Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
- Conditions
- HIV-1
- Interventions
- Drug: Emtricitabine/tenofovirDrug: placebo for emtricitabine/tenofovirDrug: darunavir/ritonavir 800/100 mg
- Registration Number
- NCT01345630
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.
- Detailed Description
The study was terminated on October 8, 2013 following a preliminary review of the Week 48 primary efficacy data by the study's external independent Data Monitoring Committee (DMC). The DMC assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures. The DMC recommended and the Sponsor concurred that the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to the comparator arm (Emtricitabine/Tenofovir).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 813
- Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit.
- CD4 count equal to or greater than 100 cells/mm3 at Screening.
- Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.
- Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
- Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.
- CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Emtricitabine/tenofovir placebo for emtricitabine/tenofovir Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Maraviroc placebo for maraviroc Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Emtricitabine/tenofovir Emtricitabine/tenofovir Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Maraviroc darunavir/ritonavir 800/100 mg Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Maraviroc Maraviroc Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL. Week 48 The proportion of participants who achieved HIV-1 RNA \<50 copies/mL at week 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.
- Secondary Outcome Measures
Name Time Method Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48 Baseline, Week 48 The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared.
Frequency of Adverse Events (AE). Week 96 Number of participants with treatment-emergent non serious AEs
Number of Participants With Grade 3 or 4 AEs Week 96 Number of participants with grade 3 or 4 AEs are presented here.
The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA). Week 48 The relationship of the proportion of participants achieving HIV-1 RNA \<50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA's Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA \<50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (\<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method.
Number of Participants With Abnormal Laboratory Values Week 96 Number of participants with laboratory abnormalities are reported
Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF). Week 48 Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA \<1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is \<50 copies/mL, or • Plasma HIV-1 RNA \>1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to \<50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is \<400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is \<50 copies/mL (before August 30 2012) or \<400 copies/mL (after August 30 2012).
Number of Treatment-related AEs Week 96 Number of treatment-related AEs are presented here.
Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria. Week 48 For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism.
Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria Week 48 For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI's were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm.
Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%) Baseline, Week 48 The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3) Baseline, Week 48 The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
Number of Participants Who Discontinued Due to AEs Week 96 Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants.
Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48. Week 48 A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD Week 48 Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan.
Number of Participants With Treatment-emergent Serious Adverse Events Week 96 Total number of participants with treatment-emergent serious adverse events are reported
Severity of Abnormal Laboratory Values Week 96 Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant.
Tropism Change Between Screening or Baseline and PDTF Week 48 For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF.
Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3) Baseline, Week 48 The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD Week 48 Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan.
Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%) Baseline, Week 48 The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.
Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48 Week 48 A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.
Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1) Week 48 Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study.
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD Week 48 Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan.
Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin Week 48 Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study.
Trial Locations
- Locations (174)
Circle CARE Center
🇺🇸Norwalk, Connecticut, United States
CHU de Nantes - Hotel Dieu
🇫🇷Nantes, France
Health Services Center
🇺🇸Hobson City, Alabama, United States
Wohlfeiler, Piperato and Associates, LLC
🇺🇸Miami Beach, Florida, United States
Infectious Diseases Associates of Northwest Florida, PA
🇺🇸Pensacola, Florida, United States
Kaiser Permanente
🇺🇸Union City, California, United States
Holdsworth House General Practice
🇦🇺Darlinghurst, New South Wales, Australia
Brisbane Sexual Health and HIV Service
🇦🇺Brisbane, Queensland, Australia
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
East Sydney Doctors
🇦🇺Darlinghurst, New South Wales, Australia
DeKalb Medical Diagnostic Breast Center
🇺🇸Decatur, Georgia, United States
Instituut voor Tropische Geneeskunde
🇧🇪Antwerpen, Belgium
Melbourne Sexual Health Centre
🇦🇺Carlton, Victoria, Australia
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
North Texas Infectious Diseases Consultants, PA
🇺🇸Dallas, Texas, United States
University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease
🇺🇸Iowa City, Iowa, United States
AKH Wien Universitaetsklinik fuer Dermatologie
🇦🇹Wien, Austria
Taylor Square Private Clinic
🇦🇺Surry Hills, New South Wales, Australia
Biomedical and Health Institutional Review Board
🇺🇸East Lansing, Michigan, United States
Hopital Henri Mondor
🇫🇷Creteil, France
Be Well Medical Center, PC
🇺🇸Berkley, Michigan, United States
Hopital Bicetre
🇫🇷Le Kremlin Bicetre, France
Howard Brown Health Center
🇺🇸Chicago, Illinois, United States
St Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Maple Leaf Research / Maple Leaf Medical Clinic
🇨🇦Toronto, Ontario, Canada
CHR d'Orleans la Source
🇫🇷Orleans, Cedex 02, France
Hopital Saint Antoine
🇫🇷Paris, Cedex 12, France
Sodersjukhuset, Venhalsan
🇸🇪Stockholm, Sweden
Hôpital de la Pitié Salpétrière
🇫🇷Paris, France
Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza
🇵🇱Bydgoszcz, Poland
Cliniques Universitaires St-Luc
🇧🇪Brussels, Belgium
Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs
🇫🇮Helsinki, Finland
The Ottawa Hospital-Riverside Campus
🇨🇦Ottawa, Ontario, Canada
Hopital Gui de Chauliac
🇫🇷Montpellier, France
Hopital Saint-Louis
🇫🇷Paris Cedex 10, France
Karolinska Universitetssjukhuset Huddinge
🇸🇪Stockholm, Sweden
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,
🇬🇧London, United Kingdom
Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals
🇬🇧Manchester, United Kingdom
Hopital de la Croix Rousse
🇫🇷LYON Cedex 4, France
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
University Health Network / Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Universitaetsspital Basel Infektiologie und Spitalhygiene
🇨🇭Basel, Switzerland
Hopital Saint-andre
🇫🇷Bordeaux cedex, France
Dept of Sexual Health & HIV Medicine
🇬🇧Birmingham, United Kingdom
Regional Infectious Diseases Unit
🇬🇧Edinburgh, United Kingdom
Hospital Universitario Virgen de la Macarena
🇪🇸Sevilla, Spain
EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
🇩🇪Berlin, Germany
ICH - Study - Center GmbH & Co. KG
🇩🇪Hamburg, Germany
Hopital Bichat
🇫🇷Paris, Cedex 18, France
HIV Research Department, Elton John Centre
🇬🇧Brighton, United Kingdom
Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt
🇩🇪Muenchen, Germany
Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II
🇩🇪Frankfurt am Main, Germany
Centre for Sexual Health & HIV Research, University College London
🇬🇧London, United Kingdom
Nouvel Hopital Civil
🇫🇷Strasbourg Cedex, France
Universitaetsklinikum Bonn, Immunologische Ambulanz HIV
🇩🇪Bonn, Germany
MUC Research Group GbR
🇩🇪Muenchen, Germany
InfektioResearch GmbH & Co. KG
🇩🇪Frankfurt am Main, Germany
Ian Charleson Day Centre, Royal Free Hospital
🇬🇧London, United Kingdom
Northwestern University/NMH
🇺🇸Chicago, Illinois, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Community AIDS Resource Inc dba Care Resource
🇺🇸Miami, Florida, United States
The Kinder Medical Group
🇺🇸Miami, Florida, United States
UMHC/Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
University of Miami AIDS Clinical Research Unit
🇺🇸Miami, Florida, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Dr. Anthony Mills, MD, Inc.
🇺🇸Los Angeles, California, United States
Orange Coast Medical Group
🇺🇸Newport Beach, California, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Kaiser Permanente Santa Clara
🇺🇸Santa Clara, California, United States
Broward Health - Comprehensive Care Center
🇺🇸Fort Lauderdale, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Rowan Tree Medical, PA
🇺🇸Wilton Manors, Florida, United States
Michigan State University College of Osteopathic Medicine - Department of Internal Medicine
🇺🇸East Lansing, Michigan, United States
Ingham County Health Department
🇺🇸Lansing, Michigan, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Brandywine Common
🇺🇸Neptune, New Jersey, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States
Beth Israel Medical Center - AIDS Clinical Trials Unit
🇺🇸New York, New York, United States
AIDS Community Research Initiative of America (ACRIA)
🇺🇸New York, New York, United States
Dr. Howard A. Grossman, M.D.
🇺🇸New York, New York, United States
Research Across America
🇺🇸New York, New York, United States
AIDS Care
🇺🇸Rochester, New York, United States
I.D. Consultants, P.A.
🇺🇸Charlotte, North Carolina, United States
The University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
(DEXA Scan Facility) East Carolina University Brody Outpatient Center
🇺🇸Greenville, North Carolina, United States
East Carolina University Division of Infectious Diseases
🇺🇸Greenville, North Carolina, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
Clinique Medicale L'Actuel
🇨🇦Montreal, Quebec, Canada
Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
🇩🇪Koeln, Germany
Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
🇭🇺Budapest, Hungary
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
SPZOZ Wojewodzki Szpital Zakazny
🇵🇱Warszawa, Poland
Hospital Sta. Maria
🇵🇹Lisboa, Portugal
Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos
🇵🇹Lisboa, Portugal
Innovative Care PSC
🇵🇷Bayamon, Puerto Rico
Ararat Research Center
🇵🇷Ponce, Puerto Rico
Hospital São João
🇵🇹Porto, Portugal
HOPE Clinical Research
🇵🇷San Juan, Puerto Rico
University of Puerto Rico Medical Sciences Campus
🇵🇷Rio Piedras, Puerto Rico
Hospital Universitari de Bellvitge
🇪🇸L´hospitalet de Llobregat, Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia - Hospital Provincial
🇪🇸Cordoba, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario de La Paz
🇪🇸Madrid, Spain
Synarc Inc.
🇺🇸San Francisco, California, United States
Investigational Drugs Pharmacy
🇺🇸San Francisco, California, United States
Kaiser Permanente - Clinical Trials Unit
🇺🇸San Francisco, California, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Cincinnati - Department of Internal Medicine
🇺🇸Cincinnati, Ohio, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Hvidovre Hospital, Infektionsmedicinsk afd.
🇩🇰Hvidovre, Denmark
Rigshospitalet, Epidemiklinikken
🇩🇰Koebenhavn OE, Denmark
Odense Universitetshospital
🇩🇰Odense, Denmark
Ospedale San Raffaele
🇮🇹Milano, Italy
University of Alabama at Birmingham - 1917 Research Clinic
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente of Colorado
🇺🇸Denver, Colorado, United States
University Physicians Group
🇺🇸Detroit, Michigan, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Centre Hospitalier de Tourcoing
🇫🇷Tourcoing, France
SU Ostra sjukhuset, Infektionsmottagningen
🇸🇪Goteborg, Sweden
Skanes Universitetssjukhus
🇸🇪Malmo, Sweden
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Therapeutic Concepts, PA
🇺🇸Houston, Texas, United States
Research Access Network
🇺🇸Houston, Texas, United States
The Office of Dr. Gordon E. Crofoot, M.D., PA
🇺🇸Houston, Texas, United States
Hopital Tenon, Service des Maladies Infectieuses
🇫🇷Paris, France
Queen Elizabeth Hospital
🇬🇧London, United Kingdom
Praxis Christiane Cordes
🇩🇪Berlin, Germany
Studiengesellschaft mbH Gubener 37
🇩🇪Berlin, Germany
St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
ifi - Studien und Projekte GmbH
🇩🇪Hamburg, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Hôpital Universitaire Erasme
🇧🇪Bruxelles, Belgium
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej
🇵🇱Wroclaw, Poland
Medical Center University Hospital
🇵🇷Rio Piedras, Puerto Rico
C.H.U. St-Pierre
🇧🇪Brussels, Belgium
C.H.U. Sart-Tilman
🇧🇪Liege, Belgium
Clinique Medicale du Quartier Latin
🇨🇦Montreal, Quebec, Canada
Inselspital Universitaetsklinik fuer Infektiologie
🇨🇭Bern, Switzerland
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Clinical Research Unit, Infectious Diseases
🇦🇺Melbourne, Victoria, Australia
Hospital Prof. Doutor Fernando Fonseca E.P.E.
🇵🇹Amadora, Portugal
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
Vancouver ID Research and Care Centre Society
🇨🇦Vancouver, British Columbia, Canada
Baystate Infectious Diseases Clinical Research
🇺🇸Springfield, Massachusetts, United States
Capital Medical Associates, PC
🇺🇸Washington, District of Columbia, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
University of California Davis Research
🇺🇸Sacramento, California, United States
TICON I Research Clinic (DEXA Scan only)
🇺🇸Sacramento, California, United States
Kaiser Hospital Sacramento
🇺🇸Sacramento, California, United States
University of Colorado Denver - University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Yale - New Haven Hospital Nathan Smith Clinic
🇺🇸New Haven, Connecticut, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Infectious Disease Research Institute, Inc.
🇺🇸Tampa, Florida, United States
Osteoporosis Care Center
🇺🇸Tampa, Florida, United States
Quest Diagnostic Laboratory
🇺🇸Tampa, Florida, United States
St. Joseph's Hospital Diagnostic Center
🇺🇸Tampa, Florida, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
University of South Florida Health-HIV Clinical Research Unit
🇺🇸Tampa, Florida, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Kansas City Free Health Clinic
🇺🇸Kansas City, Missouri, United States