Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir
- Conditions
- HIV Infection
- Interventions
- Registration Number
- NCT00708162
- Lead Sponsor
- Gilead Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 724
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Raltegravir 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. Elvitegravir Background regimen 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. Raltegravir EVG placebo 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. Raltegravir Background regimen 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. Elvitegravir RAL placebo 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. Elvitegravir 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 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
Name Time Method Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96 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.
Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL) 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.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 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 Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96 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.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 Week 48 The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed using the missing = failure method.
Change From Baseline in HIV-1 RNA at Week 96 Baseline to Week 96 The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96 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.
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48 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.
Change From Baseline in CD4 Cell Count at Week 96 Baseline to Week 96 The change from baseline in CD4 cell count (cells/mm\^3) at Week 96 was analyzed.
Change From Baseline in HIV-1 RNA at Week 48 Baseline to Week 48 The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48 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 With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48 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.
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96 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.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Week 96 The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the missing = failure method.
Change From Baseline in CD4 Cell Count at Week 48 Baseline to Week 48 The change from baseline in CD4 cell count (cells/mm\^3) at Week 48 was analyzed.
Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL) 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.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 Week 96 The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 96 was analyzed using the missing = failure method.
Trial Locations
- Locations (179)
Whitman-Walker Clinic
🇺🇸Washington, District of Columbia, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
ID Care
🇺🇸Hillsborough, New Jersey, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
South Jersey Infectious Disease
🇺🇸Somer Point, New Jersey, United States
Institute of Tropical Medicine
🇧🇪Antwerp, Belgium
CHU de Charleroi-Hopital civil
🇧🇪Charleroi, Belgium
Hôpital Erasme
🇧🇪Brussels, Belgium
Clinique medicale l'Actuel
🇨🇦Montreal, Quebec, Canada
Hospital Santo Antonio dos Capuchos
🇵🇹Lisbon, Portugal
Immunodeficiency Service, McGill University Health Centre (MUHC)
🇨🇦Montreal, Quebec, Canada
Downtown Infectious Diseases Clinic
🇨🇦Vancouver, British Columbia, Canada
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ)
🇲🇽Mexico, D.f., Mexico
Hospital Central Morones Prieto
🇲🇽San Luis Potosi, San Luis Potsi, Mexico
HOPE Clinical Research
🇵🇷San Juan, Puerto Rico
Hospital Civil de Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
Clinical Research Puerto Rico, Inc.
🇵🇷San Juan, Puerto Rico
Peter J. Ruane, MD, Inc.
🇺🇸Los Angeles, California, United States
Circle Medical LLC
🇺🇸Norwalk, Connecticut, United States
Northstar Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland, Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Southwest Infectious Disease Clinical Research
🇺🇸Dallas, Texas, United States
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
🇨🇦Toronto, Ontario, Canada
Community Research Initiative of New England
🇺🇸Boston, Massachusetts, United States
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital de Sao Joao
🇵🇹Porto, Portugal
Jeffrey Goodman Special Care Clinic
🇺🇸Los Angeles, California, United States
Connecticut Health Care Group
🇺🇸Glastonbury, Connecticut, United States
Infectious Disease Specialists of Atlanta (IDSA)
🇺🇸Decatur, Georgia, United States
The Ruth M. Rothstein CORE Center
🇺🇸Chicago, Illinois, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Health for Life Clinic, PLLC
🇺🇸Little Rock, Arkansas, United States
Infectious Disease of Central Florida
🇺🇸Orlando, Florida, United States
St. Joseph's Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Southampton Healthcare, Inc.
🇺🇸St. Louis, Missouri, United States
Orange Coast Medical Group
🇺🇸Newport Beach, California, United States
The Emory Clinic, Inc., Division of Infectious Diseases
🇺🇸Atlanta, Georgia, United States
Broward Health CCC
🇺🇸Fort Lauderdale, Florida, United States
Alameda County Medical Center
🇺🇸Oakland, California, United States
Pacific Oaks Medical Group
🇺🇸Beverly Hills, California, United States
The Stamford Hospital - Stamford ID
🇺🇸Stamford, Connecticut, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
AIDS Healthcare Foundation-Research Center
🇺🇸Beverly Hills, California, United States
The Living Hope Foundation
🇺🇸Long Beach, California, United States
Hospital de Santa Maria
🇵🇹Lisbon, Portugal
Barry M. Rodwick, M. D.
