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Phase 3b Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV 1 Infected Patients

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acquired Immunodeficiency Syndrome; HIV Infections

Intervention: Stribild (Drug); RTV (Drug); FTC/TDF (Drug); PI (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Thai Nguyen, MD, Study Director, Affiliation: Gilead Sciences

Summary

This study will evaluate the non-inferiority of Stribild (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate [EVG/COBI/FTC/TDF]) single-tablet regimen relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) plus truvada (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Clinical Details

Official title: A Phase 3b Randomized, Open-Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

Secondary outcome: Change From Baseline in CD4+ Cell Count at Week 48

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ability to understand and sign a written informed consent form

- Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus

FTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit

- Be on the first or second antiretroviral drug regimen documented undetectable plasma

HIV 1 RNA levels for ≥ 6 months preceding the screening visit

- No previous use of any approved or experimental integrase strand transfer inhibitor

(INSTI) for any length of time

- Documented historical genotype prior to starting initial antiretroviral therapy

showing no known resistance to TDF or FTC

- HIV RNA < 50 copies/mL

- Normal ECG

- Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)

- Total bilirubin ≤ 1. 5 mg/dL, or normal direct bilirubin

- Adequate hematologic function

- Serum amylase ≤ 5 × ULN

- Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault

formula

- Females of childbearing potential must agree to utilize highly effective

contraception methods, or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug

- Female subjects 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

- Male subjects must agree to utilize a highly effective method of contraception during

heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product, or must be non-heterosexually active, or practice sexual abstinence Exclusion Criteria:

- A new AIDS-defining condition diagnosed within the 30 days prior to screening

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Receiving drug treatment for hepatitis C, or subjects who are anticipated to receive

treatment for hepatitis C during the course of the study

- Experiencing decompensated cirrhosis

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance abuse that would interfere with compliance

- A history of malignancy within the past 5 years or ongoing malignancy other than

cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma

- Active, serious infections requiring parenteral antibiotic or antifungal therapy

within 30 days prior to Baseline, except for intramuscular penicillin for the treatment of syphilis

- 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

- Subjects receiving ongoing therapy with any of the medications, including drugs not

to be used with EVG, COBI, FTC, TDF or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF tablets, or Truvada® tablets.

- No anticipated need to initiate drugs during the study that are contraindicated

- Receiving other investigational drugs

- Participation in any other clinical trial

- Any other clinical condition or prior therapy that would make the subject unsuitable

for the study or unable to comply with the dosing requirements

Locations and Contacts

Innsbruck Medical University, Innsbruck A 6020, Austria

Univ.-Kklinik fuer Innere Medizin III, Salzburg 5020, Austria

Medical University of Vienna, Vienna 1090, Austria

Otto-Wagner-Spital, Wien 1140, Austria

UCL Saint Luc, Brussels 01200, Belgium

University Hospital Ghent, Ghent 9000, Belgium

CHU Sart Tilman, Liege 4000, Belgium

CHU de Besancon, Hopital Saint-Jacques, Besançon 25030, France

Hôpital de la Croix-Rousse, Lyon 69317, France

CHU Hôpital Gui de Chauliac, Montpellier 34295, France

Archet 1 Chu Nice Department of Infectology, Nice 06202, France

Maladies Infectieuses Dpt, Paris Cedex 13 75651, France

Hopital Saint Antoine, Paris 75012, France

Hôpital Bichat-Claude Bernard, Paris 75018, France

hôpital Tenon, Paris 75020, France

Saint-Louis Hospital, Paris 75010, France

Hôpital Haut Lévêque, Pessac 33604, France

Epimed GmbH, Berlin 12157, Germany

University of Bonn, Bonn 53127, Germany

Universitätsklinikum Essen, Dermatologie, HIV Ambulanz, Essen 45147, Germany

Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68, Frankfurt 60590, Germany

ICH Study Center, Hamburg 20146, Germany

Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie, Hamburg 20246, Germany

Medizinische Hochschule Hannover, Hannover 30625, Germany

Infektlonsambulanz Unlkllnik Koln, Koln 50937, Germany

Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen, Munich 80336, Germany

Ospedali Riuniti, Bergamo 24128, Italy

Clinic of Infectious Diseases, University of Milan-San Paolo Hospital, Milano 20142, Italy

Fondazione Centro San Raffaele, Milano 20127, Italy

Ospedale Luigi Sacco, Milano 20157, Italy

National Institute for Infectious Diseases "L. Spallanzani", Rome 00149, Italy

University of Torino, Dept of Infectious Disease, Torino 10122, Italy

HHP Hospital de Cascais, Alcabideche 2755, Portugal

Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa, Lisboa 1150-069, Portugal

Hospital de Santa Maria-CHLN, EPE, Lisbon 1049-035, Portugal

Clinical Research Puert Rico, San Juan 00909, Puerto Rico

University of Puerto Rico School of Medicine, San Juan 00935, Puerto Rico

Hospital General Universitario Alicante, Alicante 03010, Spain

Hospital clinic, Barcelona 08036, Spain

Hospital Germans Trias I Pujol, Barcelona 08916, Spain

Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service., Barcelona 08907, Spain

Hospital General Universitario de Elche, Elche, Alicante 03202, Spain

Hospital La Paz, Madrid 28760, Spain

Hospital Ramon y Cajal, Madrid 28034, Spain

Infectious Diseases Department, Hospital Carlos III, Madrid 28029, Spain

Hospital Virgen del Rocio, Sevilla 41013, Spain

Geneva University Hospital, Geneva 1205, Switzerland

University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology, Zurich 8091, Switzerland

Zentrum fur Infektionskrankheiten, Zurich CH-8038, Switzerland

Brighton and Sussex University Hospitals NHS Trust, Brighton BN21ES, United Kingdom

Chelsea and Westminster, London SW109NH, United Kingdom

Royal Free Hampstead NHS Trust, London NW32QG, United Kingdom

Pueblo Family Physicians, Phoenix, Arizona 85015, United States

Spectrum Medical Group, Phoenix, Arizona 85012, United States

AIDS Healthcare Foundation, Beverly Hills, California 90211, United States

Pacific Oaks Medical Group, Beverly Hills, California 90211, United States

Kaiser Permanente, Hayward, California 94545, United States

Anthony Mills MD Inc, Los Angeles, California 90069, United States

Kaiser Permanente, Los Angeles, California 90027, United States

OASIS Clinic, Los Angeles, California 90043, United States

Peter J. Ruane, M.D., Inc., Los Angeles, California 90036, United States

Stanford University, Palo Alto, California 94304, United States

Kaiser Permanente, Sacramento, California 95841, United States

University of California, Davis, Sacramento, California 95817, United States

La Playa Medical Group and Clinical Research, San Diego, California 92103, United States

Kaiser Permanente San Francisco, San Francisco, California 94118, United States

Metropolis Medical, San Francisco, California 94109, United States

Capital Medical Associates, PC, Washington, District of Columbia 20036, United States

Dupont Circle Physicians Group, P.C, Washington, District of Columbia 20009, United States

Gary Richmond, MD, Fort Lauderdale, Florida 33316, United States

Midway Immunology & Research Center, LLC, Fort Pierce, Florida 34982, United States

The Kinder Medical Group, Miami, Florida 33133, United States

Idocf/Valuhealthmd, Llc, Orlando, Florida 32806, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

Infectious Diseases Associates of NW FL, P.A., Pensacola, Florida 32504, United States

AHF Health Positive Tampa Bay, Safety Harbor, Florida 34695, United States

St. Joseph's Comprehensive Research Institute, Tampa, Florida 33614, United States

Atlanta ID Group, Atlanta, Georgia 30309, United States

John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center, Chicago, Illinois 60612, United States

Northwestern University Division of Infectious Diseases, Chicago, Illinois 60611, United States

Be Well Medical Center, Berkley, Michigan 48072, United States

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States

The Kansas City Free Health Clinic, Kansas City, Missouri 64111, United States

I.D. Care Associates PA, Hillsborough, New Jersey 08844, United States

Saint Michael's Medical Center, Newark, New Jersey 07102, United States

South Jersey Infectious Disease, Somers Point, New Jersey 08244, United States

Greiger Clinic, Mt. Vernon, New York 10550, United States

ID Consultants, P.A., Charlotte, North Carolina 28209, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Clinique Medicale Du Quartier Latin, Montreal, Quebec H2L 5B1, Canada

Southwest Infectious Disease Clinical Research, Inc, Dallas, Texas 75219, United States

Uptown Physicians Group, Dallas, Texas 75204, United States

Tarrant County Infectious Disease Associates, Fort Worth, Texas 76104, United States

Gordon Crofoot Md, Pa, Houston, Texas 77098, United States

St. Hope Foundation Inc, Houston, Texas 77401, United States

Therapeutic Concepts, PA, Houston, Texas 77004, United States

Additional Information

Starting date: November 2011
Last updated: January 22, 2015

Page last updated: August 23, 2015

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