The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00426660




Registration number
NCT00426660
Ethics application status
Date submitted
22/01/2007
Date registered
25/01/2007
Date last updated
29/06/2016

Titles & IDs
Public title
Expanded Access Program for Maraviroc At Multiple Centers
Scientific title
A Multicenter, Open Label, Expanded Access Trial Of Maraviroc
Secondary ID [1] 0 0
2006-004306-50
Secondary ID [2] 0 0
A4001050
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - maraviroc

Experimental: 1 -


Treatment: Drugs: maraviroc
The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline up to Week 144
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline up to Week 144
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline up to Week 144
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline up to Week 144
Primary outcome [5] 0 0
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load
Timepoint [5] 0 0
Baseline up to Week 144
Primary outcome [6] 0 0
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
Timepoint [6] 0 0
Baseline up to Week 144
Primary outcome [7] 0 0
Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
Timepoint [7] 0 0
Baseline up to Week 144
Primary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline up to Week 144
Primary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline up to Week 144
Primary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline up to Week 144
Primary outcome [11] 0 0
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.
Timepoint [11] 0 0
Baseline up to Week 144
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline up to Week 144
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline up to Week 144
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline up to Week 144
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline up to Week 144
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline up to Week 144
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline up to Week 144
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline up to Week 144
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline up to Week 144
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Day 1 up to Week 144
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline up to Week 144
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Screening up to Week 144
Secondary outcome [12] 0 0
Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau - Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on--treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.
Timepoint [12] 0 0
Baseline up to Week 144
Secondary outcome [13] 0 0
Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120) - Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre--treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV--1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.
Timepoint [13] 0 0
Baseline up to Week 144

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having
previously prematurely discontinued Maraviroc in trials

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Albion Street Centre - Surry Hills
Recruitment hospital [4] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [5] 0 0
AIDS Medical Centre - Brisbane
Recruitment hospital [6] 0 0
Infectious Diseases Unit - Herston
Recruitment hospital [7] 0 0
Infectious Diseases Unit - Adelaide
Recruitment hospital [8] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [9] 0 0
Clinical Research Unit, Infectious Diseases - Melbourne
Recruitment hospital [10] 0 0
Northside Clinic - North Fitzroy
Recruitment hospital [11] 0 0
Prahran Market Clinic - South Yarra
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Surry Hills
Recruitment postcode(s) [3] 0 0
2145 - Wentworthville
Recruitment postcode(s) [4] 0 0
4000 - Brisbane
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3068 - North Fitzroy
Recruitment postcode(s) [10] 0 0
3141 - South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Montana
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Austria
State/province [33] 0 0
A-1090
Country [34] 0 0
Austria
State/province [34] 0 0
Graz
Country [35] 0 0
Austria
State/province [35] 0 0
Wien
Country [36] 0 0
Belgium
State/province [36] 0 0
Antwerpen
Country [37] 0 0
Belgium
State/province [37] 0 0
Bruxelles
Country [38] 0 0
Belgium
State/province [38] 0 0
Charleroi
Country [39] 0 0
Belgium
State/province [39] 0 0
Gent
Country [40] 0 0
Belgium
State/province [40] 0 0
Jette
Country [41] 0 0
Belgium
State/province [41] 0 0
Leuven
Country [42] 0 0
Belgium
State/province [42] 0 0
Liège
Country [43] 0 0
Canada
State/province [43] 0 0
Nova Scotia
Country [44] 0 0
Canada
State/province [44] 0 0
Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
Chile
State/province [46] 0 0
RM
Country [47] 0 0
Costa Rica
State/province [47] 0 0
San Jose
Country [48] 0 0
Dominican Republic
State/province [48] 0 0
Santo Domingo
Country [49] 0 0
France
State/province [49] 0 0
Cedex 09
Country [50] 0 0
France
State/province [50] 0 0
Cedex 12
Country [51] 0 0
France
State/province [51] 0 0
Cedex
Country [52] 0 0
France
State/province [52] 0 0
Besancon
Country [53] 0 0
France
State/province [53] 0 0
Bobigny Cedex
Country [54] 0 0
France
State/province [54] 0 0
Bordeaux Cedex
Country [55] 0 0
France
State/province [55] 0 0
Bordeaux
Country [56] 0 0
France
State/province [56] 0 0
Clermont Ferrand
Country [57] 0 0
France
State/province [57] 0 0
Grenoble Cedex 09
Country [58] 0 0
France
State/province [58] 0 0
La Source
Country [59] 0 0
France
State/province [59] 0 0
Le Kremlin Bicêtre
Country [60] 0 0
France
State/province [60] 0 0
Lyon Cedex 02
Country [61] 0 0
France
State/province [61] 0 0
Lyon Cedex 04
Country [62] 0 0
France
State/province [62] 0 0
Montpellier
Country [63] 0 0
France
State/province [63] 0 0
Nantes
Country [64] 0 0
France
State/province [64] 0 0
Nice Cedex 3, 06
Country [65] 0 0
France
State/province [65] 0 0
Paris Cedex 10
Country [66] 0 0
France
State/province [66] 0 0
Paris CEDEX 14
Country [67] 0 0
France
State/province [67] 0 0
Paris cedex 15
Country [68] 0 0
France
State/province [68] 0 0
Paris
Country [69] 0 0
France
State/province [69] 0 0
Rennes
Country [70] 0 0
France
State/province [70] 0 0
Toulouse
Country [71] 0 0
France
State/province [71] 0 0
Tourcoing
Country [72] 0 0
France
State/province [72] 0 0
Villejuif
Country [73] 0 0
Germany
State/province [73] 0 0
Berlin
Country [74] 0 0
Germany
State/province [74] 0 0
Dresden
Country [75] 0 0
Germany
State/province [75] 0 0
Essen
Country [76] 0 0
Germany
State/province [76] 0 0
Freiburg
Country [77] 0 0
Germany
State/province [77] 0 0
Hannover
Country [78] 0 0
Germany
State/province [78] 0 0
Koeln
Country [79] 0 0
Greece
State/province [79] 0 0
Attiki
Country [80] 0 0
Greece
State/province [80] 0 0
Athens
Country [81] 0 0
Greece
State/province [81] 0 0
Patras
Country [82] 0 0
Greece
State/province [82] 0 0
Piraeus
Country [83] 0 0
Greece
State/province [83] 0 0
Thessaloniki
Country [84] 0 0
Hong Kong
State/province [84] 0 0
Kowloon
Country [85] 0 0
India
State/province [85] 0 0
Karnataka
Country [86] 0 0
India
State/province [86] 0 0
Maharashtra
Country [87] 0 0
India
State/province [87] 0 0
Tamil Nadu
Country [88] 0 0
Ireland
State/province [88] 0 0
Dublin
Country [89] 0 0
Italy
State/province [89] 0 0
Bari
Country [90] 0 0
Italy
State/province [90] 0 0
Bologna
Country [91] 0 0
Italy
State/province [91] 0 0
Brescia
Country [92] 0 0
Italy
State/province [92] 0 0
Catania
Country [93] 0 0
Italy
State/province [93] 0 0
Chieti Scalo
Country [94] 0 0
Italy
State/province [94] 0 0
Ferrara
Country [95] 0 0
Italy
State/province [95] 0 0
Firenze
Country [96] 0 0
Italy
State/province [96] 0 0
Genova
Country [97] 0 0
Italy
State/province [97] 0 0
Milano
Country [98] 0 0
Italy
State/province [98] 0 0
Modena
Country [99] 0 0
Italy
State/province [99] 0 0
Padova
Country [100] 0 0
Italy
State/province [100] 0 0
Pavia
Country [101] 0 0
Italy
State/province [101] 0 0
Pescara
Country [102] 0 0
Italy
State/province [102] 0 0
Roma
Country [103] 0 0
Italy
State/province [103] 0 0
Torino
Country [104] 0 0
Italy
State/province [104] 0 0
Torrette di Ancona
Country [105] 0 0
Italy
State/province [105] 0 0
Venezia
Country [106] 0 0
Malaysia
State/province [106] 0 0
Kelantan
Country [107] 0 0
Malaysia
State/province [107] 0 0
Selangor
Country [108] 0 0
Mexico
State/province [108] 0 0
DF
Country [109] 0 0
Mexico
State/province [109] 0 0
Jalisco
Country [110] 0 0
Mexico
State/province [110] 0 0
Mexico Df
Country [111] 0 0
Netherlands
State/province [111] 0 0
Utrecht
Country [112] 0 0
Portugal
State/province [112] 0 0
Cascais
Country [113] 0 0
Portugal
State/province [113] 0 0
Lisboa
Country [114] 0 0
Portugal
State/province [114] 0 0
Lisbon
Country [115] 0 0
Portugal
State/province [115] 0 0
Porto
Country [116] 0 0
Puerto Rico
State/province [116] 0 0
Ponce
Country [117] 0 0
Puerto Rico
State/province [117] 0 0
San Juan
Country [118] 0 0
Romania
State/province [118] 0 0
Sector 2
Country [119] 0 0
Romania
State/province [119] 0 0
Bucharest
Country [120] 0 0
Romania
State/province [120] 0 0
Constanta
Country [121] 0 0
Romania
State/province [121] 0 0
Iasi
Country [122] 0 0
Spain
State/province [122] 0 0
Alicante
Country [123] 0 0
Spain
State/province [123] 0 0
Barcelona
Country [124] 0 0
Spain
State/province [124] 0 0
Bilbao
Country [125] 0 0
Spain
State/province [125] 0 0
Cantabria
Country [126] 0 0
Spain
State/province [126] 0 0
Gijon
Country [127] 0 0
Spain
State/province [127] 0 0
La Coruña
Country [128] 0 0
Spain
State/province [128] 0 0
Pontevedra
Country [129] 0 0
Spain
State/province [129] 0 0
San Sebastian
Country [130] 0 0
Spain
State/province [130] 0 0
Santa Cruz de Tenerife
Country [131] 0 0
Spain
State/province [131] 0 0
Tarragona
Country [132] 0 0
Spain
State/province [132] 0 0
Vizcaya
Country [133] 0 0
Spain
State/province [133] 0 0
Cadiz
Country [134] 0 0
Spain
State/province [134] 0 0
Cordoba
Country [135] 0 0
Spain
State/province [135] 0 0
Granada
Country [136] 0 0
Spain
State/province [136] 0 0
Madrid
Country [137] 0 0
Spain
State/province [137] 0 0
Malaga
Country [138] 0 0
Spain
State/province [138] 0 0
Sevilla
Country [139] 0 0
Spain
State/province [139] 0 0
Valencia
Country [140] 0 0
Switzerland
State/province [140] 0 0
Zürich
Country [141] 0 0
Taiwan
State/province [141] 0 0
Kaohsiung County
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Sussex
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Crumpsall, Manchester
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Edinburgh
Country [145] 0 0
United Kingdom
State/province [145] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ViiV Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00426660
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications