AzTrials
AzTrials

Human Immunodeficiency VirusPOEMNCT00665561

Prospective Observational Epidemiologic Study of Maraviroc's Safety

An observational study of Human Immunodeficiency Virus, run by ViiV Healthcare at 269 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Maraviroc along with an optimized background antiretroviral drug regimen and Optimized background antiretroviral drug regimen without maraviroc
How many people
2,500 participants
Where
269 sitesin 11 countries
Study dates
31 Mar 2008to 14 Feb 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Study population: Treatment experienced, HIV-1 infected patients in routine clinical practice.

Who may be able to join

  • Treatment experienced, HIV-1 infected patients
  • 18 years or older
  • Receive an approved assay for determination of HIV-1 tropism

Who cannot join

  • Pregnant or lactating
  • Using CCR5 inhibitor other than maraviroc

Trial locations and contacts

269 sites in 11 countries.

269 sites in 11 countries

United States145 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18102

  • University Of Michigan Health Systems

    Ann Arbor, Michigan, 48109

  • Atlanta Infectious Disease Group

    Atlanta, Georgia, 30309

  • Atlanta Primary Care

    Atlanta, Georgia, 30312

  • PMI Health Research Group

    Atlanta, Georgia, 30312

  • Family Health Care of Atlanta, PC

    Atlanta, Georgia, 30318

  • Absolute Care Medical Center

    Atlanta, Georgia, 30329

  • Kaiser Permanente

    Atlanta, Georgia, 30339-3915

  • Atlanta Specialty Research

    Atlanta, Georgia, 30342

  • Georgia Health Sciences University

    Augusta, Georgia, 30912

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Office of Franco Antonio Felizarta MD

    Bakersfield, California, 93301

  • Saint Hope Foundation

    Bellaire, Texas, 77401

  • ID Consultants Inc & Infectious Disease Research Corp.

    Boynton Beach, Florida, 33426

  • St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • Erie County Medical Center, HIV Services

    Buffalo, New York, 14215

  • Providence Clinical Research

    Burbank, California, 91505

  • Low Country Infectious Diseases, P.A.

    Charleston, South Carolina, 29414

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • MCC Clinic

    Columbia, South Carolina, 29203

  • University of South Carolina School of Medicine

    Columbia, South Carolina, 29203

  • University Speciality Clinics

    Columbia, South Carolina, 29203

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Southwest Infectious Disease Clinical Research, Inc.

    Dallas, Texas, 75219

  • UT Southwestern Medical Center HIV/AIDS Research Unit

    Dallas, Texas, 75235

  • Pillar Clinical Research LLC

    Dallas, Texas, 75243

  • Infectious Diseases Associates of Central Virginia

    Danville, Virginia, 24541

  • Daniel A. Warner/Consultive Medicine

    Daytona Beach, Florida, 32114

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Kaiser Permanente

    Denver, Colorado, 80205

  • National Jewish Health

    Denver, Colorado, 80206

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • The McGregor Clinic

    Fort Myers, Florida, 33901

  • Office of Allan Rowan Kelly MD

    Fort Worth, Texas, 76104

  • Tarrant County Infectious Disease Assocciates

    Fort Worth, Texas, 76104

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Lalla-Reddy Medical Corporation

    Fountain Valley, California, 92708

  • Associates in Infectious Disease

    Ft. Pierce, Florida, 34982

  • ID Associates

    Gastonia, North Carolina, 28054

  • East Carolina University

    Greenville, North Carolina, 27834

  • St. John hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Garcias' Family Health Group

    Harlingen, Texas, 78550

  • Valley Aids Council

    Harlingen, Texas, 78550

  • Pinnacle Health Medical Services

    Harrisburg, Pennsylvania, 17110

  • Health Services Center

    Hobson City, Alabama, 36201

  • Michael E. DeBakey Veterans Affairs Medical Center

    Houston, Texas, 77030

  • Diversified Medical Practices, PA

    Houston, Texas, 77057

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Marshall University Joan C. Edwards School of Medicine

    Huntington, West Virginia, 25701

  • AAC/Davis Clinic

    Huntsville, Alabama, 35801

  • Alabama Infectious Diseases Center

    Huntsville, Alabama, 35801

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Guthrie Medical Group

    Ithaca, New York, 14850

  • Duval County Health Department

    Jacksonville, Florida, 32206

  • Nemechek Health Renewal

    Kansas City, Missouri, 64111-2610

  • Kaiser Permanete of Colorado Rock Creek Medical Offices

    Lafayette, Colorado, 80026

  • Ingham County Health Department

    Lansing, Michigan, 48910

  • Michigan State University College of Osteopathic Medicine

    Lansing, Michigan, 48910

  • Blue Grass Care Clinic

    Lexington, Kentucky, 40536

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Bickerstaff Pediatric Family HIV Center

    Long Beach, California, 90806

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • LA Gay and Lesbian Center

    Los Angeles, California, 90028

  • Office of Peter J. Ruane, MD

    Los Angeles, California, 90036

  • Cedars Sinai Medical Group

    Los Angeles, California, 90048

  • Infectious Diseases Associates of Central Virginia

    Lynchburg, Virginia, 24501

  • North Shore University Hospital

    Manhasset, New York, 11030

  • WellStar Clinical Trials Office

    Marietta, Georgia, 30060

  • WellStar Infectious Disease

    Marietta, Georgia, 30060

  • WellStar Kennestone Hospital

    Marietta, Georgia, 30060

  • University of Miami

    Miami, Florida, 33136

  • Care Resource

    Miami, Florida, 33137

  • South Florida Infectious Deisease and Tropical Medicine Center

    Miami, Florida, 33176

  • Office of Albert Canas, MD

    Miami Beach, Florida, 33139

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07754

  • Meridian Medical Associates

    Neptune City, New Jersey, 07754

  • Yale University School of Medicine Aids Program

    New Haven, Connecticut, 06510

  • Clinical AIDS & HIV

    New Haven, Connecticut, 06511

  • Hospital of Saint Raphael

    New Haven, Connecticut, 06511

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70119

  • Beth Israel Medical Center

    New York, New York, 10003

  • Beth Israel Medical Clinic

    New York, New York, 10003

  • Mount Sinai Beth Israel Medical Center

    New York, New York, 10003

  • HIV & Internal Medicine

    New York, New York, 10011

  • Mount Sinai Downtown Comprehensive Health Program

    New York, New York, 10011

  • Columbia University Medical Center

    New York, New York, 10032

  • CUMC Research Pharmacy

    New York, New York, 10032

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Circle Medical, LLC

    Norwalk, Connecticut, 06851

  • Alta Bates Summit Medical Center East Bay AIDS Center

    Oakland, California, 95035

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Office of William Johnson, M.D.

    Olympia Fields, Illinois, 60461

  • Southside Health Association

    Olympia Fields, Illinois, 60461

  • University of California Irvine Medical Center

    Orange, California, 92868

  • A Professional Corporation, Research Department

    Palm Desert, California, 92211

  • Stanford ACTG

    Palo Alto, California, 94304-5350

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-6073

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Philadelphia Fight

    Philadelphia, Pennsylvania, 19107

  • Dr. Howard Kussman, MD

    Plano, Texas, 75075

  • The Research and Education Group

    Portland, Oregon, 97210

  • Kaiser Permanente Northwest Region, Immune Deficiency Clinic

    Portland, Oregon, 97227

  • Infectious Diseases Associates

    Riverdale, Georgia, 30274

  • Federal Medical Center Rochester

    Rochester, Minnesota, 55904

  • Mayo Medical Clinic

    Rochester, Minnesota, 55905

  • AIDS Care

    Rochester, New York, 14607

  • University of California

    Sacramento, California, 95817

  • Health Positive

    Safety Harbor, Florida, 34695

  • University Health Care System

    San Antonio, Texas, 78207

  • South Texas Veterans Health Care System

    San Antonio, Texas, 78229

  • Kaiser Permanente Medical Center

    San Francisco, California, 94118

  • San Francisco Veterans Affairs Medical Center

    San Francisco, California, 94121

  • Chatham County Health Department

    Savannah, Georgia, 31401

  • Guthrie Clinic, Ltd.

    Sayre, Pennsylvania, 18840

  • Group Health Cooperative

    Seattle, Washington, 98112

  • Montgomery Infectious Disease Associates, P.A. (Private Practice)

    Silver Spring, Maryland, 20910

  • Newland Medical Associates

    Southfield, Michigan, 48075

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • The Research Institute

    Springfield, Massachusetts, 01107

  • Baystate Infectious Diseases Clinical Research

    Springfield, Massachusetts, 01199

  • Central West Clinical Research

    St Louis, Missouri, 63108

  • Pinellas Care Clinic

    St. Petersburg, Florida, 33713

  • Statnford University Medical Center

    Stanford, California, 94305

  • Infectious Disease Research Institute, Inc

    Tampa, Florida, 33614

  • Midtown Medical Center

    Tampa, Florida, 33614

  • St. Joseph's Hospital Comprehensive Research Institute

    Tampa, Florida, 33614

  • Tampa Care Clinic

    Tampa, Florida, 33614

  • University of Toledo: Health Sciences Campus

    Toledo, Ohio, 43614

  • New York Medical College

    Valhalla, New York, 10595

  • Westchester Medical Center

    Valhalla, New York, 10595

  • Bipin Bhagat MD Inc.

    Victorville, California, 92395

  • Dupont Circle Physician's Group

    Washington D.C., District of Columbia, 20009

  • Family Medical Counseling Service

    Washington D.C., District of Columbia, 20020

  • Division of Infectious Diseases, George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • George Washington University Medical Faculty Assoc

    Washington D.C., District of Columbia, 20037

  • Office of Mahmoud H. Mustafa, MD, FACP

    Washington D.C., District of Columbia, 20037

  • Rowan Tree Medical, PA

    Wilton Manors, Florida, 33305

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain26 sites

  • Complejo Hospitalario Juan Canalejo

    A Coruña, 15006

  • Hospital General Universitário de Alicante

    Alicante, 03010

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Germans Tias I Pujol

    Barcelona, 08916

  • Unidad de Enfermedades Infecciosas

    Cadiz, 11009

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • Hospital General Universitario de Elche

    Elche, 03203

  • Hospital Clinico San Cecilio

    Granada, 18012

  • Hospital San Pedro

    Logroño, La Rioja, 26006

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Carlos Iii

    Madrid, 28029

  • Hospital Ramon Y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Univ. La Paz

    Madrid, 28046

  • Hospital de Mostoles

    Madrid, 28935

  • Complejo Hospitalario Carlos Haya

    Málaga, 29010

  • Mataro Hospital

    Mataró, 08304

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Universitario Virgen de La Macarena

    Seville, 41009

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Clinica Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital de Tortosa Verge de La Cinta

    Tortosa, Tarragona, 43500

  • Hospital Clinico Universitario

    Valencia, 46010

Other trials in Spain

Italy23 sites

  • Clinica Malattie Infettive

    Bari, 70124

  • Ambulatorio Day Hospital Malattie Infettive

    Bologna, 40133

  • Dipartimento di Medicina Clinica Specialistica e Sperimentale

    Bologna, 40138

  • Busto Arsizio Hospital

    Busto Arsizio, 21052

  • SOD Malattie Infettive, La Piastra dei Servizi

    Florence, 50139

  • Ente Ospedaliero Ospedali Galliera

    Genova, 16128

  • San Raffaele Hospital

    Milan, 20127

  • Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital

    Milan, 20142

  • 1 Divisione di Malattive Infettive e Servizio di Allergologia, Ospedale L. Sacco

    Milan, 20157

  • Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco

    Milan, 20157

  • Azienda Ospedaliero Universitaria Policlinico di Modena

    Modena, 41100

  • Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia

    Naples, 80135

  • Azienda Ospedaliera "Domenico Cotugno"

    Naples, 80137

  • AOUP Paolo Giaccone, UOC Malattie Infettive

    Palermo, 90127

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero

    Pescara, 65100

  • Istituto Nazionale Malattie Infettive "L.Spallanzani"-IRCCS

    Roma, 00149

  • Istituto Nazionale Malattie Infettive INMI- "L. Spallanzani"- I.R.C.C.S.

