ClinicalTrials.gov

History of Changes for Study: NCT00665561
Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)
Latest version (submitted October 12, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 23, 2008 None (earliest Version on record)
2 April 25, 2008 Study Status
3 May 8, 2008 Conditions and Study Status
4 May 23, 2008 Recruitment Status, Study Status, Conditions and Contacts/Locations
5 June 9, 2008 Study Status and Contacts/Locations
6 June 30, 2008 Study Status and Contacts/Locations
7 July 30, 2008 Study Status and Contacts/Locations
8 September 7, 2008 Contacts/Locations and Study Status
9 September 16, 2008 Contacts/Locations and Study Status
10 September 25, 2008 Study Status, Contacts/Locations and Groups and Interventions
11 October 8, 2008 Contacts/Locations, Study Status and Groups and Interventions
12 October 20, 2008 Contacts/Locations and Study Status
13 October 30, 2008 Study Status, Contacts/Locations and Groups and Interventions
14 November 10, 2008 Contacts/Locations and Study Status
15 November 26, 2008 Contacts/Locations and Study Status
16 December 9, 2008 Contacts/Locations and Study Status
17 December 16, 2008 Contacts/Locations, Groups and Interventions and Study Status
18 January 5, 2009 Contacts/Locations, Groups and Interventions and Study Status
19 January 27, 2009 Contacts/Locations and Study Status
20 February 27, 2009 Contacts/Locations and Study Status
21 March 27, 2009 Contacts/Locations and Study Status
22 April 27, 2009 Contacts/Locations and Study Status
23 May 28, 2009 Contacts/Locations and Study Status
24 June 25, 2009 Contacts/Locations and Study Status
25 July 23, 2009 Contacts/Locations and Study Status
26 August 20, 2009 Contacts/Locations and Study Status
27 September 17, 2009 Contacts/Locations and Study Status
28 October 15, 2009 Contacts/Locations and Study Status
29 November 13, 2009 Contacts/Locations, Study Status, Conditions and Study Description
30 December 11, 2009 Contacts/Locations and Study Status
31 January 11, 2010 Contacts/Locations and Study Status
32 February 10, 2010 Contacts/Locations and Study Status
33 March 9, 2010 Contacts/Locations, Study Status and Study Description
34 April 6, 2010 Contacts/Locations and Study Status
35 May 6, 2010 Contacts/Locations and Study Status
36 June 7, 2010 Contacts/Locations and Study Status
37 July 7, 2010 Contacts/Locations and Study Status
38 August 3, 2010 Contacts/Locations and Study Status
39 September 2, 2010 Contacts/Locations and Study Status
40 September 7, 2010 Contacts/Locations and Study Status
41 October 5, 2010 Contacts/Locations and Study Status
42 November 4, 2010 Contacts/Locations and Study Status
43 November 10, 2010 Sponsor/Collaborators, Study Identification and Study Status
44 December 3, 2010 Contacts/Locations, Study Status and Outcome Measures
45 January 3, 2011 Contacts/Locations, Study Status, Outcome Measures and Conditions
46 February 3, 2011 Contacts/Locations and Study Status
47 March 6, 2011 Contacts/Locations, Study Status, Conditions and Sponsor/Collaborators
48 April 4, 2011 Contacts/Locations, Study Status, Conditions and Sponsor/Collaborators
49 May 4, 2011 Contacts/Locations and Study Status
50 June 3, 2011 Study Status, Contacts/Locations and Sponsor/Collaborators
51 June 30, 2011 Contacts/Locations, Sponsor/Collaborators and Study Status
52 July 29, 2011 Contacts/Locations, Study Status and Sponsor/Collaborators
53 August 29, 2011 Contacts/Locations, Sponsor/Collaborators and Study Status
54 September 29, 2011 Contacts/Locations, Study Status and Sponsor/Collaborators
55 October 27, 2011 Study Status and Contacts/Locations
56 November 23, 2011 Contacts/Locations and Study Status
57 December 21, 2011 Contacts/Locations and Study Status
58 January 20, 2012 Contacts/Locations and Study Status
59 February 16, 2012 Contacts/Locations and Study Status
60 March 15, 2012 Contacts/Locations and Study Status
61 April 13, 2012 Study Status and Contacts/Locations
62 May 10, 2012 Contacts/Locations and Study Status
63 June 8, 2012 Contacts/Locations and Study Status
64 July 5, 2012 Study Status and Contacts/Locations
65 August 1, 2012 Contacts/Locations and Study Status
66 August 29, 2012 Contacts/Locations and Study Status
67 September 28, 2012 Contacts/Locations and Study Status
68 October 26, 2012 Contacts/Locations and Study Status
69 November 15, 2012 Contacts/Locations and Study Status
70 December 12, 2012 Study Status and Contacts/Locations
71 January 6, 2013 Study Status
72 February 6, 2013 Study Status
73 March 4, 2013 Study Status
74 April 1, 2013 Contacts/Locations and Study Status
75 April 29, 2013 Contacts/Locations and Study Status
76 May 28, 2013 Contacts/Locations and Study Status
77 June 24, 2013 Contacts/Locations and Study Status
78 July 23, 2013 Contacts/Locations and Study Status
79 August 22, 2013 Study Status
80 September 20, 2013 Study Status
81 October 17, 2013 Study Status
82 November 7, 2013 Study Status
83 December 3, 2013 Study Status
84 December 30, 2013 Study Status
85 January 23, 2014 Study Status
86 February 20, 2014 Contacts/Locations and Study Status
87 March 4, 2014 Study Status and Contacts/Locations
88 April 9, 2014 Recruitment Status, Contacts/Locations and Study Status
89 May 12, 2014 Study Status
90 June 12, 2014 Recruitment Status, Contacts/Locations and Study Status
91 July 10, 2014 Study Status
92 August 5, 2014 Study Status
93 August 26, 2014 Contacts/Locations and Study Status
94 September 10, 2014 Study Status and Contacts/Locations
95 October 9, 2014 Recruitment Status, Contacts/Locations, Study Status and Study Identification
96 November 3, 2014 Study Status
97 January 29, 2015 Recruitment Status, Contacts/Locations and Study Status
98 February 9, 2015 Study Status
99 April 9, 2015 Contacts/Locations and Study Status
100 July 27, 2015 Contacts/Locations and Study Status
101 November 2, 2015 Recruitment Status, Contacts/Locations, Study Status and Study Design
102 November 11, 2015 Recruitment Status, Study Status and Contacts/Locations
103 December 11, 2015 Study Status and Study Design
104 March 7, 2016 Contacts/Locations, Study Status and Study Design
105 April 28, 2016 Recruitment Status, Contacts/Locations and Study Status
106 June 3, 2016 Recruitment Status, Contacts/Locations and Study Status
107 September 7, 2016 Contacts/Locations and Study Status
108 December 5, 2016 Study Status
109 February 23, 2017 Study Status and Contacts/Locations
110 May 17, 2017 Study Status and Contacts/Locations
111 June 28, 2017 Study Status
112 August 16, 2017 Contacts/Locations, Study Design and Study Status
113 September 1, 2017 Study Status
114 November 1, 2017 Contacts/Locations and Study Status
115 November 20, 2017 Contacts/Locations and Study Status
116 November 28, 2017 Groups and Interventions and Study Status
117 January 29, 2018 Contacts/Locations and Study Status
118 September 12, 2018 Oversight, Contacts/Locations and Study Status
119 December 28, 2018 Study Status, IPDSharing and Study Identification
120 February 21, 2019 Study Status and Contacts/Locations
121 March 13, 2019 Recruitment Status and Study Status
122 April 24, 2019 Study Status and Study Design
123 June 10, 2019 Contacts/Locations, Study Status
Show
Results Submission Events
124 March 24, 2020 Study Status, Outcome Measures, Document Section and Results
125 October 12, 2022 Contacts/Locations, Study Status, References and Study Design
Comparison Format:

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Study NCT00665561
Submitted Date:  April 23, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: A4001067
Brief Title: Prospective Observational Epidemiologic Study of Maraviroc's Safety (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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2008
Overall Status: Not yet recruiting
Study Start: April 2008
Primary Completion:
Study Completion: October 2015 [Anticipated]
First Submitted: April 23, 2008
First Submitted that
Met QC Criteria:
April 23, 2008
First Posted: April 24, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 23, 2008
Last Update Posted: April 24, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief 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.
Detailed Description: All patients meeting the study eligibility criteria at participating sites will be invited to participate.
Open or close this module Conditions
Conditions: Human Immunodeficiency Virus
Keywords: Maraviroc, HIV-1, Safety, Non-interventional
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 3000 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Maraviroc exposed
Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
Maraviroc unexposed
Drug: Optimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths
[ Time Frame: Followed till 6 months after drug discontinuation up to a total of 5 years. ]

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

Secondary Outcome Measures:
1. There are no Secondary Outcomes for this study.
[ Time Frame: 0 ]

Open or close this module Eligibility
Study Population: Treatment experienced, HIV-1 infected patients in routine clinical practice.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:

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