Lyon, France, 69004
- Hôpital de La Croix Rousse
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Paris, France, 75651
- GHPS Service des maladies infectieuses et tropicales pavillon Laveran unité de recherche clinique
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Jalisco
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Guadalajara, Jalisco, Mexique, 44340
- Hospital Civil de Guadalajara Dr. Juan I. Menchaca
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Utrecht, Pays-Bas, 3584 CX
- University Medical Center Utrecht
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Brighton, Royaume-Uni, BN2 1ES
- Brighton & Sussex University Hospitals NHS Trust
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London, Royaume-Uni, SE5 9RJ
- Kings college london
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London, Royaume-Uni, Sw10 9NH
- Chelsea and Westminster NHS Foundation Trust Hospital
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Manchester, Royaume-Uni, M13 0FH
- Central Manchester University Hospitals NHS Foundation Trust
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Santo Domingo, République Dominicaine, 99999
- Instituto Dominicano de Estudios Virologicos (IDEV)
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Bangkok, Thaïlande, 10400
- Faculty of Medicine Ramathibodi Hospital, Mahidol University
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Bangkok, Thaïlande, 10330
- HIV-NAT, Thai Red Cross AIDS Research Centre
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Bangkok, Thaïlande, 10700
- Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
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Khon Kaen, Thaïlande, 40002
- Srinagarind Hospital, Khon Kaen University
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Arizona
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Phoenix, Arizona, États-Unis, 85015
- Pueblo Family Physicians
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Phoenix, Arizona, États-Unis, 85006
- Maricopa Integrated Health System - McDowell Clinic
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Arkansas
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Little Rock, Arkansas, États-Unis, 72207
- Health For Life Clinic Pllc
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California
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Beverly Hills, California, États-Unis, 90211
- Pacific Oaks Medical Group
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Hayward, California, États-Unis, 94545
- Kaiser Permanente
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Long Beach, California, États-Unis, 90813
- Long Beach Education and Research Consultants
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Los Angeles, California, États-Unis, 90069
- Anthony Mills MD, Inc
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Los Angeles, California, États-Unis, 90036
- Peter J Ruane, MD, Inc
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Los Angeles, California, États-Unis, 90028
- LA Gay & Lesbian Center - Jeffrey Goodman Special Care Clinic
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Palm Springs, California, États-Unis, 92262
- Desert Medical Group Inc. dba Desert Oasis Healthcare Medical Group
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Sacramento, California, États-Unis, 95825
- Kaiser Permanente Medical Group
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San Francisco, California, États-Unis, 94109
- Metropolis Medical
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San Francisco, California, États-Unis, 94118
- Kaiser Permanente CTU San Francisco
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado
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Denver, Colorado, États-Unis, 80206
- National Jewish Health
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District of Columbia
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Washington, District of Columbia, États-Unis, 20009
- Dupont Circle Physician's Group
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Florida
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Fort Lauderdale, Florida, États-Unis, 33316
- Gary J. Richmond, MD PA
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Fort Pierce, Florida, États-Unis, 34982
- Midway Immunology and Research Center
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Orlando, Florida, États-Unis, 32806
- Idocf/Valuhealthmd
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Tampa, Florida, États-Unis, 33602
- University of South Florida
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West Palm Beach, Florida, États-Unis, 33401
- Triple O Research Institute, P.A.
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Wilton Manors, Florida, États-Unis, 33305
- Rowan Tree Medical, P.A.
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Georgia
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Decatur, Georgia, États-Unis, 30033
- Infectious Disease Specialists of Atlanta
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Macon, Georgia, États-Unis, 31210
- Mercer University
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Indiana University School of Medicine
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- Community Research Initiative of New England
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Springfield, Massachusetts, États-Unis, 01105
- The Research Institute
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Michigan
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Berkley, Michigan, États-Unis, 48210
- Be Well Medical Center, P.C.
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Health System
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55415
- Hennepin County Medical Center
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Missouri
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Kansas City, Missouri, États-Unis, 64111
- The Kansas City Care Clinic (KC Free Health Clinic)
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Saint Louis, Missouri, États-Unis, 63139
- Southampton Healthcare, Inc.
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New Jersey
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Neptune, New Jersey, États-Unis, 07754
- Jersey Shore University Medical Center
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Newark, New Jersey, États-Unis, 07102
- Saint Michael's Medical Center
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New Mexico
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Santa Fe, New Mexico, États-Unis, 87505
- Southwest CARE Center
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New York
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Albany, New York, États-Unis, 12208
- Albany Medical College
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Albany, New York, États-Unis, 12208
- Upstate Infectious Diseases Associates
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Bronx, New York, États-Unis, 10467
- Montefiore Medical Center
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Bronx, New York, États-Unis, 10461
- Jacobi Medical Center
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Manhasset, New York, États-Unis, 11030
- North Shore University Hospital/Division of Infectious Diseases
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Rochester, New York, États-Unis, 14607
- Aids Care
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Ohio
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Cincinnati, Ohio, États-Unis, 45267-0405
- University of Cincinnati
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Cleveland, Ohio, États-Unis, 44109
- MetroHealth Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of PA HIV Clinical Trials Unit
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Texas
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Bellaire, Texas, États-Unis, 77401
- St. Hope Foundation
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Dallas, Texas, États-Unis, 75246
- North Texas Infectious Diseases Consultants, PA
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Harlingen, Texas, États-Unis, 78550
- Garcias' Family Health Group
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Houston, Texas, États-Unis, 77004
- Therapeutic Concepts, PA
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Houston, Texas, États-Unis, 77098
- Gordon E. Crofoot MD, PA
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Washington
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Seattle, Washington, États-Unis, 98104
- Peter Shalit, MD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Key Inclusion Criteria:
Cohort 1 (treatment-experienced switch)
- Must not have a history of known resistance to elvitegravir (EVG), tenofovir disoproxil fumarate (TDF), or emtricitabine (FTC)
- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels (according to the local assay being used) in the 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
- Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the Cockcroft-Gault formula for creatinine clearance, using actual weight
- May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that study is complete; or currently receiving Stribild® (STB) or atazanavir (ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that study is complete.
Cohort 2 (treatment-naive)
- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
- Screening genotype report provided by Gilead Sciences must show sensitivity to EVG, FTC, and TDF
- No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis (PEP), up to 6 months prior to screening
- Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine clearance, using actual weight
All Cohorts:
All individuals must meet all of the following inclusion criteria to be eligible for participation in this study:
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- CD4+ count of ≥ 50 cells/μL
- Stable renal function: serum creatinine measurements to be taken at least once (within three months of screening)
- Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without change in medical management, for 3 months prior to baseline
- Normal electrocardiogram (ECG)
- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Females of childbearing potential must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence) from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
- Females 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
- Males must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product. A highly effective method of contraception is defined as two separate forms of contraception, one of which must be an effective barrier method, or males must be non-heterosexually active, or practice sexual abstinence
Key Exclusion Criteria:
- A new AIDS-defining condition (excluding CD4 cell count and percentage criteria) diagnosed within the 30 days prior to screening,with the exception of the first two bullet points
- Hepatitis C virus (HCV) antibody positive. Individuals who are HCV positive, but have a documented negative HCV RNA, are eligible
- Hepatitis B surface antigen (HBVsAg) positive
- Individuals receiving drug treatment for Hepatitis C, or individuals who are anticipated to receive treatment for Hepatitis C during the course of the study
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- Individuals on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone and dexamethasone)
- Individuals receiving ongoing therapy with any medications not to be used with EVG, COBI, FTC, or TAF or individuals with any known allergies to the excipients of E/C/F/TAF
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Nombre de bras
1
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
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Expérimental: E/C/F/TAF
Participants will receive E/C/F/TAF for 144 weeks.
Following Week 144, in countries where E/C/F/TAF is not available (except for the United Kingdom), participants will be given the option to continue in the study and receive E/C/F/TAF for another 48 weeks, or until the product becomes available through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever comes first.
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E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
Délai: Baseline; Week 24
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eGFR is a measurement of the kidney's ability to filter blood.
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Baseline; Week 24
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Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24
Délai: Baseline; Week 24
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eGFR is a measurement of the kidney's ability to filter blood.
The eGFR_CKD-EPI,cysC method is adjusted for age and sex.
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Baseline; Week 24
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Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24
Délai: Baseline; Week 24
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eGFR is a measurement of the kidney's ability to filter blood.
The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.
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Baseline; Week 24
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Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
Délai: Baseline; Week 2, 4, or 8; Week 24
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aGFR was directly measured using iohexol plasma clearance (CLiohexol).
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Baseline; Week 2, 4, or 8; Week 24
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Percent Change From Baseline in C-type Collagen Sequence (CTX) at Weeks 24 and 48
Délai: Baseline; Weeks 24 and 48
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CTX is a biomarker of bone turnover.
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Baseline; Weeks 24 and 48
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Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 24 and 48
Délai: Baseline; Weeks 24 and 48
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P1NP is a biomarker of bone turnover.
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Baseline; Weeks 24 and 48
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Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144
Délai: Baseline; Weeks 24, 48, 96, and 144
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Urine RBP is a renal biomarker which is used to evaluate drug-induced kidney injury.
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Baseline; Weeks 24, 48, 96, and 144
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Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144
Délai: Baseline; Weeks 24, 48, 96, and 144
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Urine beta-2-microglobulin is a renal biomarker which is used to evaluate drug-induced kidney injury.
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Baseline; Weeks 24, 48, 96, and 144
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Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities
Délai: Baseline up to Week 240 plus 30 days
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Adverse events (AEs) and graded laboratory abnormalities occurring during the E/C/F/TAF treatment period were summarized across the participant population.
A participant was counted once if they had a qualifying event.
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Baseline up to Week 240 plus 30 days
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Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Weeks 24, 48, 96, and 144
Délai: Weeks 24, 48, 96, and 144
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The percentage of participants achieving HIV-1 RNA < 50 Copies/mL at Weeks 24, 48, 96, and 144 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
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Weeks 24, 48, 96, and 144
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Pharmacokinetic (PK) Parameter: Cmax of TAF
Délai: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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Cmax is defined as the maximum concentration of drug.
Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
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Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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PK Parameter: Tmax of TAF
Délai: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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Tmax is defined as the time of Cmax.
Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
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Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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PK Parameter: Clast of TAF
Délai: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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Clast is defined as the last observable concentration of drug.
Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
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Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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PK Parameter: Tlast of TAF
Délai: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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Tlast is defined as the time of Clast.
Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
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Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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PK Parameter: λz of TAF
Délai: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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λz is defined as the terminal elimination rate constant.
Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
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Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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PK Parameter: AUCtau of TAF
Délai: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
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Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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PK Parameter: t1/2 of TAF
Délai: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
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Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study
Délai: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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TFV-DP is an active phosphorylated metabolite of tenofovir alafenamide.
AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
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Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
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Change From Baseline in the eGFR_CG at Weeks 48, 96, and 144
Délai: Baseline; Weeks 48, 96, and 144
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eGFR is a measurement of the kidney's ability to filter blood.
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Baseline; Weeks 48, 96, and 144
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Change From Baseline in eGFR_CKD-EPI,cysC at Weeks 48, 96, and 144
Délai: Baseline; Weeks 48, 96, and 144
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eGFR is a measurement of the kidney's ability to filter blood.
The eGFR_CKD-EPI,cysC method is adjusted for age and sex.
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Baseline; Weeks 48, 96, and 144
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Change From Baseline in eGFR_CKD-EPI,Creatinine at Weeks 48, 96, and 144
Délai: Baseline; Weeks 48, 96, and 144
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eGFR is a measurement of the kidney's ability to filter blood.
The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.
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Baseline; Weeks 48, 96, and 144
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Pozniak A, Arribas JR, Gathe J, Gupta SK, Post FA, Bloch M, Avihingsanon A, Crofoot G, Benson P, Lichtenstein K, Ramgopal M, Chetchotisakd P, Custodio JM, Abram ME, Wei X, Cheng A, McCallister S, SenGupta D, Fordyce MW; GS-US-292-0112 Study Team. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):530-7. doi: 10.1097/QAI.0000000000000908.
- Post FA, Tebas P, Clarke A, Cotte L, Short WR, Abram ME, Jiang S, Cheng A, Das M, Fordyce MW. Brief Report: Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Adults With Renal Impairment: 96-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):180-184. doi: 10.1097/QAI.0000000000001186.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
Début de l'étude
27 mars 2013
Achèvement primaire (Réel)
Achèvement primaire
31 juillet 2014
Achèvement de l'étude (Réel)
Achèvement de l'étude
18 juillet 2018
Dates d'inscription aux études
Première soumission
Première soumission
22 mars 2013
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
22 mars 2013
Première publication (Estimation)
Première publication
26 mars 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
2 mars 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 février 2020
Dernière vérification
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Maladies rénales
- Maladies urologiques
- Infections à VIH
- Insuffisance rénale
- Agents anti-infectieux
- Agents antiviraux
- Agents anti-VIH
- Agents antirétroviraux
- Elvitégravir, cobicistat, emtricitabine, combinaison médicamenteuse de fumarate de ténofovir disoproxil
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- GS-US-292-0112
- 2013-000516-25 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Qualified external researchers may request IPD for this study after study completion.
For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Délai de partage IPD
18 months after study completion
Critères d'accès au partage IPD
A secured external environment with username, password, and RSA code.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .