AzTrials
AzTrials

HIV InfectionPhase 3NCT00708162

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

A Phase 3 study testing Elvitegravir, Raltegravir and Background regimen in people with HIV Infection, run by Gilead Sciences at 180 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
Elvitegravir, Raltegravir and Background regimen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
724 participants
Where
180 sitesin 14 countries
Study dates
Jul 2008to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
  • Documented resistance or at least six months experience prior to screening with two or more different classes of antiretroviral agents
  • Stable antiretroviral regimen for at least 30 days prior to screening: however, participants may discontinue the antiretroviral regimen after screening and remain off therapy until baseline at the discretion of the investigator
  • Eligible to receive one of the fully-active ritonavir-boosted-PIs, and an allowed second agent
  • Normal ECG
  • Adequate renal function (estimated glomerular filtration rate according to the Cockcroft-Gault formula ≥ 60 mL/min)
Show all 15Show fewer
  • Hepatic transaminases ≤ 5 × upper limit of normal
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
  • Serum amylase < 1.5 × the upper limit of the normal range
  • Negative serum pregnancy test (females of childbearing potential only)
  • Males and females of childbearing potential must agree to use highly effective contraception methods
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year
  • Ability to understand and sign a written informed consent form

Who cannot join

  • New AIDS-defining condition diagnosed within the 30 days prior to screening
  • Prior treatment with any HIV-1 integrase inhibitor
  • Participants experiencing ascites
  • Participants experiencing encephalopathy
  • Females who are breastfeeding
  • Positive serum pregnancy test at any time during the study (female of childbearing potential)
Show all 13Show fewer
  • Participants receiving ongoing therapy with any disallowed medication
  • Current alcohol or substance use judged by the investigator to potentially interfere with study compliance
  • Malignancy other than cutaneous Kaposi's sarcoma or basal cell carcinoma
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Participation in any other clinical trial (except for the etravirine or maraviroc expanded access program), without prior approval from sponsor
  • Any other clinical condition or prior therapy that would make participants unsuitable for the study
  • Known hypersensitivity to study drug, metabolites or formulation excipients

Trial locations and contacts

180 sites in 14 countries.

180 sites in 14 countries

United States94 sites

  • Summa Health CARE Center

    Akron, Ohio, 44304

  • Albany Medical College

    Albany, New York, 12208

  • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • The Emory Clinic, Inc., Division of Infectious Diseases

    Atlanta, Georgia, 30308

  • Atlanta ID Group

    Atlanta, Georgia, 30309

  • South Florida Clinical Research

    Atlantis, Florida, 33462

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • University of Maryland, Institute of Human Virology

    Baltimore, Maryland, 21201

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • AIDS Healthcare Foundation-Research Center

    Beverly Hills, California, 90804

  • Community Research Initiative of New England

    Boston, Massachusetts, 02215

  • STAR Health Care Center

    Brooklyn, New York, 11203

  • University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit

    Chapel Hill, North Carolina, 27514

  • Carolinas Medical Center

    Charlotte, North Carolina, 28207

  • The Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • Northstar Medical Center

    Chicago, Illinois, 60657

  • AIDS Arms/ Peabody Health Center

    Dallas, Texas, 75215

  • Southwest Infectious Disease Clinical Research

    Dallas, Texas, 75219

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • North Texas Infectious Disease Consultants

    Dallas, Texas, 75246

  • Infectious Disease Specialists of Atlanta (IDSA)

    Decatur, Georgia, 30033

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Hospital Div of Infectious Disease

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • Lifeway , Inc.

    Fort Lauderdale, Florida, 33308

  • NorthPoint Medical

    Fort Lauderdale, Florida, 33308

  • Therafirst Medical Centers

    Fort Lauderdale, Florida, 33308

  • Broward Health CCC

    Fort Lauderdale, Florida, 33311

  • Gary Richmond, MD, PA, Inc.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Center for Special Immunology

    Fountain Valley, California, 92708

  • Associates In Infectious Diseases

    Ft. Pierce, Florida, 34952

  • Connecticut Health Care Group

    Glastonbury, Connecticut, 06033

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27834

  • Garcia Family Health Group

    Harlingen, Texas, 78550

  • ID Care

    Hillsborough, New Jersey, 08844

  • Hawaii AIDS Clinical Research Program HACRP

    Honolulu, Hawaii, 96316

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Gordon E. Crofoot, MD, PA

    Houston, Texas, 77098

  • The Schrader Clinic

    Houston, Texas, 77098

  • Joseph C. Gathe, JR. MD, F.A.C.P.

    Houston, Texas, 77478

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • University of Kentucky Healthcare/Bluegrass Care Clinic

    Lexington, Kentucky, 40536

  • Health for Life Clinic, PLLC

    Little Rock, Arkansas, 72207

  • The Living Hope Foundation

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Jeffrey Goodman Special Care Clinic

    Los Angeles, California, 90028

  • University of Southern California, AIDS Clinical Trials Unit

    Los Angeles, California, 90033

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • Tony Mills, MD Internal Medicine

    Los Angeles, California, 90069

  • Mercer Univ. School of Medicine

    Macon, Georgia, 31201

  • The Kinder Medical Group

    Miami, Florida, 33133

  • University of Miami

    Miami, Florida, 33136

  • Greiger Clinic

    Mount Vernon, New York, 10550

  • Beth Israel Medical Center

    New York, New York, 10003

  • Chelsea Village Medical, PC

    New York, New York, 10011

  • Ricky K. Hsu, MD, PC

    New York, New York, 10011

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice

    Newark, New Jersey, 07103

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • Wohlfeiler, Piperato and Associates, LLC

    North Miami Beach, Florida, 33169

  • Circle Medical LLC

    Norwalk, Connecticut, 06851

  • Alameda County Medical Center

    Oakland, California, 94602

  • East Bay AIDS Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Infectious Disease of Central Florida

    Orlando, Florida, 32806

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Jefferson Alumni Hall

    Philadelphia, Pennsylvania, 19107

  • Southwest Center for HIV/AIDS

    Phoenix, Arizona, 85006

  • AIDS Community HealthCenter

    Rochester, New York, 14604

  • Kaiser Permanente

    Sacramento, California, 95825

  • Barry M. Rodwick, M. D.

    Safety Harbor, Florida, 34695

  • David J. Shamblaw, MD Inc.

    San Diego, California, 92103

  • Metropolis Medical

    San Francisco, California, 94115

  • San Francisco VA Medical Center/UCSF

    San Francisco, California, 94121

  • Southwest C.A.R.E. Center

    Santa Fe, New Mexico, 87505

  • Chatham County Health Department

    Savannah, Georgia, 31401

  • South Jersey Infectious Disease

    Somer Point, New Jersey, 08244

  • EHS Pulmonary and Critical Care

    Spokane, Washington, 99204

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • The Stamford Hospital - Stamford ID

    Stamford, Connecticut, 06902

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10573

  • Treasure Coast Infectious Disease Consultants

    Vero Beach, Florida, 32960

  • Whitman-Walker Clinic

    Washington D.C., District of Columbia, 20009

  • The George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain16 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario del Elche

    Elche, 03203

  • Hospital Clinico San Cecilio

    Granada, 18014

  • Hospital La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Doce De Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Virgen del Rocio

    Seville, 41013

  • Complexo Hospitalario Xeral-Cies (Chuvi) Vigo

    Vigo, 36204

Other trials in Spain

France11 sites

  • Hopital de Bicentre - Service de medecine Interne et Immunologie

    Le Kremlin-Bicêtre, 94270

  • University Hospital of Montpellier - Gui de Chauliac

    Montpellier, 34295

  • CHU Nantes

    Nantes, 44093

  • C.H.U. de Nice - Hopital de l'Archet 1

    Nice, 06202

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Saint Antoine - Infectious Desease Department

    Paris, 75012

  • Hopital Pitie Salpetriere - Infectious Deseases Department

    Paris, 75013

  • APHP Hopital Bichat-Claude Bernard

    Paris, 75018

  • Hopital Tenon

    Paris, 75020

  • CHU Bordeaux

    Pessac, 33604

  • Hopital Purpan - Service of Infectious Diseases

    Toulouse, 31059

Other trials in France

Canada9 sites

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Clinique medicale l'Actuel

    Montreal, Quebec, H2L 4P9

  • Immunodeficiency Service, McGill University Health Centre (MUHC)

    Montreal, Quebec, H2X 2P4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • CascAids Research

    Toronto, Ontario, M4T 3A7

  • Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

    Toronto, Ontario, M5B 1L6

  • University Health Network, Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Downtown Infectious Diseases Clinic

    Vancouver, British Columbia, V35 4N9

  • University of Manitoba - Health Sciences Centre

    Winnipeg, R3A 1R9

Other trials in Canada

Germany9 sites

  • Universitatsklinikum Bonn

    Bonn, 53125

  • Klinikum der Universitat zu Koln

    Cologne, 50937

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225

  • Universitatklinikum Essen

    Essen, 45122

  • Klinikum der J.W. Goethe-Universitat

    Frankfurt, 60590

  • IFI-Institute

    Hamburg, 20099

  • Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251

  • Medizinische Universitatsklinik Kiel

    Kiel, 24116

  • MUC Research

    Munich, 80335

Other trials in Germany

Australia8 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Ground Zero Medical Centre

    Darlinghurst, New South Wales, 2010

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales, 2010

  • St. Vincent's Hospital, Sydney

    Darlinghurst, New South Wales, 2010

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Albion Street Centre

    Sydney, New South Wales, 2010

  • East Sidney Doctors

    Sydney, New South Wales, 2010

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

Other trials in Australia

Italy8 sites

  • Ospedali Riuniti Di Bergamo

    Bergamo, 24128

  • Spedali Civili di Brescia

    Brescia, 25137

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20127

  • Ospedale L. Sacco

    Milan, 20157

  • Ospedale Luigi Sacco

    Milan, 20157

  • Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

    Rome, 00149

  • Universita La Sapienza Policlinico Umberto I

    Rome, 00161

  • Universita' Cattolica Del Sacro Cuore

    Rome, 00168

Other trials in Italy

Belgium5 sites

  • Institute of Tropical Medicine

    Antwerp, 2000

  • C.H.U. St Pierre

    Brussels, 1000

  • Hôpital Erasme

    Brussels, 1070

  • CHU de Charleroi-Hopital civil

    Charleroi, 6000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

Portugal5 sites

  • Hospital Fernando Fonseca

    Amadora, 2720-276

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1150-069

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital Pulido Valente

    Lisbon, 1769-001

  • Hospital de Sao Joao

    Porto, 42020-451

Other trials in Portugal

Puerto Rico5 sites

  • Instituto de Investigacion Cientifica del Sur

    Ponce, 00731

  • Clinical Research Puerto Rico, Inc.

    San Juan, 00909

  • HOPE Clinical Research

    San Juan, 00909

  • VA Caribbean healthcare System

    San Juan, 00921

  • University of Puerto Rico, School of Medicine, Proyecto ACTU

    San Juan, 00936

Other trials in Puerto Rico

Mexico4 sites

  • Hospital Civil de Guadalajara

    Guadalajara, Jalisco, 44280

  • Hospital Regional de Leon Guanajuato

    León, Guanajuato, 31320

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ)

    México, D.f., 14000

  • Hospital Central Morones Prieto

    San Luis Potosí City, San Luis Potsi, 78240

Other trials in Mexico

United Kingdom4 sites

  • RIDU, Western General Hospital

    Edinburgh, EH4 2XU

  • Imperial College Healthcare NHS Trust, St. Mary's Campus

    London, W2 1NY

  • Royal Free and University College Medical School

    London, WC1E 6JB

  • North Manchester General Hospital

    Manchester, M8 6RB

Other trials in United Kingdom

Netherlands1 site

  • Erasmus Medisch Centrum

    Rotterdam, 3000CA

Other trials in Netherlands

Switzerland1 site

  • Universitatsspital Zurich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents.

Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).

Read the detailed description

The background regimen will be constructed by the investigator based on viral resistance testing. The fully active PI will be defined by phenotypic resistance analysis. For phenotypic susceptibility, fully active is defined as being below the lower clinical or biological cutoff. Participants are required to take their ritonavir dose based on the dosing schedule indicated in the prescribing information for the PI; no additional ritonavir is required to be taken with EVG. No other marketed PIs are allowed as part of the background regimen due to unknown drug interactions.

The second agent can be one nucleoside or nucleotide reverse transcriptase inhibitor (NRTI), etravirine, maraviroc, or T-20. However, the second agent must not include an integrase inhibitor; the nonnucleoside reverse transcriptase inhibitors efavirenz, nevirapine, or delavirdine (due to unknown drug interactions); or the fixed-dose combination therapies Atripla® or Trizivir® (abacavir sulfate/lamivudine/zidovudine). The second agent may or may not be fully active (except in Spain, where participants have to receive a fully active second agent, as requested by the Spanish regulatory agency).

If the M184V/I reverse transcriptase (RT) mutation is present on the screening genotype report and an NRTI is used as the second agent, then either FTC or LAM may be added as a third agent in the background regimen to maintain the M184V/I mutation. In this situation only, the fixed-dose combination therapies Combivir®, Truvada®, or Epzicom/Kivexa® may be prescribed as the combined second and third agents of the background regimen.

After Week 96, participants will continue to take their blinded study drug and attend visits until treatment assignments are unblinded, at which point they will be given the option to participate in an open-label EVG extension phase of the study.

Conditions
HIV Infection
Being tested
Elvitegravir, Raltegravir, EVG placebo, RAL placebo, Background regimen
Keywords
HIV, HIV I, Treatment Experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElvitegravirDrug

    Also called Vitekta®, GS-9137

    Elvitegravir (EVG) tablet administered orally once daily with food

  • RaltegravirDrug

    Also called Isentress®

    Raltegravir tablet administered orally twice daily according to prescribing information

  • EVG placeboDrug

    Placebo to match elvitegravir administered orally once daily

  • RAL placeboDrug

    RAL placebo administered orally twice daily.

  • Background regimenDrug

    Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.

Study groups in NCT00708162
Study groupRoleWhat they receive
ElvitegravirExperimentalEVG 85 mg or 150 mg + RAL placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background regimen in the Open-Label Phase. Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their background regimen will receive EVG 85 mg; all other participants will receive EVG 150 mg.
Receives: Drug: Elvitegravir; Drug: RAL placebo; Drug: Background regimen
RaltegravirActive comparatorRAL 800 mg (400 mg twice daily) + EVG placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background regimen in the Open-Label Phase. Participants receiving LPV/r or ATV/r as part of their background regimen in the Open-Label Phase will receive EVG 85 mg; all other participants will receive EVG 150 mg.
Receives: Drug: Raltegravir; Drug: EVG placebo; Drug: Background regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48

    The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

    Measured: Week 48

Secondary outcomes (17)

  1. Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96

    The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

    Measured: Week 96

  2. Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48

    The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

    Measured: Week 48

  3. Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96

    The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

    Measured: Week 96

  4. Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)

    Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.

    Measured: Week 48

  5. Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)

    Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.

    Measured: Week 96

  6. Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48

    The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.

    Measured: Baseline to Week 48

  7. Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96

    The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.

    Measured: Baseline to Week 96

  8. Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48

    The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.

    Measured: Baseline to Week 48

  9. Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96

    The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.

    Measured: Baseline to Week 96

  10. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.

    Measured: Week 48

  11. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.

    Measured: Week 96

  12. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.

    Measured: Week 48

  13. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.

    Measured: Week 96

  14. Change From Baseline in HIV-1 RNA at Week 48

    The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.

    Measured: Baseline to Week 48

  15. Change From Baseline in HIV-1 RNA at Week 96

    The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.

    Measured: Baseline to Week 96

  16. Change From Baseline in CD4 Cell Count at Week 48

    The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.

    Measured: Baseline to Week 48

  17. Change From Baseline in CD4 Cell Count at Week 96

    The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.

    Measured: Baseline to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2010
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
724 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00708162
Sponsor's protocol ID
GS-US-183-0145
Other IDs
2007-004225-26
Status last verified
Apr 2016
First submitted
30 Jun 2008
Last updated
30 May 2016
Data monitoring committee
Yes

Publications

  • Molina JM, Lamarca A, Andrade-Villanueva J, Clotet B, Clumeck N, Liu YP, Zhong L, Margot N, Cheng AK, Chuck SL; Study 145 Team. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. Lancet Infect Dis. 2012 Jan;12(1):27-35. doi: 10.1016/S1473-3099(11)70249-3. Epub 2011 Oct 18.

    PubMed 22015077

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elvitegravir, Raltegravir and Background regimen in people with HIV Infection, run by Gilead Sciences at 180 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in United States, Spain, France, Canada, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00708162, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.

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Clinical Trial NCT00708162 | AzTrials