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

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elvitegravir
Raltegravir
EVG placebo
RAL placebo
Background regimen
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, HIV I, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Center for HIV/AIDS
  • Health for Life Clinic, PLLC
  • Pacific Oaks Medical Group
  • AIDS Healthcare Foundation-Research Center
  • Center for Special Immunology
  • The Living Hope Foundation
  • Kaiser Permanente
  • Jeffrey Goodman Special Care Clinic
  • University of Southern California, AIDS Clinical Trials Unit
  • Peter J. Ruane, MD, Inc.
  • Tony Mills, MD Internal Medicine
  • Orange Coast Medical Group
  • Alameda County Medical Center
  • East Bay AIDS Center
  • Kaiser Permanente
  • David J. Shamblaw, MD Inc.
  • Metropolis Medical
  • San Francisco VA Medical Center/UCSF
  • Connecticut Health Care Group
  • Circle Medical LLC
  • The Stamford Hospital - Stamford ID
  • Whitman-Walker Clinic
  • The George Washington University Medical Center
  • South Florida Clinical Research
  • Lifeway , Inc.
  • NorthPoint Medical
  • Therafirst Medical Centers
  • Broward Health CCC
  • Gary Richmond, MD, PA, Inc.
  • Associates In Infectious Diseases
  • The Kinder Medical Group
  • University of Miami
  • Wohlfeiler, Piperato and Associates, LLC
  • Orlando Immunology Center
  • Infectious Disease of Central Florida
  • Barry M. Rodwick, M. D.
  • St. Joseph's Comprehensive Research Institute
  • Treasure Coast Infectious Disease Consultants
  • AIDS Research Consortium of Atlanta
  • The Emory Clinic, Inc., Division of Infectious Diseases
  • Atlanta ID Group
  • Infectious Disease Specialists of Atlanta (IDSA)
  • Mercer Univ. School of Medicine
  • Chatham County Health Department
  • Hawaii AIDS Clinical Research Program HACRP
  • The Ruth M. Rothstein CORE Center
  • Howard Brown Health Center
  • Northstar Medical Center
  • University of Kentucky Healthcare/Bluegrass Care Clinic
  • University of Maryland, Institute of Human Virology
  • Community Research Initiative of New England
  • Be Well Medical Center
  • Wayne State University
  • Henry Ford Hospital Div of Infectious Disease
  • Washington University School of Medicine
  • Southampton Healthcare, Inc.
  • ID Care
  • Saint Michael's Medical Center
  • University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice
  • South Jersey Infectious Disease
  • Southwest C.A.R.E. Center
  • Albany Medical College
  • Montefiore Medical Center
  • STAR Health Care Center
  • Greiger Clinic
  • Beth Israel Medical Center
  • Chelsea Village Medical, PC
  • Ricky K. Hsu, MD, PC
  • Mount Sinai School of Medicine
  • AIDS Community HealthCenter
  • University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit
  • Carolinas Medical Center
  • Duke University
  • Brody School of Medicine at East Carolina University
  • Rosedale Infectious Diseases
  • Wake Forest University Health Sciences
  • Summa Health CARE Center
  • University of Pennsylvania
  • Philadelphia FIGHT
  • Thomas Jefferson University Jefferson Alumni Hall
  • Central Texas Clinical Research
  • AIDS Arms/ Peabody Health Center
  • Southwest Infectious Disease Clinical Research
  • Presbyterian Hospital of Dallas
  • North Texas Infectious Disease Consultants
  • Tarrant County Infectious Disease Associates
  • Garcia Family Health Group
  • University of Texas Health Science Center at Houston
  • Gordon E. Crofoot, MD, PA
  • The Schrader Clinic
  • Joseph C. Gathe, JR. MD, F.A.C.P.
  • DCOL Center for Clinical Research
  • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
  • EHS Pulmonary and Critical Care
  • Royal Prince Alfred Hospital
  • Ground Zero Medical Centre
  • Holdsworth House Medical Practice
  • St. Vincent's Hospital, Sydney
  • St George Hospital
  • East Sidney Doctors
  • Albion Street Centre
  • Westmead Hospital
  • Institute of Tropical Medicine
  • C.H.U. St Pierre
  • Hôpital Erasme
  • CHU de Charleroi-Hopital civil
  • Centre Hospitalier Universitaire de Liège
  • Downtown Infectious Diseases Clinic
  • Queen Elizabeth II Health Sciences Centre
  • Sunnybrook Health Sciences Centre
  • CascAids Research
  • Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
  • University Health Network, Toronto General Hospital
  • Clinique medicale l'Actuel
  • Immunodeficiency Service, McGill University Health Centre (MUHC)
  • University of Manitoba - Health Sciences Centre
  • Hopital de Bicentre - Service de medecine Interne et Immunologie
  • University Hospital of Montpellier - Gui de Chauliac
  • CHU Nantes
  • C.H.U. de Nice - Hopital de l'Archet 1
  • Hopital Saint Louis
  • Hopital Saint Antoine - Infectious Desease Department
  • Hopital Pitie Salpetriere - Infectious Deseases Department
  • APHP Hopital Bichat-Claude Bernard
  • Hopital Tenon
  • CHU Bordeaux
  • Hopital Purpan - Service of Infectious Diseases
  • Universitatsklinikum Bonn
  • Universitatsklinikum Dusseldorf
  • Universitatklinikum Essen
  • Klinikum der J.W. Goethe-Universitat
  • IFI-Institute
  • Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf
  • Medizinische Universitatsklinik Kiel
  • Klinikum der Universitat zu Koln
  • MUC Research
  • Ospedali Riuniti Di Bergamo
  • Spedali Civili di Brescia
  • Fondazione Centro San Raffaele del Monte Tabor
  • Ospedale L. Sacco
  • Ospedale Luigi Sacco
  • Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
  • Universita La Sapienza Policlinico Umberto I
  • Universita' Cattolica Del Sacro Cuore
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ)
  • Hospital Regional de Leon Guanajuato
  • Hospital Civil de Guadalajara
  • Hospital Central Morones Prieto
  • Erasmus Medisch Centrum
  • Hospital Fernando Fonseca
  • Hospital Santo Antonio dos Capuchos
  • Hospital de Santa Maria
  • Hospital Pulido Valente
  • Hospital de Sao Joao
  • Instituto de Investigacion Cientifica del Sur
  • Clinical Research Puerto Rico, Inc.
  • HOPE Clinical Research
  • VA Caribbean healthcare System
  • University of Puerto Rico, School of Medicine, Proyecto ACTU
  • Hospital General Universitario de Alicante
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Reina Sofia
  • Hospital General Universitario del Elche
  • Hospital Clinico San Cecilio
  • Hospital La Princesa
  • Hospital General Universitario Gregorio Maranon
  • Hospital Ramon y Cajal
  • Hospital Doce De Octubre
  • Hospital Universitario La Paz
  • Hospital Virgen de la Victoria
  • Hospital Universitario de Canarias
  • Hospital Virgen del Rocio
  • Complexo Hospitalario Xeral-Cies (Chuvi) Vigo
  • Universitatsspital Zurich
  • RIDU, Western General Hospital
  • Imperial College Healthcare NHS Trust, St. Mary's Campus
  • Royal Free and University College Medical School
  • North Manchester General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elvitegravir

Raltegravir

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 30, 2008
Last Updated
April 21, 2016
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00708162
Brief Title
Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, HIV I, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
724 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elvitegravir
Arm Type
Experimental
Arm Description
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.
Arm Title
Raltegravir
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Elvitegravir
Other Intervention Name(s)
Vitekta®, GS-9137
Intervention Description
Elvitegravir (EVG) tablet administered orally once daily with food
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Other Intervention Name(s)
Isentress®
Intervention Description
Raltegravir tablet administered orally twice daily according to prescribing information
Intervention Type
Drug
Intervention Name(s)
EVG placebo
Intervention Description
Placebo to match elvitegravir administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RAL placebo
Intervention Description
RAL placebo administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Background regimen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48
Description
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.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96
Description
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.
Time Frame
Week 96
Title
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48
Description
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.
Time Frame
Week 48
Title
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96
Description
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.
Time Frame
Week 96
Title
Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)
Description
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.
Time Frame
Week 48
Title
Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)
Description
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.
Time Frame
Week 96
Title
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48
Description
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.
Time Frame
Baseline to Week 48
Title
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96
Description
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.
Time Frame
Baseline to Week 96
Title
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48
Description
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.
Time Frame
Baseline to Week 48
Title
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96
Description
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.
Time Frame
Baseline to Week 96
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Description
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.
Time Frame
Week 48
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Description
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.
Time Frame
Week 96
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Description
The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.
Time Frame
Week 48
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Description
The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.
Time Frame
Week 96
Title
Change From Baseline in HIV-1 RNA at Week 48
Description
The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.
Time Frame
Baseline to Week 48
Title
Change From Baseline in HIV-1 RNA at Week 96
Description
The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.
Time Frame
Baseline to Week 96
Title
Change From Baseline in CD4 Cell Count at Week 48
Description
The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.
Time Frame
Baseline to Week 48
Title
Change From Baseline in CD4 Cell Count at Week 96
Description
The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.
Time Frame
Baseline to Week 96

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
22015077
Citation
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.
Results Reference
result

Learn more about this trial

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

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