    Roma, 00149

  • Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive e Tropicali

    Roma, 00161

  • Universita'Cattolica del Sacro Cuore Policlinico Gemelli

    Roma, 00168

  • Azienda Ospedaliera San Giovanni Addolorata Presidia Santa Maria

    Rome, 00184

  • Ospedale Amedeo di Savoia

    Torino, 10100

  • Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive

    Torino, 10149

Other trials in Italy

Germany20 sites

  • Arztpraxis fuer Innere Medizin Dr. Knechten

    Aachen, 52062

  • Praxis City Ost Medizinisches Zentrum

    Berlin, 10243

  • Praxis Dr. Christiane Cordes

    Berlin, D-10243

  • Klinik I fuer Innere Medizin der Uni-Klinik Koeln

    Cologne, D-50937

  • Klinikum Dortmund

    Dortmund, 44137

  • Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie

    Dresden, D-01307

  • Hospital of the J.W. Goethe University, Medical Clinic II

    Frankfurt am Main, D-60590

  • Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt

    Fürth, 90762

  • IPM - Study - Center

    Hamburg, 20146

  • ifi-Institut am Allgemeines Krankenhaus St.Georg

    Hamburg, D-20099

  • Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

    Hamburg, D-20246

  • Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik,

    Mainz, D-55131

  • Mannheimer Onkologie Praxis

    Mannheim, D-68161

  • Gemeinschaftspraxis Untersendling

    München, 81371

  • Medizinisches Versorgungszentrum

    München, D 80335

  • Ludwig-Maximilians-Universitaet, Klinikum Innenstadt, Medizinische Poliklinik

    München, D-80336

  • Centrum fuer interdisziplinaere Medizin Muenster GmbH

    Münster, 48143

  • Klinikum Osnabruck

    Osnabrück, D-49090

  • Infectomed GbR Zentrum für medizinische Studien

    Stuttgart, D-70197

  • Privatpraxis Ulmer, Frietsch, Müller

    Stuttgart, D-70197

Other trials in Germany

United Kingdom17 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • Selly Oak Hospital

    Birmingham, B4 6DH

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 1ES

  • Hull & East Yorkshire Hospitals NHS Trust

    Cottingham, EAST Yorkshire, HU16 5JQ

  • North Manchester General Hospital

    Crumpsall, M8 5RB

  • Darlington Memorial Hospital

    Darlington, DL36HX

  • Regional Infectious Diseases Unit

    Edinburgh, EH4 2XU

  • Grahame Hayton Unit

    London, E1 1BB

  • North Middlesex Hospital

    London, N18 1QX

  • Royal Free Hospital, Ian Charleson Day Centre

    London, NW3 2QG

  • 1st Floor St Stephens Centre

    London, SW10 9NH

  • Clinical Resource Building, Level 7

    Newcastle upon Tyne, Newcastle, NE1 4LP

  • Royal Victoria Infirmary Hospital

    Newcastle upon Tyne, NE1 4LP

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Warren browne Unit, Southlands Hospital

    Shoreham-by-Sea, BN43 6TQ

  • Cobridge Community Health Centre

    Stoke-on-Trent, ST6 2JW

  • St. George's Hospital

    Tooting, SW17 0QT

Other trials in United Kingdom

France15 sites

  • Hopital Jean Verdier, Unite de maladies infectieuses

    Bondy, 93140

  • Hopital Saint-andre CHU de Bordeaux

    Bordeaux, 33075

  • Hopital Pellegrin

    Bordeaux, 33076

  • Raymond Poincare Hospital

    Garches, 92380

  • Hopital de L'Hotel Dieu

    Lyon, 69288

  • Hopital Sainte Marguerite

    Marseille, 13274

  • Saint-Louis Hospital

    Paris, 75010

  • Cochin Hospital Saint Vincent de Paul

    Paris, 75014

  • Hopital Tenon

    Paris, 75020

  • Hopital Pitie Salpetriere

    Paris, 75651

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • CH Perpignan

    Perpignan, 66000

  • Hôpital Haut - Leveque - Centre Francois Magendie

    Pessac, 33604

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033 Cedex 09

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208

Other trials in France

Canada7 sites

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • Clinique Medicale du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • CHUM, Hotel-Dieu Hospital

    Montreal, Quebec, H2W 1T8

  • Recherche Clinique Médicale des Campus

    Québec, Quebec, G1V 4X7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network

    Toronto, Ontario, M5G 2N2

  • University of British Columbia/ Downtown Infectious Diseases Clinic

    Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

Brazil6 sites

  • Hospital Dia

    Brasília, Federal District, 70351-580

  • Instituto A.Z. de Pesquisa e Ensino

    Curitiba, Paraná, 80240-280

  • Hospital Geral de Nova Iguacu

    Nova Iguaçu, Rio de Janeiro, 26030-380

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Centro de Referencia e Treinamento DST/AIDS

    São Paulo, São Paulo, 04121-000

  • Hospital Heliopolis

    São Paulo, São Paulo, 04231-030

Other trials in Brazil

Belgium5 sites

  • Institute of Tropical Medicine

    Antwerp, B-2000

  • CHU Saint Pierre

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde

    Leuven, B-3000

  • C.H.U. Sart-Tilman

    Liège, 4000

Other trials in Belgium

Greece3 sites

  • Andreas Syngros Hospital

    Athens, 161 21

  • University Hospital of Patras

    Pátrai, Achaia, 26 500

  • Tzaneion General Hospital of Piraeus

    Piraeus, 185 36

Other trials in Greece

Puerto Rico2 sites

  • Ararat Research Center

    Ponce, PR, 00717-1567

  • HOPE Clinical Research

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS

The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

Read the detailed description

All patients meeting the study eligibility criteria at participating sites will be invited to participate.

Being tested
Maraviroc along with an optimized background antiretroviral drug regimen, Optimized background antiretroviral drug regimen without maraviroc
Keywords
Maraviroc, HIV-1, Safety, Non-interventional
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

  • Maraviroc along with an optimized background antiretroviral drug regimenDrug

    Also called Selzentry, Celsentri

    Maraviroc prescribed per approved local label.

  • Optimized background antiretroviral drug regimen without maravirocDrug

    Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Study groups in NCT00665561
Study groupRoleWhat they receive
Maraviroc exposedNot described
Receives: Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc unexposedNot described
Receives: Drug: Optimized background antiretroviral drug regimen without maraviroc

What is being measured

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

  1. Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections

    Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).

    Measured: Up to 5 years following enrollment

  2. Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis

    Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    Measured: Up to 5 years following enrollment

  3. Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)

    Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    Measured: Up to 5 years following enrollment

  4. Density Rate Per 1000 Participant-Years for Incidence of Liver Failure

    Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    Measured: Up to 5 years following enrollment

  5. Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'

    Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.

    Measured: Up to 5 years following enrollment

  6. Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'

    Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.

    Measured: Up to 5 years following enrollment

  7. Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis

    Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    Measured: Up to 5 years following enrollment

  8. Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause

    Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    Measured: Up to 5 years following enrollment

  9. Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause

    Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    Measured: Up to 5 years following enrollment

  10. Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections

    Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.

    Measured: Up to 5 years following enrollment

  11. Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)

    Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.

    Measured: Up to 5 years following enrollment

  12. Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'

    Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.

    Measured: Up to 5 years following enrollment

  13. Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'

    Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.

    Measured: Up to 5 years following enrollment

  14. Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause

    Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.

    Measured: Up to 5 years following enrollment

  15. Percentage of Participants With All-Cause Mortality

    All-cause death was defined as the death due to any cause during the course of study.

    Measured: Up to 5 years following enrollment

Timeline

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

  1. First posted24 Apr 2008 (estimated)
  2. Study start31 Mar 2008
  3. Primary completion14 Feb 2019
  4. Study completion14 Feb 2019

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00665561
Sponsor's protocol ID
A4001067
Other IDs
2007-006148-24, POEM
Acronym
POEM
Status last verified
Oct 2022
First submitted
23 Apr 2008
Last updated
18 Oct 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus, run by ViiV Healthcare at 269 sites in 11 countries.

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

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 269 sites in United States, Spain, Italy, Germany, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections (time frame: Up to 5 years following enrollment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00665561.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.

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