Advanced HIV Infection Clinical Trial
Official title:
A Multi-Center, Open Label, Expanded Access Trial Of Maraviroc
| Verified date | September 2011 |
| Source | ViiV Healthcare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.
| Status | Completed |
| Enrollment | 1047 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening - Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay - Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law. Exclusion Criteria: - Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Australia | Pfizer Investigational Site | Adelaide | South Australia |
| Australia | Pfizer Investigational Site | Brisbane | Queensland |
| Australia | Pfizer Investigational Site | Carlton | Victoria |
| Australia | Pfizer Investigational Site | Darlinghurst | New South Wales |
| Australia | Pfizer Investigational Site | Herston | Queensland |
| Australia | Pfizer Investigational Site | Melbourne | Victoria |
| Australia | Pfizer Investigational Site | North Fitzroy | Victoria |
| Australia | Pfizer Investigational Site | South Yarra | Victoria |
| Australia | Pfizer Investigational Site | Surry Hills | New South Wales |
| Australia | Pfizer Investigational Site | Wentworthville | New South Wales |
| Austria | Pfizer Investigational Site | A-1090 | |
| Austria | Pfizer Investigational Site | Graz | |
| Austria | Pfizer Investigational Site | Wien | |
| Belgium | Pfizer Investigational Site | Antwerpen | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Charleroi | |
| Belgium | Pfizer Investigational Site | Gent | |
| Belgium | Pfizer Investigational Site | Jette | |
| Belgium | Pfizer Investigational Site | Leuven | |
| Belgium | Pfizer Investigational Site | Liège | |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | Hamilton | Ontario |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Chile | Pfizer Investigational Site | Santiago | RM |
| Chile | Pfizer Investigational Site | Santiago | RM |
| Costa Rica | Pfizer Investigational Site | Barrio Aranjuez | San Jose |
| Dominican Republic | Pfizer Investigational Site | Santo Domingo | |
| France | Pfizer Investigational Site | Besancon | |
| France | Pfizer Investigational Site | Bobigny Cedex | |
| France | Pfizer Investigational Site | Bordeaux | |
| France | Pfizer Investigational Site | Bordeaux Cedex | |
| France | Pfizer Investigational Site | Caen | Cedex |
| France | Pfizer Investigational Site | Clermont Ferrand | |
| France | Pfizer Investigational Site | Grenoble Cedex 09 | |
| France | Pfizer Investigational Site | La Source | |
| France | Pfizer Investigational Site | Le Kremlin Bicêtre | |
| France | Pfizer Investigational Site | Lyon Cedex 02 | |
| France | Pfizer Investigational Site | Lyon Cedex 04 | |
| France | Pfizer Investigational Site | Marseille | Cedex 09 |
| France | Pfizer Investigational Site | Montpellier | |
| France | Pfizer Investigational Site | Nantes | |
| France | Pfizer Investigational Site | Nice Cedex 3, 06 | |
| France | Pfizer Investigational Site | Paris | Cedex 12 |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris Cedex 10 | |
| France | Pfizer Investigational Site | Paris CEDEX 14 | |
| France | Pfizer Investigational Site | Paris cedex 15 | |
| France | Pfizer Investigational Site | Rennes | |
| France | Pfizer Investigational Site | Toulouse | |
| France | Pfizer Investigational Site | Tourcoing | |
| France | Pfizer Investigational Site | Villejuif | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Dresden | |
| Germany | Pfizer Investigational Site | Essen | |
| Germany | Pfizer Investigational Site | Freiburg | |
| Germany | Pfizer Investigational Site | Hannover | |
| Germany | Pfizer Investigational Site | Koeln | |
| Greece | Pfizer Investigational Site | Athens | Attiki |
| Greece | Pfizer Investigational Site | Athens | Attiki |
| Greece | Pfizer Investigational Site | Athens | |
| Greece | Pfizer Investigational Site | Athens | |
| Greece | Pfizer Investigational Site | Patras | |
| Greece | Pfizer Investigational Site | Piraeus | |
| Greece | Pfizer Investigational Site | Thessaloniki | |
| Hong Kong | Pfizer Investigational Site | Kowloon | |
| India | Pfizer Investigational Site | Bangalore | Karnataka |
| India | Pfizer Investigational Site | Chennai | Tamil Nadu |
| India | Pfizer Investigational Site | Mumbai | Maharashtra |
| Ireland | Pfizer Investigational Site | Dublin | |
| Ireland | Pfizer Investigational Site | Dublin | |
| Italy | Pfizer Investigational Site | Bari | |
| Italy | Pfizer Investigational Site | Bologna | |
| Italy | Pfizer Investigational Site | Brescia | |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Chieti Scalo | |
| Italy | Pfizer Investigational Site | Ferrara | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Genova | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Modena | |
| Italy | Pfizer Investigational Site | Padova | |
| Italy | Pfizer Investigational Site | Pavia | |
| Italy | Pfizer Investigational Site | Pescara | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Torino | |
| Italy | Pfizer Investigational Site | Torrette di Ancona | |
| Italy | Pfizer Investigational Site | Venezia | |
| Malaysia | Pfizer Investigational Site | Kota Bharu | Kelantan |
| Malaysia | Pfizer Investigational Site | Sungai Buloh | Selangor |
| Mexico | Pfizer Investigational Site | Guadalajara | Jalisco |
| Mexico | Pfizer Investigational Site | Mexico | DF |
| Mexico | Pfizer Investigational Site | Tlalpan | Mexico Df |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Portugal | Pfizer Investigational Site | Cascais | |
| Portugal | Pfizer Investigational Site | Lisboa | |
| Portugal | Pfizer Investigational Site | Lisboa | |
| Portugal | Pfizer Investigational Site | Porto | |
| Puerto Rico | Pfizer Investigational Site | Ponce | |
| Puerto Rico | Pfizer Investigational Site | Santurce | |
| Romania | Pfizer Investigational Site | Bucharest | |
| Romania | Pfizer Investigational Site | Bucuresti | Sector 2 |
| Romania | Pfizer Investigational Site | Constanta | |
| Romania | Pfizer Investigational Site | Iasi | |
| Spain | Pfizer Investigational Site | Alicante | |
| Spain | Pfizer Investigational Site | Badalona | Barcelona |
| Spain | Pfizer Investigational Site | Barakaldo | Vizcaya |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Basurto | Bilbao |
| Spain | Pfizer Investigational Site | Cabueñes | Gijon |
| Spain | Pfizer Investigational Site | Cadiz | |
| Spain | Pfizer Investigational Site | Cordoba | |
| Spain | Pfizer Investigational Site | Donostia | San Sebastian |
| Spain | Pfizer Investigational Site | Elche | Alicante |
| Spain | Pfizer Investigational Site | Granada | |
| Spain | Pfizer Investigational Site | Granada | |
| Spain | Pfizer Investigational Site | Granollers | Barcelona |
| Spain | Pfizer Investigational Site | Hospitalet de Llobregat | Barcelona |
| Spain | Pfizer Investigational Site | La Laguna | Santa Cruz de Tenerife |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Malaga | |
| Spain | Pfizer Investigational Site | Malaga | |
| Spain | Pfizer Investigational Site | Santander | Cantabria |
| Spain | Pfizer Investigational Site | Santiago de Compostela | La Coruña |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Tortosa | Tarragona |
| Spain | Pfizer Investigational Site | Valencia | |
| Spain | Pfizer Investigational Site | Valencia | |
| Spain | Pfizer Investigational Site | Valencia | |
| Spain | Pfizer Investigational Site | Valencia | |
| Spain | Pfizer Investigational Site | Vigo | Pontevedra |
| Switzerland | Pfizer Investigational Site | Zürich | |
| Taiwan | Pfizer Investigational Site | Kaohsiung County | |
| United Kingdom | Pfizer Investigational Site | Brighton | Sussex |
| United Kingdom | Pfizer Investigational Site | Crumpsall, Manchester | |
| United Kingdom | Pfizer Investigational Site | Edinburgh | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Allentown | Pennsylvania |
| United States | Pfizer Investigational Site | Annandale | Virginia |
| United States | Pfizer Investigational Site | Arlington | Virginia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Berkley | Michigan |
| United States | Pfizer Investigational Site | Beverly Hills | California |
| United States | Pfizer Investigational Site | Beverly Hills | California |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Bonita Springs | Florida |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boynton Beach | Florida |
| United States | Pfizer Investigational Site | Bronx | New York |
| United States | Pfizer Investigational Site | Bronx | New York |
| United States | Pfizer Investigational Site | Brooklyn | New York |
| United States | Pfizer Investigational Site | Brooklyn | New York |
| United States | Pfizer Investigational Site | Buffalo | New York |
| United States | Pfizer Investigational Site | Cape Coral | Florida |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Charleston | West Virginia |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Danville | Virginia |
| United States | Pfizer Investigational Site | Dayton | Ohio |
| United States | Pfizer Investigational Site | Daytona Beach | Florida |
| United States | Pfizer Investigational Site | Decatur | Georgia |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Edmonds | Washington |
| United States | Pfizer Investigational Site | El Paso | Texas |
