Prospective Observational Epidemiologic Study of Maraviroc's Safety

Human Immunodeficiency Virus Clinical Trial

— POEM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665561
• Other study ID #: A4001067
• Secondary ID: 2007-006148-24PO
• Status: Completed
• Start date: March 31, 2008
• Est. completion date: February 14, 2019

Study information

• Verified date: October 2022
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: February 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treatment experienced, HIV-1 infected patients

• 18 years or older

• Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria:

• Pregnant or lactating

• Using CCR5 inhibitor other than maraviroc

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Drug:
• Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
• Optimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerpen
Belgium	CHU Saint Pierre	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde	Leuven
Belgium	C.H.U. Sart-Tilman	Liege
Brazil	Hospital Dia	Brasilia	DF
Brazil	Instituto A.Z. de Pesquisa e Ensino	Curitiba	Parana
Brazil	Hospital Geral de Nova Iguacu	Nova Iguacu	RJ
Brazil	Faculdade de Medicina do ABC	Santo André	SP
Brazil	Centro de Referencia e Treinamento DST/AIDS	Sao Paulo	SP
Brazil	Hospital Heliopolis	São Paulo	SP
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	CHUM, Hotel-Dieu Hospital	Montreal	Quebec
Canada	Clinique Medicale du Quartier Latin	Montreal	Quebec
Canada	Recherche Clinique Médicale des Campus	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	University of British Columbia/ Downtown Infectious Diseases Clinic	Vancouver	British Columbia
France	Hopital Jean Verdier, Unite de maladies infectieuses	Bondy
France	Hopital Pellegrin	Bordeaux
France	Hopital Saint-andre CHU de Bordeaux	Bordeaux
France	Raymond Poincare Hospital	Garches
France	Hopital de L'Hotel Dieu	Lyon
France	Hopital Sainte Marguerite	Marseille Cedex 09
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Pitie Salpetriere	Paris
France	Hopital Tenon	Paris
France	Saint-Louis Hospital	Paris
France	Cochin Hospital Saint Vincent de Paul	Paris Cedex 14
France	CH Perpignan	Perpignan
France	Hôpital Haut - Leveque - Centre Francois Magendie	PESSAC Cedex
France	Centre Hospitalier Universitaire de Rennes	Rennes
France	Centre Hospitalier de Tourcoing	Tourcoing
Germany	Arztpraxis fuer Innere Medizin Dr. Knechten	Aachen
Germany	Praxis City Ost Medizinisches Zentrum	Berlin
Germany	Praxis Dr. Christiane Cordes	Berlin
Germany	Klinikum Dortmund	Dortmund
Germany	Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie	Dresden
Germany	Hospital of the J.W. Goethe University, Medical Clinic II	Frankfurt am Main
Germany	Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt	Fuerth
Germany	ifi-Institut am Allgemeines Krankenhaus St.Georg	Hamburg
Germany	IPM - Study - Center	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie	Hamburg
Germany	Klinik I fuer Innere Medizin der Uni-Klinik Koeln	Koeln
Germany	Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik,	Mainz
Germany	Mannheimer Onkologie Praxis	Mannheim
Germany	Gemeinschaftspraxis Untersendling	Muenchen
Germany	Ludwig-Maximilians-Universitaet, Klinikum Innenstadt, Medizinische Poliklinik	Muenchen
Germany	Medizinisches Versorgungszentrum	Muenchen
Germany	Centrum fuer interdisziplinaere Medizin Muenster GmbH	Muenster
Germany	Klinikum Osnabruck	Osnabruck
Germany	Infectomed GbR Zentrum für medizinische Studien	Stuttgart
Germany	Privatpraxis Ulmer, Frietsch, Müller	Stuttgart
Greece	Andreas Syngros Hospital	Athens
Greece	University Hospital of Patras	Patras	Achaia
Greece	Tzaneion General Hospital of Piraeus	Piraeus
Italy	Clinica Malattie Infettive	Bari
Italy	Ambulatorio Day Hospital Malattie Infettive	Bologna
Italy	Dipartimento di Medicina Clinica Specialistica e Sperimentale	Bologna
Italy	Busto Arsizio Hospital	Busto Arsizio
Italy	SOD Malattie Infettive, La Piastra dei Servizi	Firenze
Italy	Ente Ospedaliero Ospedali Galliera	Genova
Italy	Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital	Milan
Italy	San Raffaele Hospital	Milan
Italy	1 Divisione di Malattive Infettive e Servizio di Allergologia, Ospedale L. Sacco	Milano
Italy	Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco	Milano
Italy	Azienda Ospedaliero Universitaria Policlinico di Modena	Modena
Italy	Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia	Naples
Italy	Azienda Ospedaliera "Domenico Cotugno"	Napoli
Italy	AOUP Paolo Giaccone, UOC Malattie Infettive	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero	Pescara
Italy	Istituto Nazionale Malattie Infettive "L.Spallanzani"-IRCCS	Roma
Italy	Istituto Nazionale Malattie Infettive INMI- "L. Spallanzani"- I.R.C.C.S.	Roma
Italy	Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive e Tropicali	Roma
Italy	Universita'Cattolica del Sacro Cuore Policlinico Gemelli	Roma
Italy	Azienda Ospedaliera San Giovanni Addolorata Presidia Santa Maria	Rome
Italy	Ospedale Amedeo di Savoia	Torino
Italy	Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive	Torino
Puerto Rico	Ararat Research Center	Ponce
Puerto Rico	HOPE Clinical Research	San Juan
Spain	Complejo Hospitalario Juan Canalejo	A Coruña
Spain	Hospital General Universitário de Alicante	Alicante
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitario Germans Tias I Pujol	Barcelona
Spain	Unidad de Enfermedades Infecciosas	Cadiz
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital General Universitario de Elche	Elche
Spain	Hospital Clinico San Cecilio	Granada
Spain	Hospital San Pedro	Logroño	LA Rioja
Spain	Hospital Carlos Iii	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital de Mostoles	Madrid
Spain	Hospital Ramon Y Cajal	Madrid
Spain	Hospital Univ. La Paz	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Complejo Hospitalario Carlos Haya	Malaga
Spain	Mataro Hospital	Mataro
Spain	Hospital Donostia	San Sebastian
Spain	Hospital Universitario Virgen de La Macarena	Sevilla
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Clinica Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital de Tortosa Verge de La Cinta	Tortosa	Tarragona
Spain	Hospital Clinico Universitario	Valencia
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Selly Oak Hospital	Birmingham
United Kingdom	Brighton and Sussex University Hospitals NHS Trust	Brighton
United Kingdom	Hull & East Yorkshire Hospitals NHS Trust	Cottingham	EAST Yorkshire
United Kingdom	North Manchester General Hospital	Crumpsall
United Kingdom	Darlington Memorial Hospital	Darlington
United Kingdom	Regional Infectious Diseases Unit	Edinburgh
United Kingdom	1st Floor St Stephens Centre	London
United Kingdom	Grahame Hayton Unit	London
United Kingdom	North Middlesex Hospital	London
United Kingdom	Royal Free Hospital, Ian Charleson Day Centre	London
United Kingdom	Clinical Resource Building, Level 7	Newcastle upon Tyne	Newcastle
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Royal Victoria Infirmary Hospital	Newcastle Upon Tyne
United Kingdom	Warren browne Unit, Southlands Hospital	Shoreham-by-Sea
United Kingdom	Cobridge Community Health Centre	Stoke-on-Trent
United Kingdom	St. George's Hospital	Tooting
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University Of Michigan Health Systems	Ann Arbor	Michigan
United States	Absolute Care Medical Center	Atlanta	Georgia
United States	Atlanta Infectious Disease Group	Atlanta	Georgia
United States	Atlanta Primary Care	Atlanta	Georgia
United States	Atlanta Specialty Research	Atlanta	Georgia
United States	Family Health Care of Atlanta, PC	Atlanta	Georgia
United States	Kaiser Permanente	Atlanta	Georgia
United States	PMI Health Research Group	Atlanta	Georgia
United States	Georgia Health Sciences University	Augusta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	Office of Franco Antonio Felizarta MD	Bakersfield	California
United States	Saint Hope Foundation	Bellaire	Texas
United States	ID Consultants Inc & Infectious Disease Research Corp.	Boynton Beach	Florida
United States	St. Elizabeth's Medical Center	Brighton	Massachusetts
United States	Erie County Medical Center, HIV Services	Buffalo	New York
United States	Providence Clinical Research	Burbank	California
United States	Low Country Infectious Diseases, P.A.	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Howard Brown Health Center	Chicago	Illinois
United States	Ruth M. Rothstein CORE Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	MCC Clinic	Columbia	South Carolina
United States	University of South Carolina School of Medicine	Columbia	South Carolina
United States	University Speciality Clinics	Columbia	South Carolina
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Dallas VA Medical Center	Dallas	Texas
United States	Pillar Clinical Research LLC	Dallas	Texas
United States	Southwest Infectious Disease Clinical Research, Inc.	Dallas	Texas
United States	UT Southwestern Medical Center HIV/AIDS Research Unit	Dallas	Texas
United States	Infectious Diseases Associates of Central Virginia	Danville	Virginia
United States	Daniel A. Warner/Consultive Medicine	Daytona Beach	Florida
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Kaiser Permanente	Denver	Colorado
United States	National Jewish Health	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	The McGregor Clinic	Fort Myers	Florida
United States	Associates in Infectious Disease	Fort Pierce	Florida
United States	Office of Allan Rowan Kelly MD	Fort Worth	Texas
United States	Tarrant County Infectious Disease Assocciates	Fort Worth	Texas
United States	Tarrant County Infectious Disease Associates	Fort Worth	Texas
United States	Lalla-Reddy Medical Corporation	Fountain Valley	California
United States	ID Associates	Gastonia	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	St. John hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Garcias' Family Health Group	Harlingen	Texas
United States	Valley Aids Council	Harlingen	Texas
United States	Pinnacle Health Medical Services	Harrisburg	Pennsylvania
United States	Health Services Center	Hobson City	Alabama
United States	Diversified Medical Practices, PA	Houston	Texas
United States	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas
United States	Rosedale Infectious Diseases	Huntersville	North Carolina
United States	Marshall University Joan C. Edwards School of Medicine	Huntington	West Virginia
United States	AAC/Davis Clinic	Huntsville	Alabama
United States	Alabama Infectious Diseases Center	Huntsville	Alabama
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Guthrie Medical Group	Ithaca	New York
United States	Duval County Health Department	Jacksonville	Florida
United States	Nemechek Health Renewal	Kansas City	Missouri
United States	Kaiser Permanete of Colorado Rock Creek Medical Offices	Lafayette	Colorado
United States	Ingham County Health Department	Lansing	Michigan
United States	Michigan State University College of Osteopathic Medicine	Lansing	Michigan
United States	Blue Grass Care Clinic	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Bickerstaff Pediatric Family HIV Center	Long Beach	California
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Cedars Sinai Medical Group	Los Angeles	California
United States	LA Gay and Lesbian Center	Los Angeles	California
United States	Office of Peter J. Ruane, MD	Los Angeles	California
United States	Infectious Diseases Associates of Central Virginia	Lynchburg	Virginia
United States	North Shore University Hospital	Manhasset	New York
United States	WellStar Clinical Trials Office	Marietta	Georgia
United States	WellStar Infectious Disease	Marietta	Georgia
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Care Resource	Miami	Florida
United States	South Florida Infectious Deisease and Tropical Medicine Center	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Office of Albert Canas, MD	Miami Beach	Florida
United States	Jersey Shore Medical Center	Neptune	New Jersey
United States	Meridian Medical Associates	Neptune	New Jersey
United States	Clinical AIDS & HIV	New Haven	Connecticut
United States	Hospital of Saint Raphael	New Haven	Connecticut
United States	Yale University School of Medicine Aids Program	New Haven	Connecticut
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Beth Israel Medical Clinic	New York	New York
United States	Columbia University Medical Center	New York	New York
United States	CUMC Research Pharmacy	New York	New York
United States	HIV & Internal Medicine	New York	New York
United States	Mount Sinai Beth Israel Medical Center	New York	New York
United States	Mount Sinai Downtown Comprehensive Health Program	New York	New York
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Circle Medical, LLC	Norwalk	Connecticut
United States	Alta Bates Summit Medical Center East Bay AIDS Center	Oakland	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Office of William Johnson, M.D.	Olympia Fields	Illinois
United States	Southside Health Association	Olympia Fields	Illinois
United States	University of California Irvine Medical Center	Orange	California
United States	A Professional Corporation, Research Department	Palm Desert	California
United States	Stanford ACTG	Palo Alto	California
United States	Philadelphia Fight	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Dr. Howard Kussman, MD	Plano	Texas
United States	Kaiser Permanente Northwest Region, Immune Deficiency Clinic	Portland	Oregon
United States	The Research and Education Group	Portland	Oregon
United States	Infectious Diseases Associates	Riverdale	Georgia
United States	AIDS Care	Rochester	New York
United States	Federal Medical Center Rochester	Rochester	Minnesota
United States	Mayo Medical Clinic	Rochester	Minnesota
United States	University of California	Sacramento	California
United States	Health Positive	Safety Harbor	Florida
United States	Central West Clinical Research	Saint Louis	Missouri
United States	Pinellas Care Clinic	Saint Petersburg	Florida
United States	South Texas Veterans Health Care System	San Antonio	Texas
United States	University Health Care System	San Antonio	Texas
United States	Kaiser Permanente Medical Center	San Francisco	California
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California
United States	Chatham County Health Department	Savannah	Georgia
United States	Guthrie Clinic, Ltd.	Sayre	Pennsylvania
United States	Group Health Cooperative	Seattle	Washington
United States	Montgomery Infectious Disease Associates, P.A. (Private Practice)	Silver Spring	Maryland
United States	Newland Medical Associates	Southfield	Michigan
United States	Baystate Infectious Diseases Clinical Research	Springfield	Massachusetts
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	The Research Institute	Springfield	Massachusetts
United States	Statnford University Medical Center	Stanford	California
United States	Infectious Disease Research Institute, Inc	Tampa	Florida
United States	Midtown Medical Center	Tampa	Florida
United States	St. Joseph's Hospital Comprehensive Research Institute	Tampa	Florida
United States	Tampa Care Clinic	Tampa	Florida
United States	University of Toledo: Health Sciences Campus	Toledo	Ohio
United States	New York Medical College	Valhalla	New York
United States	Westchester Medical Center	Valhalla	New York
United States	Bipin Bhagat MD Inc.	Victorville	California
United States	Division of Infectious Diseases, George Washington University Medical Center	Washington	District of Columbia
United States	Dupont Circle Physician's Group	Washington	District of Columbia
United States	Family Medical Counseling Service	Washington	District of Columbia
United States	George Washington University Medical Faculty Assoc	Washington	District of Columbia
United States	Office of Mahmoud H. Mustafa, MD, FACP	Washington	District of Columbia
United States	Rowan Tree Medical, PA	Wilton Manors	Florida
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  France,  Germany,  Greece,  Italy,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	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.	Up to 5 years following enrollment
Primary	Percentage of Participants With All-Cause Mortality	All-cause death was defined as the death due to any cause during the course of study.	Up to 5 years following enrollment