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

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ClinicalTrials.gov Identifier: NCT01190124
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : May 19, 2011
Last Update Posted : May 19, 2011
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Eurotrials Brasil Consultores Cientificos Ltda
Information provided by:
Doroana, Maria Manuela, M.D.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition HIV Infections
Enrollment 151
Recruitment Details 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 197 patients were included in the database. However, only 151 patients were included in the analysis, as 46 did not meet inclusion/exclusion criteria
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Hide Arm/Group Description Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL) 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) Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Period Title: Overall Study
Started 107 24 20
Completed 90 24 19
Not Completed 17 0 1
Reason Not Completed
Death             3             0             0
Therapeutic Failure             12             0             1
Lost to Follow-up             2             0             0
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure Total
Hide Arm/Group Description Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL) 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) Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment) Total of all reporting groups
Overall Number of Baseline Participants 107 24 20 151
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 107 participants 24 participants 20 participants 151 participants
44.0
(30 to 77)
45.5
(25 to 72)
52.5
(27 to 65)
45.0
(25 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 24 participants 20 participants 151 participants
Female
22
  20.6%
5
  20.8%
10
  50.0%
37
  24.5%
Male
85
  79.4%
19
  79.2%
10
  50.0%
114
  75.5%
1.Primary Outcome
Title HIV-RNA Levels
Hide Description Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
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)
Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Overall Number of Participants Analyzed 107 24 20
Measure Type: Number
Unit of Measure: participants
< 50 copies/mL 0 24 10
>= 50 copies/mL 107 0 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV-1 at Virologic Failure, HIV With Need for Therapy Change, HIV-2 With Therapeutic Failure
Comments Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning HIV-RNA levels at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title HIV-RNA Levels
Hide Description Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
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)
Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Overall Number of Participants Analyzed 107 24 20
Measure Type: Number
Unit of Measure: participants
< 50 copies / mL 75 24 17
>= 50 copies / mL 27 0 2
Missing value 5 0 1
3.Primary Outcome
Title HIV-RNA Levels
Hide Description Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
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)
Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Overall Number of Participants Analyzed 107 24 20
Measure Type: Number
Unit of Measure: participants
< 50 copies/mL 74 24 16
>= 50 copies/mL 18 0 3
Missing value 15 0 1
4.Primary Outcome
Title CD4 Cells Count
Hide Description CD4 cells count at baseline.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
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)
Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Overall Number of Participants Analyzed 107 24 20
Median (Full Range)
Unit of Measure: cells/mm^3
166.00
(3 to 856)
391
(120 to 925)
120
(15 to 430)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV-1 at Virologic Failure, HIV With Need for Therapy Change, HIV-2 With Therapeutic Failure
Comments Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Primary Outcome
Title CD4 Cells Count
Hide Description CD4 cells count at week 24.
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
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)
Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Overall Number of Participants Analyzed 107 24 20
Median (Full Range)
Unit of Measure: cells/mm^3
299.50
(26 to 1409)
389.00
(171 to 864)
190.00
(57 to 591)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV-1 at Virologic Failure, HIV With Need for Therapy Change, HIV-2 With Therapeutic Failure
Comments Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
6.Primary Outcome
Title CD4 Cells Count
Hide Description CD4 cells count at week 48.
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
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)
Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
Overall Number of Participants Analyzed 107 24 20
Median (Full Range)
Unit of Measure: cells/mm^3
336.50
(18 to 29760)
452.00
(170 to 823)
180.00
(49 to 703)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV-1 at Virologic Failure, HIV With Need for Therapy Change, HIV-2 With Therapeutic Failure
Comments Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
7.Secondary Outcome
Title HIV-RNA Levels
Hide Description For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Patients With Therapy Replacement
Hide Arm/Group Description:
HIV infected patients in whom T20 was replaced by raltegravir
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
< 50 copies/mL 20
>= 50 copies/mL 0
8.Secondary Outcome
Title HIV-RNA Levels
Hide Description For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Patients With Therapy Replacement
Hide Arm/Group Description:
HIV infected patients in whom T20 was replaced by raltegravir
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
< 50 copies/mL 20
>= 50 copies/mL 0
9.Secondary Outcome
Title HIV-RNA Levels
Hide Description For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Patients With Therapy Replacement
Hide Arm/Group Description:
HIV infected patients in whom T20 was replaced by raltegravir
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
< 50 copies/mL 20
>= 50 copies/mL 0
10.Secondary Outcome
Title CD4 Cells Count
Hide Description For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Patients With Therapy Replacement
Hide Arm/Group Description:
HIV infected patients in whom T20 was replaced by raltegravir
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: cells/mm^3
400.50
(120 to 925)
11.Secondary Outcome
Title CD4 Cells Count
Hide Description For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Patients With Therapy Replacement
Hide Arm/Group Description:
HIV infected patients in whom T20 was replaced by raltegravir
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: cells/mm^3
378.00
(171 to 864)
12.Secondary Outcome
Title CD4 Cells Count
Hide Description For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Patients With Therapy Replacement
Hide Arm/Group Description:
HIV infected patients in whom T20 was replaced by raltegravir
Overall Number of Participants Analyzed 107
Median (Full Range)
Unit of Measure: cells/mm^3
452.00
(170 to 823)
13.Secondary Outcome
Title CD4 Cells Count
Hide Description For the HIV-2 infected patients CD4 cells count will be assessed at baseline.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult HIV-2 infected patients with therapeutic failure
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: cells/mm^3
120.00
(15 to 430)
14.Secondary Outcome
Title CD4 Cells Count
Hide Description For the HIV-2 infected patients CD4 cells count will be assessed at week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult HIV-2 infected patients with therapeutic failure
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: cells/mm^3
190.00
(57 to 591)
15.Secondary Outcome
Title CD4 Cells Count
Hide Description For the HIV-2 infected patients CD4 cells count will be assessed at week 48.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult HIV-2 infected patients with therapeutic failure
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: cells/mm^3
180.00
(49 to 703)
16.Secondary Outcome
Title HIV-RNA Levels
Hide Description For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult HIV-2 infected patients with therapeutic failure
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
< 50 copies/mL 10
>= 50 copies/mL 10
17.Secondary Outcome
Title HIV-RNA Levels
Hide Description For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult HIV-2 infected patients with therapeutic failure
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
< 50 copies/mL 17
>= 50 copies/mL 2
Missing value 1
18.Secondary Outcome
Title HIV-RNA Levels
Hide Description For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-2 With Therapeutic Failure
Hide Arm/Group Description:
Adult HIV-2 infected patients with therapeutic failure
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
< 50 copies/mL 16
>= 50 copies/mL 3
Missing value 1
19.Secondary Outcome
Title Adverse Drug Reactions
Hide Description Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total
Hide Arm/Group Description:
Total number of patients studied
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: participants
At least one adverse reaction 12
At least one non serious adverse reaction 9
At least one serious adverse reaction 3
Patients that discontinued due to adverse reaction 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Hide Arm/Group Description Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL) 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) Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
All-Cause Mortality
HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/107 (2.80%)      0/24 (0.00%)      0/20 (0.00%)    
Skin and subcutaneous tissue disorders       
Toxidermia  1/107 (0.93%)  1 0/24 (0.00%)  0 0/20 (0.00%)  0
Surgical and medical procedures       
Anemia  1/107 (0.93%)  1 0/24 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders       
Edema of the lower extremities  1/107 (0.93%)  1 0/24 (0.00%)  0 0/20 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV-1 at Virologic Failure HIV With Need for Therapy Change HIV-2 With Therapeutic Failure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/107 (6.54%)      1/24 (4.17%)      1/20 (5.00%)    
Blood and lymphatic system disorders       
Anemia  1/107 (0.93%)  1 0/24 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders       
Diarrhea  2/107 (1.87%)  2 0/24 (0.00%)  0 0/20 (0.00%)  0
Metabolism and nutrition disorders       
Elevated CPK  1/107 (0.93%)  1 0/24 (0.00%)  0 1/20 (5.00%)  1
Elevated AST/ALT  0/107 (0.00%)  0 1/24 (4.17%)  1 0/20 (0.00%)  0
Nervous system disorders       
Somnolence  2/107 (1.87%)  2 0/24 (0.00%)  0 0/20 (0.00%)  0
Psychiatric disorders       
Hallucinations  1/107 (0.93%)  1 0/24 (0.00%)  0 0/20 (0.00%)  0
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
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
First Submitted: August 25, 2010
First Posted: August 27, 2010
Results First Submitted: January 3, 2011
Results First Posted: May 19, 2011
Last Update Posted: May 19, 2011