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Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF 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); FTC/TDF (Drug); NNRTI (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 noninferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate [EVG/COBI/FTC/TDF]) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus FTC/TDF 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 Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (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 stable on the current formulation(s) of an antiretroviral (ARV) regimen consisting

of an NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes those who began a regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs.

- Be on the first or second antiretroviral regimen with 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 at the screening visit

- Normal ECG

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

- Total bilirubin ≤ 1. 5 mg/dL

- Adequate hematologic function

- Serum amylase ≤ 5 × ULN

- Estimated glomerular filtration rate ≥ 70 mL/min

- Females of childbearing potential must agree to utilize protocol recommended

contraception methods or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants following the last dose of study drug

- Female participants 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 participants must agree to utilize protocol-recommended methods of contraception

during heterosexual intercourse or be nonheterosexually active, and practice sexual abstinence from the screening visit.

- Age ≥ 18 years

Exclusion Criteria:

- 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 those 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 (KS), basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and must not be anticipated to require systemic therapy during the study.

- Active, serious infections requiring parenteral antibiotic or antifungal therapy

within 30 days prior to baseline

- 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

- Receiving ongoing therapy with any of the medications, including drugs not to be used

with EVG, COBI, FTC, TDF; or those with any known allergies to the excipients of EVG/COBI/FTC/TDF tablets, or FTC/TDF 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 participant

unsuitable for the study or unable to comply with the dosing requirements

Locations and Contacts

Holdsworth House Medical Practice, Darlinghurst NSW 2010, Australia

Prahran Market Clinic, South Yarra VIC 3141, Australia

East Sydney Doctors, Sydney NSW 2010, Australia

Medical University of Vienna, Wien 1090, Austria

Otto Wagner Spital, Wien 1140, Austria

SEAMEO Regional Centre for Tropical Medicine, Antwerpen 2000, Belgium

Hôpitaux IRIS Sud, Bruxelles 1050, Belgium

University Hospital of Leuven, Leuven 3000, Belgium

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

Groupe Hospitalier Pellegrin, Bordeaux 33079, France

Hopital Bichat Claude Bernard, Paris 75018, France

Hopital Saint Antoine, Paris 75571, France

Hopital Saint Louis, Paris 75010, France

EPIMED GmbH, Berlin 12157, Germany

MIB Dienstleistung GmbH, Berlin 13353, Germany

Medizinische Universitätsklinik, Bonn 53127, Germany

Infektiologikum, Frankfurt 60596, Germany

Universitatsklinikum Freiburg, Freiburg 79106, Germany

ICH Study Center, Hamburg 20146, Germany

MUC Research GmbH, München 80335, Germany

Azienda Ospedaliera Ospedale di Circolo Busto Arsizio, Busto Arsizio/Varese 21052, Italy

Fondazione Centro San Raffaele del Monte Tabor, Milano 20127, Italy

Ospedale Luigi Sacco, Milano 20157, Italy

Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS, Roma 00149, Italy

Policlinico Universitario Agostino Gemelli, Rome 1214, Italy

Hospital de Santa Maria - CHLN EPE, Lisboa 1649-035, Portugal

Clinical Research Puerto Rico Inc, San Juan 00909, Puerto Rico

Hospital del Mar, Barcelona 8003, Spain

Hospital General Universitario Gregorio Maranon, Madrid 28007, Spain

Hospital La Fe de Valencia, Valencia 46009, Spain

Brighton and Sussex University Hospitals NHS Trust, Brighton BN2 1ES, United Kingdom

Western General Hospital, Edinburgh EH4 2XU, United Kingdom

Chelsea & Westminster Hospital, London SW10 9TH, United Kingdom

Homerton University Hospital, London E9 6SR, United Kingdom

South London Healthcare NHS Trust, London SE1 1EE, United Kingdom

St. Thomas' Hospital, London SE17EH, United Kingdom

Spectrum Medical Group, Phoenix, Arizona 85012, United States

AHF Research Center, Beverly Hills, California 90211, United States

Pacific Oak 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

OASIS Clinic, Los Angeles, California 90059, United States

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

Alameda County Medical Center, Oakland, California 94602, United States

Kaiser Permanente Medical Group, Sacramento, California 95825, United States

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

Kaiser Permanente, San Francisco, California 94118, United States

Metropolis Medical, San Francisco, California 94109, United States

Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña 08025, Spain

Capital Medical Associates, P.C., Washington, District of Columbia 20036, United States

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

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

Midway Immunology and Research, Fort Pierce, Florida 34982, United States

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

Orlando Immunology Center, Orlando, Florida 32803, United States

ValuHealth MD, LLC, Orlando, Florida 32806, United States

Infectious Diseases Associates of Northwest Florida, Pensacola, Florida 32504, United States

Health Positive, Safety Harbor, Florida 34684, United States

Hospital Clinico Universitario de Santiago, Santiago de Compostela, Galicia 15706, Spain

Atlanta ID Group, PC, Atlanta, Georgia 30309, United States

Infectious Disease Specialists of Atlanta, Decatur, Georgia 30033, United States

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

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

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

ID Care, 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

Aaron Diamond AIDS Research Center, New York, New York 10016, United States

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

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

Maple Leaf Medical Clinic, Toronto, Ontario M5B1L6, Canada

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

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States

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

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

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

Gordon E. Crofoot MD, PA, Houston, Texas 77098, United States

Therapeutic Concepts PA, Houston, Texas 77004, United States

Clinical Alliance for Research & Education - Infectious Disease, Annandale, Virginia 22003, United States

Additional Information

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

Page last updated: August 23, 2015

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