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

April 21, 2016 updated by: Gilead Sciences

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

724

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
      • Darlinghurst, New South Wales, Australia, 2010
        • Ground Zero Medical Centre
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital, Sydney
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
      • Sidney, New South Wales, Australia, 2010
        • East Sidney Doctors
      • Sydney, New South Wales, Australia, 2010
        • Albion Street Centre
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
  • Belgium
      • Antwerp, Belgium, 2000
        • Institute of Tropical Medicine
      • Brussels, Belgium, 1070
        • Hopital Erasme
      • Brussels, Belgium, 1000
        • C.H.U. St Pierre
      • Charleroi, Belgium, 6000
        • CHU de Charleroi-Hopital civil
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege
  • Canada
      • Winnipeg, Canada, R3A 1R9
        • University of Manitoba - Health Sciences Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V35 4N9
        • Downtown Infectious Diseases Clinic
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network, Toronto General Hospital
      • Toronto, Ontario, Canada, M4T 3A7
        • CascAids Research
      • Toronto, Ontario, Canada, M5B 1L6
        • Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • Clinique médicale l'Actuel
      • Montreal, Quebec, Canada, H2X 2P4
        • Immunodeficiency Service, McGill University Health Centre (MUHC)
  • France
      • Le Kremlin Bicetre, France, 94270
        • Hopital de Bicentre - Service de medecine Interne et Immunologie
      • Montpellier, France, 34295
        • University Hospital of Montpellier - Gui de Chauliac
      • Nantes, France, 44093
        • CHU Nantes
      • Nice, France, 06202
        • C.H.U. de Nice - Hopital de l'Archet 1
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75012
        • Hopital Saint Antoine - Infectious Desease Department
      • Paris, France, 75013
        • Hopital Pitie Salpetriere - Infectious Deseases Department
      • Paris, France, 75018
        • APHP Hopital Bichat-Claude Bernard
      • Pessac, France, 33604
        • CHU Bordeaux
      • Toulouse, France, 31059
        • Hopital Purpan - Service of Infectious Diseases
  • Germany
      • Bonn, Germany, 53125
        • Universitatsklinikum Bonn
      • Dusseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Essen, Germany, 45122
        • Universitatklinikum Essen
      • Frankfurt, Germany, 60590
        • Klinikum der J.W. Goethe-Universitat
      • Hamburg, Germany, 20099
        • IFI-Institute
      • Hamburg, Germany, 20251
        • Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf
      • Kiel, Germany, 24116
        • Medizinische Universitatsklinik Kiel
      • Koln, Germany, 50937
        • Klinikum der Universität zu Köln
      • Munich, Germany, 80335
        • MUC Research
  • Italy
      • Bergamo, Italy, 24128
        • Ospedali Riuniti di Bergamo
      • Brescia, Italy, 25137
        • Spedali Civili di Brescia
      • Milan, Italy, 20157
        • Ospedale Luigi Sacco
      • Milan, Italy, 20127
        • Fondazione Centro San Raffaele del Monte Tabor
      • Milan, Italy, 20157
        • Ospedale L. Sacco
      • Rome, Italy, 00149
        • Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
      • Rome, Italy, 00161
        • Università La Sapienza Policlinico Umberto I
      • Rome, Italy, 00168
        • Universita' Cattolica del Sacro Cuore
  • Mexico
    • D.f.
      • Mexico, D.f., Mexico, 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ)
    • Guanajuato
      • Leon, Guanajuato, Mexico, 31320
        • Hospital Regional de Leon Guanajuato
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara
    • San Luis Potsi
      • San Luis Potosi, San Luis Potsi, Mexico, 78240
        • Hospital Central Morones Prieto
  • Netherlands
      • Rotterdam, Netherlands, 3000CA
        • Erasmus Medisch Centrum
  • Portugal
      • Amadora, Portugal, 2720-276
        • Hospital Fernando Fonseca
      • Lisbon, Portugal, 1649-035
        • Hospital de Santa Maria
      • Lisbon, Portugal, 1150-069
        • Hospital Santo Antonio dos Capuchos
      • Lisbon, Portugal, 1769-001
        • Hospital Pulido Valente
      • Porto, Portugal, 42020-451
        • Hospital de Sao Joao
  • Puerto Rico
      • Ponce, Puerto Rico, 00731
        • Instituto De Investigacion Cientifica Del Sur
      • San Juan, Puerto Rico, 00909
        • Hope Clinical Research
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico, Inc.
      • San Juan, Puerto Rico, 00921
        • VA Caribbean Healthcare System
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico, School of Medicine, Proyecto ACTU
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Cordoba, Spain, 14004
        • Hospital Reina Sofia
      • Elche, Spain, 03203
        • Hospital General Universitario del Elche
      • Granada, Spain, 18014
        • Hospital Clínico San Cecilio
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Madrid, Spain, 28041
        • Hospital Doce de Octubre
      • Malaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Vigo, Spain, 36204
        • Complexo Hospitalario Xeral-Cies (Chuvi) Vigo
  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Universitätsspital Zürich
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • RIDU, Western General Hospital
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust, St. Mary's Campus
      • London, United Kingdom, WC1E 6JB
        • Royal Free and University College Medical School
      • Manchester, United Kingdom, M8 6RB
        • North Manchester General Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Southwest Center For Hiv/Aids
    • Arkansas
      • Little Rock, Arkansas, United States, 72207
        • Health for Life Clinic, PLLC
    • California
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Medical Group
      • Beverly Hills, California, United States, 90804
        • AIDS Healthcare Foundation-Research Center
      • Fountain Valley, California, United States, 92708
        • Center for Special Immunology
      • Long Beach, California, United States, 90813
        • The Living Hope Foundation
      • Los Angeles, California, United States, 90028
        • Jeffrey Goodman Special Care Clinic
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente
      • Los Angeles, California, United States, 90036
        • Peter J. Ruane, MD, Inc.
      • Los Angeles, California, United States, 90033
        • University of Southern California, AIDS Clinical Trials Unit
      • Los Angeles, California, United States, 90069
        • Tony Mills, MD Internal Medicine
      • Newport Beach, California, United States, 92663
        • Orange Coast Medical Group
      • Oakland, California, United States, 94602
        • Alameda County Medical Center
      • Oakland, California, United States, 94609
        • East Bay AIDS Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente
      • San Diego, California, United States, 92103
        • David J. Shamblaw, MD Inc.
      • San Francisco, California, United States, 94115
        • Metropolis Medical
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center/UCSF
    • Connecticut
      • Glastonbury, Connecticut, United States, 06033
        • Connecticut Health Care Group
      • Norwalk, Connecticut, United States, 06851
        • Circle Medical LLC
      • Stamford, Connecticut, United States, 06902
        • The Stamford Hospital - Stamford ID
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Whitman-Walker Clinic
      • Washington, District of Columbia, United States, 20037
        • The George Washington University Medical Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • South Florida Clinical Research
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond, MD, PA, Inc.
      • Fort Lauderdale, Florida, United States, 33308
        • Lifeway , Inc.
      • Fort Lauderdale, Florida, United States, 33308
        • NorthPoint Medical
      • Fort Lauderdale, Florida, United States, 33308
        • Therafirst Medical Centers
      • Fort Lauderdale, Florida, United States, 33311
        • Broward Health CCC
      • Fort Pierce, Florida, United States, 34952
        • Associates in Infectious Diseases
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33133
        • The Kinder Medical Group
      • North Miami Beach, Florida, United States, 33169
        • Wohlfeiler, Piperato and Associates, LLC
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Orlando, Florida, United States, 32806
        • Infectious Disease of Central Florida
      • Safety Harbor, Florida, United States, 34695
        • Barry M. Rodwick, M. D.
      • Tampa, Florida, United States, 33614
        • St. Joseph's Comprehensive Research Institute
      • Vero Beach, Florida, United States, 32960
        • Treasure Coast Infectious Disease Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
      • Atlanta, Georgia, United States, 30309
        • Atlanta ID Group
      • Atlanta, Georgia, United States, 30308
        • The Emory Clinic, Inc., Division of Infectious Diseases
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialists of Atlanta (IDSA)
      • Macon, Georgia, United States, 31201
        • Mercer Univ. School of Medicine
      • Savannah, Georgia, United States, 31401
        • Chatham County Health Department
    • Hawaii
      • Honolulu, Hawaii, United States, 96316
        • Hawaii AIDS Clinical Research Program HACRP
    • Illinois
      • Chicago, Illinois, United States, 60613
        • Howard Brown Health Center
      • Chicago, Illinois, United States, 60657
        • Northstar Medical Center
      • Chicago, Illinois, United States, 60612
        • The Ruth M. Rothstein CORE Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Healthcare/Bluegrass Care Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Institute of Human Virology
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Community Research Initiative of New England
    • Michigan
      • Berkley, Michigan, United States, 48072
        • Be Well Medical Center
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Div of Infectious Disease
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St. Louis, Missouri, United States, 63139
        • Southampton Healthcare, Inc.
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center
      • Newark, New Jersey, United States, 07103
        • University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice
      • Somer Point, New Jersey, United States, 08244
        • South Jersey Infectious Disease
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Southwest C.A.R.E. Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Bronx, New York, United States, 10573
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11203
        • STAR Health Care Center
      • Mt. Vernon, New York, United States, 10550
        • Greiger Clinic
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10011
        • Ricky K. Hsu, MD, PC
      • New York, New York, United States, 10011
        • Chelsea Village Medical, PC
      • Rochester, New York, United States, 14604
        • AIDS Community HealthCenter
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit
      • Charlotte, North Carolina, United States, 28207
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medicine at East Carolina University
      • Huntersville, North Carolina, United States, 28078
        • Rosedale Infectious Diseases
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health CARE Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Jefferson Alumni Hall
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Dallas, Texas, United States, 75231
        • Presbyterian Hospital of Dallas
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Disease Consultants
      • Dallas, Texas, United States, 75215
        • AIDS Arms/ Peabody Health Center
      • Dallas, Texas, United States, 75219
        • Southwest Infectious Disease Clinical Research
      • Fort Worth, Texas, United States, 76104
        • Tarrant County Infectious Disease Associates
      • Harlingen, Texas, United States, 78550
        • Garcia Family Health Group
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77098
        • Gordon E. Crofoot, MD, PA
      • Houston, Texas, United States, 77098
        • The Schrader Clinic
      • Houston, Texas, United States, 77478
        • Joseph C. Gathe, JR. MD, F.A.C.P.
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
    • Washington
      • Spokane, Washington, United States, 99204
        • EHS Pulmonary and Critical Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elvitegravir

EVG 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.
Drug: Elvitegravir
Elvitegravir (EVG) tablet administered orally once daily with food
Other Names:
  • Vitekta®
  • GS-9137
Drug: RAL placebo
RAL placebo administered orally twice daily.
Drug: Background regimen
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.
Active Comparator: Raltegravir

RAL 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.
Drug: Background regimen
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.
Drug: Raltegravir
Raltegravir tablet administered orally twice daily according to prescribing information
Other Names:
  • Isentress®
Drug: EVG placebo
Placebo to match elvitegravir administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48
Time Frame: 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.
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96
Time Frame: 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.
Week 96
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48
Time Frame: 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.
Week 48
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96
Time Frame: 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.
Week 96
Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)
Time Frame: Week 48
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.
Week 48
Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)
Time Frame: Week 96
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.
Week 96
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48
Time Frame: Baseline 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.
Baseline to Week 48
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96
Time Frame: Baseline 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.
Baseline to Week 96
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48
Time Frame: Baseline 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.
Baseline to Week 48
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96
Time Frame: Baseline 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.
Baseline to Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Time Frame: 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.
Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Time Frame: Week 96
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.
Week 96
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Time Frame: Week 48
The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.
Week 48
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Time Frame: Week 96
The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.
Week 96
Change From Baseline in HIV-1 RNA at Week 48
Time Frame: Baseline to Week 48
The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.
Baseline to Week 48
Change From Baseline in HIV-1 RNA at Week 96
Time Frame: Baseline to Week 96
The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.
Baseline to Week 96
Change From Baseline in CD4 Cell Count at Week 48
Time Frame: Baseline to Week 48
The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.
Baseline to Week 48
Change From Baseline in CD4 Cell Count at Week 96
Time Frame: Baseline to Week 96
The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.
Baseline to Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Javier Szwarcberg, MD, MPH, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-183-0145
  • 2007-004225-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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