Active, not recruiting

Study Description:

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.

Viiv Study ID:

A4001067


Clinicaltrials.gov Identifier:

NCT00665561


EudraCT Number:

2007-006148-24


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

maraviroc

Collaborators

Pfizer, Inc.


Date

March 2008 to March 2008

Type

Observational

Phase

N/A


Gender

Both

Age

18 Years - N/A

Accepts Healthy Volunteers

No


Study Documents

No documents available
This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    Not available

  • Central Contact Phone:

    1-800-718-1021

  • Central Contact Email:

    [email protected]

Belgium, Antwerpen B-2000No longer recruiting
Belgium, Brussels 1000No longer recruiting
Belgium, Brussels 1200No longer recruiting
Belgium, Leuven B-3000No longer recruiting
Belgium, Liege 4000No longer recruiting
Brazil, DF, Brasilia 70351-580No longer recruiting
Brazil, PARANA, Curitiba 80240-280No longer recruiting
Brazil, RJ, Nova Iguacu 26030-380No longer recruiting
Brazil, SP, Santo André 09060-650No longer recruiting
Brazil, SP, Sao Paulo 04121-000No longer recruiting
Brazil, SP, São Paulo 04231-030No longer recruiting
Canada, BC, Vancouver V6Z 2C7No longer recruiting
Canada, NS, Halifax B3H 1V7No longer recruiting
Canada, ON, Toronto M4N 3M5No longer recruiting
Canada, ON, Toronto M5G 2N2No longer recruiting
Canada, QC, Montreal H2W 1T8No longer recruiting
Canada, QC, Montreal H2L 5B1Terminated
Canada, QC, Quebec G1V 4X7Terminated
France, Bondy 93140No longer recruiting
France, Bordeaux 33076No longer recruiting
France, Bordeaux 33075No longer recruiting
France, Garches 92380No longer recruiting
France, LYON 69288No longer recruiting
France, Marseille Cedex 09 13274No longer recruiting
France, PESSAC Cedex 33604No longer recruiting
France, Paris 75908No longer recruiting
France, Paris 75651No longer recruiting
France, Paris 75020No longer recruiting
France, Paris 75010No longer recruiting
France, Perpignan 66000Terminated
France, FRANCE, Paris Cedex 14 75014No longer recruiting
France, FRANCE, Rennes 35033 Cedex 09No longer recruiting
France, FRANCE, Tourcoing 59208No longer recruiting
Germany, Aachen 52062No longer recruiting
Germany, Berlin 10243No longer recruiting
Germany, Berlin D-10243No longer recruiting
Germany, Dortmund 44137No longer recruiting
Germany, Dresden D-01307No longer recruiting
Germany, Frankfurt am Main D-60590No longer recruiting
Germany, Fuerth 90762Terminated
Germany, Hamburg 20146No longer recruiting
Germany, Hamburg D-20246No longer recruiting
Germany, Hamburg D-20099No longer recruiting
Germany, Koeln D-50937No longer recruiting
Germany, Mainz D-55131Terminated
Germany, Mannheim D-68161No longer recruiting
Germany, Muenchen 81371No longer recruiting
Germany, Muenchen D-80336No longer recruiting
Germany, Muenchen D 80335No longer recruiting
Germany, Muenster 48143Terminated
Germany, Osnabruck D-49090No longer recruiting
Germany, Stuttgart D-70197No longer recruiting
Germany, Stuttgart D-70197No longer recruiting
Greece, Athens 161 21No longer recruiting
Greece, Piraues 185 36No longer recruiting
Greece, ACHAIA, Patras 26 500No longer recruiting
Italy, Bari 70124No longer recruiting
Italy, Bologna 40133No longer recruiting
Italy, Bologna 40138No longer recruiting
Italy, Busto Arsizio-Varese 21052No longer recruiting
Italy, Firenze 50139No longer recruiting
Italy, Genova 16128No longer recruiting
Italy, Milan 20142No longer recruiting
Italy, Milan 20127No longer recruiting
Italy, Milano 20157No longer recruiting
Italy, Milano 20157No longer recruiting
Italy, Modena 41100No longer recruiting
Italy, Naples 80135No longer recruiting
Italy, Napoli 80137Terminated
Italy, Palermo 90127No longer recruiting
Italy, Pavia 27100No longer recruiting
Italy, Pescara 65100No longer recruiting
Italy, Roma 00149No longer recruiting
Italy, Roma 00149No longer recruiting
Italy, Roma 00161No longer recruiting
Italy, Roma 00168No longer recruiting
Italy, Rome 00184No longer recruiting
Italy, Torino 10100No longer recruiting
Italy, Torino 10149No longer recruiting
Puerto Rico, PR, Ponce 00717-1567No longer recruiting
Puerto Rico, Puerto Rico, San Juan 00909No longer recruiting
Spain, Barcelona 08916No longer recruiting
Spain, CADIZ 11009No longer recruiting
Spain, Elche 03203No longer recruiting
Spain, Granada 18012No longer recruiting
Spain, MADRID 28040No longer recruiting
Spain, Madrid 28046No longer recruiting
Spain, Madrid 28041No longer recruiting
Spain, Madrid 28006No longer recruiting
Spain, Mataro 08304No longer recruiting
Spain, Mostoles, Madrid 28935No longer recruiting
Spain, SAN SEBASTIAN 20014No longer recruiting
Spain, SEVILLA 41009No longer recruiting
Spain, TENERIFE 38320No longer recruiting
Spain, A CORUÑA, A CORUÑA 15006No longer recruiting
Spain, BARCELONA, BARCELONA 08036No longer recruiting
Spain, BARCELONA, BARCELONA 08003No longer recruiting
Spain, BARCELONA, TERRASSA 08221Terminated
Spain, CORDOBA, CORDOBA 14004No longer recruiting
Spain, LA RIOJA, LOGROÑO 26006No longer recruiting
Spain, MALAGA, MALAGA 29010No longer recruiting
Spain, Madrid, MADRID 28029No longer recruiting
Spain, Madrid, MADRID 28034No longer recruiting
Spain, SEVILLA, SEVILLA 41013No longer recruiting
Spain, SPAIN, Alicante 03010No longer recruiting
Spain, TARRAGONA, TORTOSA 43500Terminated
Spain, VALENCIA, VALENCIA 46010No longer recruiting
United Kingdom, Belfast BT12 6BANo longer recruiting
United Kingdom, Birmingham B4 6DHNo longer recruiting
United Kingdom, Brighton BN2 1ESNo longer recruiting
United Kingdom, Crumpsall, Manchester M8 5RBNo longer recruiting
United Kingdom, Darlington DL36HXTerminated
United Kingdom, Edinburgh EH4 2XUNo longer recruiting
United Kingdom, London SW10 9NHNo longer recruiting
United Kingdom, London E1 1BBNo longer recruiting
United Kingdom, London N18 1QXNo longer recruiting
United Kingdom, London NW3 2QGNo longer recruiting
United Kingdom, Newcastle Upon Tyne NE1 4LPNo longer recruiting
United Kingdom, Newcastle upon Tyne NE1 4LPNo longer recruiting
United Kingdom, Shoreham-by-sea, West Sussex BN43 6TQNo longer recruiting
United Kingdom, Stoke on Trent, Staffordshire ST6 2JWNo longer recruiting
United Kingdom, Tooting SW17 0QTNo longer recruiting
United Kingdom, EAST YORKSHIRE, Cottingham HU16 5JQNo longer recruiting
United Kingdom, NEWCASTLE, Newcastle upon Tyne NE4 6BENo longer recruiting
United States, AL, Hobson City 36201No longer recruiting
United States, AL, Huntsville 35801Terminated
United States, AL, Huntsville 35801Terminated
United States, CA, Bakersfield 93301No longer recruiting
United States, CA, Burbank 91505Terminated
United States, CA, Fountain Valley 92708No longer recruiting
United States, CA, Long Beach 90806No longer recruiting
United States, CA, Los Angeles 90028No longer recruiting
United States, CA, Los Angeles 90036No longer recruiting
United States, CA, Los Angeles 90048No longer recruiting
United States, CA, Oakland 95035No longer recruiting
United States, CA, Orange 92868No longer recruiting
United States, CA, Palm Desert 92211No longer recruiting
United States, CA, Palo Alto 94304-5350Terminated
United States, CA, Sacramento 95817No longer recruiting
United States, CA, San Francisco 94118Terminated
United States, CA, San Francisco 94121Terminated
United States, CA, Stanford 94305Terminated
United States, CA, Victorville 92395Terminated
United States, CO, Denver 80205No longer recruiting
United States, CO, Denver 80206No longer recruiting
United States, CO, Lafayette 80026No longer recruiting
United States, CT, New Haven 06511Terminated
United States, CT, New Haven 06511Terminated
United States, CT, New Haven 06510No longer recruiting
United States, CT, Norwalk 06851No longer recruiting
United States, DC, Washington 20037No longer recruiting
United States, DC, Washington 20009No longer recruiting
United States, DC, Washington 20020Terminated
United States, DC, Washington 20037No longer recruiting
United States, DC, Washington 20037Terminated
United States, FL, Boynton Beach 33426Terminated
United States, FL, Daytona Beach 32114No longer recruiting
United States, FL, Fort Myers 33901No longer recruiting
United States, FL, Fort Pierce 34982No longer recruiting
United States, FL, Jacksonville 32206No longer recruiting
United States, FL, Miami 33137No longer recruiting
United States, FL, Miami 33176No longer recruiting
United States, FL, Miami 33136No longer recruiting
United States, FL, Miami Beach 33139No longer recruiting
United States, FL, Safety Harbor 34695Terminated
United States, FL, St. Petersburg 33713No longer recruiting
United States, FL, Tampa 33614No longer recruiting
United States, FL, Tampa 33614No longer recruiting
United States, FL, Tampa 33614No longer recruiting
United States, FL, Tampa 33614No longer recruiting
United States, FL, Wilton Manors 33305No longer recruiting
United States, GA, Atlanta 30329Terminated
United States, GA, Atlanta 30309No longer recruiting
United States, GA, Atlanta 30342No longer recruiting
United States, GA, Atlanta 30318No longer recruiting
United States, GA, Atlanta 30339-3915No longer recruiting
United States, GA, Augusta 30912Terminated
United States, GA, Decatur 30033No longer recruiting
United States, GA, Marietta 30060No longer recruiting
United States, GA, Marietta 30060No longer recruiting
United States, GA, Riverdale 30274No longer recruiting
United States, GA, Savannah 31401No longer recruiting
United States, GA, marietta 30060No longer recruiting
United States, IA, Iowa City 52242Terminated
United States, IL, Chicago 60613No longer recruiting
United States, IL, Chicago 60612No longer recruiting
United States, IL, Chicago 60637No longer recruiting
United States, IL, Olympia Fields 60461Terminated
United States, IL, Olympia fields 60461Terminated
United States, IL, Springfield 62702No longer recruiting
United States, KY, Lexington 40536No longer recruiting
United States, KY, Lexington 40536No longer recruiting
United States, KY, Lexington 40536No longer recruiting
United States, LA, New Orleans 70112No longer recruiting
United States, LA, New Orleans 70119No longer recruiting
United States, MA, Brighton 02135Terminated
United States, MA, Springfield 01199No longer recruiting
United States, MA, Springfield 01107No longer recruiting
United States, MD, Silver Spring 20910No longer recruiting
United States, MI, Ann Arbor 48109No longer recruiting
United States, MI, Detroit 48202No longer recruiting
United States, MI, Grosse Pointe Woods 48236No longer recruiting
United States, MI, Lansing 48910No longer recruiting
United States, MI, Lansing 48910No longer recruiting
United States, MI, Southfield 48075No longer recruiting
United States, MN, Rochester 55904No longer recruiting
United States, MN, Rochester 55905No longer recruiting
United States, MO, Kansas City 64111-2610Terminated
United States, MO, Saint Louis 63108No longer recruiting
United States, NC, Gastonia 28054Terminated
United States, NC, Greenville 27834No longer recruiting
United States, NC, Huntersville 28078Terminated
United States, NC, Winston Salem 27157No longer recruiting
United States, NJ, Long Branch 07740No longer recruiting
United States, NJ, Neptune 07754No longer recruiting
United States, NJ, Neptune 07754No longer recruiting
United States, NJ, Newark 07102Terminated
United States, NY, Buffalo 14215No longer recruiting
United States, NY, Ithaca 14850No longer recruiting
United States, NY, Manhasset 11030No longer recruiting
United States, NY, New York 10003No longer recruiting
United States, NY, New York 10003No longer recruiting
United States, NY, New York 10032No longer recruiting
United States, NY, New York 10032No longer recruiting
United States, NY, New York 10011Terminated
United States, NY, New York 10003No longer recruiting
United States, NY, New York 10011No longer recruiting
United States, NY, Rochester 14607No longer recruiting
United States, NY, Valhalla 10595No longer recruiting
United States, NY, Valhalla 10595No longer recruiting
United States, OH, Cincinnati 45267No longer recruiting
United States, OH, Columbus 43210No longer recruiting
United States, OH, Toledo 43614No longer recruiting
United States, OK, Oklahoma City 73104No longer recruiting
United States, OR, Portland 97227No longer recruiting
United States, OR, Portland 97210Terminated
United States, PA, Allentown 18102No longer recruiting
United States, PA, Harrisburg 17110Terminated
United States, PA, Philadelphia 19107No longer recruiting
United States, PA, Philadelphia 19104No longer recruiting
United States, PA, Philadelphia 19104-6073No longer recruiting
United States, PA, Sayre 18840No longer recruiting
United States, SC, Charleston 29414Terminated
United States, SC, Charleston 29425No longer recruiting
United States, SC, Columbia 29203No longer recruiting
United States, SC, Columbia 29203No longer recruiting
United States, SC, Columbia 29203No longer recruiting
United States, TX, Austin 78705Terminated
United States, TX, Bellaire 77401No longer recruiting
United States, TX, Dallas 75216No longer recruiting
United States, TX, Dallas 75243Terminated
United States, TX, Dallas 75219No longer recruiting
United States, TX, Dallas 75235No longer recruiting
United States, TX, Fort Worth 76104No longer recruiting
United States, TX, Fort Worth 76104No longer recruiting
United States, TX, Fort Worth 76104No longer recruiting
United States, TX, Harlingen 78550No longer recruiting
United States, TX, Harlingen 78550Terminated
United States, TX, Houston 77057No longer recruiting
United States, TX, Houston 77030No longer recruiting
United States, TX, Plano 75075Terminated
United States, TX, San Antonio 78229No longer recruiting
United States, TX, San Antonio 78207No longer recruiting
United States, VA, Danville 24541No longer recruiting
United States, VA, Lynchburg 24501No longer recruiting
United States, WA, Seattle 98112No longer recruiting
United States, WV, Huntington 25701No longer recruiting

Study Design

  • Primary Purpose: Not Available
  • Allocation: Not Available
  • Study Design: Not Available
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Not Available
  • Masked Caregiver: Not Available
  • Masked Investigator: Not Available
  • Masked Assessor: Not Available
Primary Outcomes:

  • CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths
    Timeframe: Followed till 6 months after drug discontinuation up to a total of 5 years.

  • All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality
    Timeframe: Followed for a total of up to 5 years regardless of the time of drug discontinuaion.

Secondary Outcomes:

  • There are no Secondary Outcomes for this study.
    Timeframe: 0

Arms:
  • N/A

Interventions:

  • Drug: Maraviroc along with an optimized background antiretroviral drug regimen
  • Drug: Optimized background antiretroviral drug regimen without maraviroc

Keyword:

  • Maraviroc, HIV-1, Safety, Non-interventional
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 2454