🇺🇸Safety Harbor, Florida, United States
AIDS Arms/ Peabody Health Center
🇺🇸Dallas, Texas, United States
Presbyterian Hospital of Dallas
🇺🇸Dallas, Texas, United States
Ricky K. Hsu, MD, PC
🇺🇸New York, New York, United States
AIDS Community HealthCenter
🇺🇸Rochester, New York, United States
Associates In Infectious Diseases
🇺🇸Fort Pierce, Florida, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Southwest C.A.R.E. Center
🇺🇸Santa Fe, New Mexico, United States
Rosedale Infectious Diseases
🇺🇸Huntersville, North Carolina, United States
University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice
🇺🇸Newark, New Jersey, United States
Greiger Clinic
🇺🇸Mt. Vernon, New York, United States
C.H.U. St Pierre
🇧🇪Brussels, Belgium
North Texas Infectious Disease Consultants
🇺🇸Dallas, Texas, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
C.H.U. de Nice - Hopital de l'Archet 1
🇫🇷Nice, France
Joseph C. Gathe, JR. MD, F.A.C.P.
🇺🇸Houston, Texas, United States
Universitatsklinikum Dusseldorf
🇩🇪Dusseldorf, Germany
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Holdsworth House Medical Practice
🇦🇺Darlinghurst, New South Wales, Australia
IFI-Institute
🇩🇪Hamburg, Germany
Hopital Purpan - Service of Infectious Diseases
🇫🇷Toulouse, France
Thomas Jefferson University Jefferson Alumni Hall
🇺🇸Philadelphia, Pennsylvania, United States
The Schrader Clinic
🇺🇸Houston, Texas, United States
Ospedali Riuniti Di Bergamo
🇮🇹Bergamo, Italy
University Hospital of Montpellier - Gui de Chauliac
🇫🇷Montpellier, France
Universitatklinikum Essen
🇩🇪Essen, Germany
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Hopital Saint Louis
🇫🇷Paris, France
Hopital Saint Antoine - Infectious Desease Department
🇫🇷Paris, France
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Summa Health CARE Center
🇺🇸Akron, Ohio, United States
Chelsea Village Medical, PC
🇺🇸New York, New York, United States
CascAids Research
🇨🇦Toronto, Ontario, Canada
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Hopital Pitie Salpetriere - Infectious Deseases Department
🇫🇷Paris, France
Ospedale L. Sacco
🇮🇹Milan, Italy
CHU Nantes
🇫🇷Nantes, France
Hospital Fernando Fonseca
🇵🇹Amadora, Portugal
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Hopital de Bicentre - Service de medecine Interne et Immunologie
🇫🇷Le Kremlin Bicetre, France
University Health Network, Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Imperial College Healthcare NHS Trust, St. Mary's Campus
🇬🇧London, United Kingdom
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
🇺🇸Annandale, Virginia, United States
Hospital Reina Sofia
🇪🇸Cordoba, Spain
Royal Free and University College Medical School
🇬🇧London, United Kingdom
APHP Hopital Bichat-Claude Bernard
🇫🇷Paris, France
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Spain
Tarrant County Infectious Disease Associates
🇺🇸Fort Worth, Texas, United States
Hospital Regional de Leon Guanajuato
🇲🇽Leon, Guanajuato, Mexico
Centre Hospitalier Universitaire de Liège
🇧🇪Liege, Belgium
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Universita La Sapienza Policlinico Umberto I
🇮🇹Rome, Italy
Hospital La Princesa
🇪🇸Madrid, Spain
University of Manitoba - Health Sciences Centre
🇨🇦Winnipeg, Canada
Hospital Pulido Valente
🇵🇹Lisbon, Portugal
Hospital Universitario Germans Trias i Pujol
🇪🇸Barcelona, Spain
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
MUC Research
🇩🇪Munich, Germany
North Manchester General Hospital
🇬🇧Manchester, United Kingdom
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
RIDU, Western General Hospital
🇬🇧Edinburgh, United Kingdom
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Klinikum der Universitat zu Koln
🇩🇪Koln, Germany
Medizinische Universitatsklinik Kiel
🇩🇪Kiel, Germany
Ospedale Luigi Sacco
🇮🇹Milan, Italy
Hospital Clinico San Cecilio
🇪🇸Granada, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Instituto de Investigacion Cientifica del Sur
🇵🇷Ponce, Puerto Rico
Hospital Doce De Octubre
🇪🇸Madrid, Spain
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
The Kinder Medical Group
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
David J. Shamblaw, MD Inc.
🇺🇸San Diego, California, United States
Duke University
🇺🇸Durham, North Carolina, United States
Metropolis Medical
🇺🇸San Francisco, California, United States
San Francisco VA Medical Center/UCSF
🇺🇸San Francisco, California, United States
Hawaii AIDS Clinical Research Program HACRP
🇺🇸Honolulu, Hawaii, United States
Universita' Cattolica Del Sacro Cuore
🇮🇹Rome, Italy
Southwest Center for HIV/AIDS
🇺🇸Phoenix, Arizona, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital Div of Infectious Disease
🇺🇸Detroit, Michigan, United States
University of Southern California, AIDS Clinical Trials Unit
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸Sacramento, California, United States
East Bay AIDS Center
🇺🇸Oakland, California, United States
Lifeway , Inc.
🇺🇸Fort Lauderdale, Florida, United States
Howard Brown Health Center
🇺🇸Chicago, Illinois, United States
South Florida Clinical Research
🇺🇸Atlantis, Florida, United States
Chatham County Health Department
🇺🇸Savannah, Georgia, United States
Atlanta ID Group
🇺🇸Atlanta, Georgia, United States
NorthPoint Medical
🇺🇸Fort Lauderdale, Florida, United States
Gordon E. Crofoot, MD, PA
🇺🇸Houston, Texas, United States
Therafirst Medical Centers
🇺🇸Fort Lauderdale, Florida, United States
Garcia Family Health Group
🇺🇸Harlingen, Texas, United States
Center for Special Immunology
🇺🇸Fountain Valley, California, United States
Tony Mills, MD Internal Medicine
🇺🇸Los Angeles, California, United States
Gary Richmond, MD, PA, Inc.
🇺🇸Fort Lauderdale, Florida, United States
The George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Mercer Univ. School of Medicine
🇺🇸Macon, Georgia, United States
University of Kentucky Healthcare/Bluegrass Care Clinic
🇺🇸Lexington, Kentucky, United States
STAR Health Care Center
🇺🇸Brooklyn, New York, United States
Albany Medical College
🇺🇸Albany, New York, United States
Brody School of Medicine at East Carolina University
🇺🇸Greenville, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Ground Zero Medical Centre
🇦🇺Darlinghurst, New South Wales, Australia
Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
EHS Pulmonary and Critical Care
🇺🇸Spokane, Washington, United States
St. Vincent's Hospital, Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
East Sidney Doctors
🇦🇺Sidney, New South Wales, Australia
Albion Street Centre
🇦🇺Sydney, New South Wales, Australia
CHU Bordeaux
🇫🇷Pessac, France
Hopital Tenon
🇫🇷Paris, France
Klinikum der J.W. Goethe-Universitat
🇩🇪Frankfurt, Germany
Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milan, Italy
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
🇮🇹Rome, Italy
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
VA Caribbean healthcare System
🇵🇷San Juan, Puerto Rico
University of Puerto Rico, School of Medicine, Proyecto ACTU
🇵🇷San Juan, Puerto Rico
Hospital General Universitario del Elche
🇪🇸Elche, Spain
Complexo Hospitalario Xeral-Cies (Chuvi) Vigo
🇪🇸Vigo, Spain
University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit
🇺🇸Chapel Hill, North Carolina, United States
Wohlfeiler, Piperato and Associates, LLC
🇺🇸North Miami Beach, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada