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Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Eurotrials Brasil Consultores Cientificos Ltda
Information provided by:
Doroana, Maria Manuela, M.D.
ClinicalTrials.gov Identifier:
NCT01190124
First received: August 25, 2010
Last updated: April 20, 2011
Last verified: April 2011
Results First Received: January 3, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: HIV Infections

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Retrospective collection of data took place in 11 portuguese public hospitals. Each site included patients who started treatment with raltegravir from March 2007 until December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
197 patients were included in the database. However, only 151 patients were included in the analysis, as 46 did not meet inclusion/exclusion criteria

Reporting Groups
  Description
HIV-1 at Virologic Failure Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)

Participant Flow:   Overall Study
    HIV-1 at Virologic Failure   HIV With Need for Therapy Change   HIV-2 With Therapeutic Failure
STARTED   107   24   20 
COMPLETED   90   24   19 
NOT COMPLETED   17   0   1 
Death                3                0                0 
Therapeutic Failure                12                0                1 
Lost to Follow-up                2                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HIV-1 at Virologic Failure Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
HIV With Need for Therapy Change Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
HIV-2 With Therapeutic Failure Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Total Total of all reporting groups

Baseline Measures
   HIV-1 at Virologic Failure   HIV With Need for Therapy Change   HIV-2 With Therapeutic Failure   Total 
Overall Participants Analyzed 
[Units: Participants]
 107   24   20   151 
Age 
[Units: Years]
Median (Full Range)
 44.0 
 (30 to 77) 
 45.5 
 (25 to 72) 
 52.5 
 (27 to 65) 
 45.0 
 (25 to 77) 
Gender 
[Units: Participants]
       
Female   22   5   10   37 
Male   85   19   10   114 


  Outcome Measures
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1.  Primary:   HIV-RNA Levels   [ Time Frame: Baseline ]

2.  Primary:   HIV-RNA Levels   [ Time Frame: week 24 ]

3.  Primary:   HIV-RNA Levels   [ Time Frame: week 48 ]

4.  Primary:   CD4 Cells Count   [ Time Frame: Baseline ]

5.  Primary:   CD4 Cells Count   [ Time Frame: week 24 ]

6.  Primary:   CD4 Cells Count   [ Time Frame: week 48 ]

7.  Secondary:   HIV-RNA Levels   [ Time Frame: Baseline ]

8.  Secondary:   HIV-RNA Levels   [ Time Frame: Week 24 ]

9.  Secondary:   HIV-RNA Levels   [ Time Frame: Week 48 ]

10.  Secondary:   CD4 Cells Count   [ Time Frame: Baseline ]

11.  Secondary:   CD4 Cells Count   [ Time Frame: Week 24 ]

12.  Secondary:   CD4 Cells Count   [ Time Frame: Week 48 ]

13.  Secondary:   CD4 Cells Count   [ Time Frame: Baseline ]

14.  Secondary:   CD4 Cells Count   [ Time Frame: Week 24 ]

15.  Secondary:   CD4 Cells Count   [ Time Frame: Week 48 ]

16.  Secondary:   HIV-RNA Levels   [ Time Frame: Baseline ]

17.  Secondary:   HIV-RNA Levels   [ Time Frame: Week 24 ]

18.  Secondary:   HIV-RNA Levels   [ Time Frame: Week 48 ]

19.  Secondary:   Adverse Drug Reactions   [ Time Frame: Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Doroana, Maria Manuela, M.D.
Organization: Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
phone: 351 217938043
e-mail: manuela.doroana@hsm.min-saude.pt



Responsible Party: Maria Manuela Doroana, MD, Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
ClinicalTrials.gov Identifier: NCT01190124     History of Changes
Other Study ID Numbers: CohortHIV2008PT
Study First Received: August 25, 2010
Results First Received: January 3, 2011
Last Updated: April 20, 2011
Health Authority: Portugal: Health Ethic Committee