| United States | Pfizer Investigational Site | Englewood | New Jersey |
| United States | Pfizer Investigational Site | Fairfax | Virginia |
| United States | Pfizer Investigational Site | Flushing | New York |
| United States | Pfizer Investigational Site | Fort Lauderdale | Florida |
| United States | Pfizer Investigational Site | Fort Lauderdale | Florida |
| United States | Pfizer Investigational Site | Fort Myers | Florida |
| United States | Pfizer Investigational Site | Fort Worth | Texas |
| United States | Pfizer Investigational Site | Fort Worth | Texas |
| United States | Pfizer Investigational Site | Fountain Valley | California |
| United States | Pfizer Investigational Site | Ft. Lauderdale | Florida |
| United States | Pfizer Investigational Site | Ft. Worth | Texas |
| United States | Pfizer Investigational Site | Gastonia | North Carolina |
| United States | Pfizer Investigational Site | Glastonbury | Connecticut |
| United States | Pfizer Investigational Site | Grand Rapids | Michigan |
| United States | Pfizer Investigational Site | Great Neck | New York |
| United States | Pfizer Investigational Site | Greenbelt | Maryland |
| United States | Pfizer Investigational Site | Grosse Pointe Woods | Michigan |
| United States | Pfizer Investigational Site | Hackensack | New Jersey |
| United States | Pfizer Investigational Site | Hampton | Virginia |
| United States | Pfizer Investigational Site | Harlingen | Texas |
| United States | Pfizer Investigational Site | Hayward | California |
| United States | Pfizer Investigational Site | Hobson City | Alabama |
| United States | Pfizer Investigational Site | Hollywood | Florida |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Huntersville | North Carolina |
| United States | Pfizer Investigational Site | Huntington | West Virginia |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Keego Harbor | Michigan |
| United States | Pfizer Investigational Site | Lafayette | Colorado |
| United States | Pfizer Investigational Site | Lansing | Michigan |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Long Beach | California |
| United States | Pfizer Investigational Site | Longview | Texas |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Lynchburg | Virginia |
| United States | Pfizer Investigational Site | Manhasset | New York |
| United States | Pfizer Investigational Site | Melbourne | Florida |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami Beach | Florida |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Missoula | Montana |
| United States | Pfizer Investigational Site | Modesto | California |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Newark | New Jersey |
| United States | Pfizer Investigational Site | Newport Beach | California |
| United States | Pfizer Investigational Site | North Miami Beach | Florida |
| United States | Pfizer Investigational Site | North Miami Beach | Florida |
| United States | Pfizer Investigational Site | Norwich | Connecticut |
| United States | Pfizer Investigational Site | Oakland | California |
| United States | Pfizer Investigational Site | Orlando | Florida |
| United States | Pfizer Investigational Site | Orlando | Florida |
| United States | Pfizer Investigational Site | Palm Springs | California |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Port St Lucie | Florida |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Providence | Rhode Island |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Riverdale | Georgia |
| United States | Pfizer Investigational Site | Riverside | California |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Sacramento | California |
| United States | Pfizer Investigational Site | Safety Harbor | Florida |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | Santa Clara | California |
| United States | Pfizer Investigational Site | Sarasota | Florida |
| United States | Pfizer Investigational Site | Sarasota | Florida |
| United States | Pfizer Investigational Site | Savannah | Georgia |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Silver Spring | Maryland |
| United States | Pfizer Investigational Site | Somers Point | New Jersey |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Springfield | Massachusetts |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Petersburg | Florida |
| United States | Pfizer Investigational Site | Stanton Island | New York |
| United States | Pfizer Investigational Site | Syracuse | New York |
| United States | Pfizer Investigational Site | Tallahassee | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tarzana | California |
| United States | Pfizer Investigational Site | Toledo | Ohio |
| United States | Pfizer Investigational Site | Toms River | New Jersey |
| United States | Pfizer Investigational Site | Topeka | Kansas |
| United States | Pfizer Investigational Site | Tucker | Georgia |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Vancouver | Washington |
| United States | Pfizer Investigational Site | Victorville | California |
| United States | Pfizer Investigational Site | Voorhees | New Jersey |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | West Reading | Pennsylvania |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Wilton Manors | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| ViiV Healthcare | Pfizer |
United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Malaysia, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Spain, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) | AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE. | Baseline up to Week 144 | Yes |
| Primary | Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities | Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment. | Baseline up to Week 144 | Yes |
| Primary | Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities | Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death. | Baseline up to Week 144 | Yes |
| Primary | Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses | Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug. | Baseline up to Week 144 | Yes |
| Primary | Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load | Baseline up to Week 144 | Yes | |
| Primary | Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts | Baseline up to Week 144 | Yes | |
| Primary | Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy | Baseline up to Week 144 | Yes | |
| Primary | Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender | Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication. | Baseline up to Week 144 | Yes |
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race | Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication. | Baseline up to Week 144 | Yes |
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age | Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication. | Baseline up to Week 144 | Yes |
| Primary | Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status | Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose. | Baseline up to Week 144 | Yes |
| Secondary | Percentage of Participants With =0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA) | Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference. |
Baseline up to Week 144 | No |
| Secondary | Percentage of Participants With =1.0 log10 Reduction From Baseline in HIV 1 RNA | Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference. | Baseline up to Week 144 | No |
| Secondary | Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL | Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference. | Baseline up to Week 144 | No |
| Secondary | Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL | Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference. | Baseline up to Week 144 | No |
| Secondary | Change From Baseline in CD4 Cell Count | Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value. | Baseline up to Week 144 | No |
| Secondary | Change From Baseline in CD4 Cell Count Percent | Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value. | Baseline up to Week 144 | No |
| Secondary | Change From Baseline in CD8 Cell Count | Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value. | Baseline up to Week 144 | No |
| Secondary | Change From Baseline in CD8 Cell Count Percent | Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value. | Baseline up to Week 144 | No |
| Secondary | Median Time to Virologic Failure | Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA = 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a = 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. | Day 1 up to Week 144 | No |
| Secondary | Emergence of Resistance to Maraviroc | Resistance defined by genotypic changes in the V3 loop of HIV 1 viral envelope glycoprotein 120 [gp 120] and/or the entire gp 120 gene associated with decreased susceptibility to maraviroc for participants who meet the definition of virologic failure during the trial. | Baseline up to Week 144 | No |
| Secondary | Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure | Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ. | Baseline up to Week 144 | No |
| Secondary | Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure | Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA =0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a = 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. | Screening up to Week 144 | No |