Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00830804
First received: January 26, 2009
Last updated: December 7, 2011
Last verified: December 2011
Results First Received: September 7, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infections
Interventions: Drug: Raltegravir
Drug: Darunavir/Ritonavir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were recruited from 22 U.S. sites from April 2009 to August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study participants were HIV-1-infected, antiretroviral(ARV)-naive men and women, 18 years and older with plasma HIV-1 RNA >= 5000 copies/ml. One enrolled participant never started study treatment.

Reporting Groups
  Description
RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Participant Flow:   Overall Study
    RAL + DRV/RTV  
STARTED     112 [1]
COMPLETED     97  
NOT COMPLETED     15  
Lost to Follow-up                 4  
Death                 1  
Unable to get to clinic                 7  
Consent withdrawn                 2  
Unwilling to adhere to study requirement                 1  
[1] 113 subjects enrolled. One subject never started study treatment and was excluded in all analysis.



  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
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Baseline Measures
    RAL+DRV/RTV  
Number of Participants  
[units: participants]
  112  
Age [1]
[units: years]
Median ( Full Range )
  36  
  ( 19 to 66 )  
Age, Customized [1]
[units: participants]
 
18-29     33  
30-39     38  
40-49     25  
50-59     12  
60-69     4  
Gender  
[units: participants]
 
Female     14  
Male     98  
Region of Enrollment  
[units: participants]
 
United States     112  
Puerto Rico     0  
[1] Age (in years) of participants at study entry



  Outcome Measures
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1.  Primary:   Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24   [ Time Frame: From start of study treatment to week 24 ]

Measure Type Primary
Measure Title Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24
Measure Description Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
Time Frame From start of study treatment to week 24  
Safety Issue No  

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.
All participants who started study treatment were included. The intent-to-treat approach was used, ignoring whether a participant was on or off treatment at the time of HIV-1 RNA measurement and censoring follow-up if a participant was lost-to-follow-up without previously meeting the definition of virologic failure.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  112  
Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24  
[units: Proportion of participants]
Number ( 95% Confidence Interval )
  0.16  
  ( 0.10 to 0.24 )  

No statistical analysis provided for Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24



2.  Secondary:   Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24   [ Time Frame: From start of study treatment to Week 24 ]

Measure Type Secondary
Measure Title Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24
Measure Description The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
Time Frame From start of study treatment to Week 24  
Safety Issue No  

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.
All participants who started study treatment were included in the analysis.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  112  
Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24  
[units: Proportion of participants]
Number ( 95% Confidence Interval )
  0.21  
  ( 0.14 to 0.29 )  

No statistical analysis provided for Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24



3.  Secondary:   Change in Plasma HIV-1 RNA From Baseline to Week 1   [ Time Frame: Baseline and week 1 ]

Measure Type Secondary
Measure Title Change in Plasma HIV-1 RNA From Baseline to Week 1
Measure Description Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.
Time Frame Baseline and week 1  
Safety Issue No  

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.
Analyis was based on an intent-to-treat approach, ignoring whether a participant was on or off study treatment at the time the sample for HIV-1 RNA was obtained.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  112  
Change in Plasma HIV-1 RNA From Baseline to Week 1  
[units: log10 copies/ml]
Median ( Inter-Quartile Range )
  -1.67  
  ( -1.93 to -1.42 )  

No statistical analysis provided for Change in Plasma HIV-1 RNA From Baseline to Week 1



4.  Secondary:   Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24   [ Time Frame: From start of study treatment to week 24 ]

Measure Type Secondary
Measure Title Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24
Measure Description Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.
Time Frame From start of study treatment to week 24  
Safety Issue No  

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.
All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off-study or with missing HIV-1 RNA at week 24.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  107  
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24  
[units: proportion of participants]
Number ( 95% Confidence Interval )
 
With HIV-1 RNA < 50 copies/ml     0.79  
  ( 0.70 to 0.86 )  
With HIV-1 RNA < 200 copies/ml     0.93  
  ( 0.87 to 0.97 )  

No statistical analysis provided for Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24



5.  Secondary:   Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48   [ Time Frame: From start of study treatment to week 48 ]

Measure Type Secondary
Measure Title Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48
Measure Description Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.
Time Frame From start of study treatment to week 48  
Safety Issue No  

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.
All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off study treatment or with missing HIV-1 RNA at week 48.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  100  
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48  
[units: proportion of participants]
Number ( 95% Confidence Interval )
 
With HIV-1 RNA < 50 copies/ml     0.71  
  ( 0.61 to 0.79 )  
With HIV-1 RNA < 200 copies/ml     0.86  
  ( 0.78 to 0.92 )  

No statistical analysis provided for Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48



6.  Secondary:   Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment   [ Time Frame: From start of study treatment to week 52 ]

Measure Type Secondary
Measure Title Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment
Measure Description Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.
Time Frame From start of study treatment to week 52  
Safety Issue Yes  

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.
All participants who started study treatment were included in the analysis.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  112  
Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment  
[units: proportion of participants]
Number ( 95% Confidence Interval )
  0.20  
  ( 0.13 to 0.28 )  

No statistical analysis provided for Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment



7.  Secondary:   Number of Participants With Pretreatment Drug Resistance   [ Time Frame: At screening ]

Measure Type Secondary
Measure Title Number of Participants With Pretreatment Drug Resistance
Measure Description Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.
Time Frame At screening  
Safety Issue No  

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.
All participants who started study treatment were included in the analysis.

Reporting Groups
  Description
RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL + DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  112  
Number of Participants With Pretreatment Drug Resistance  
[units: participants]
 
With NNRTI mutations only     9  
With NRTI mutations only     8  
With Both NNRTI and NRTI mutations     1  
With PI mutations only     2  
With PI, NNRTI and NRTI mutations     1  
No Resistance Detected     91  

No statistical analysis provided for Number of Participants With Pretreatment Drug Resistance



8.  Secondary:   Number of Participants With Integrase Drug Resistance at Virologic Failure   [ Time Frame: From 12 weeks after starting study treatment to week 52 ]

Measure Type Secondary
Measure Title Number of Participants With Integrase Drug Resistance at Virologic Failure
Measure Description Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.
Time Frame From 12 weeks after starting study treatment to week 52  
Safety Issue No  

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.
Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful integrase genotyping at failure were included in the analysis.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  25  
Number of Participants With Integrase Drug Resistance at Virologic Failure  
[units: participants]
  5  

No statistical analysis provided for Number of Participants With Integrase Drug Resistance at Virologic Failure



9.  Secondary:   Number of Participants With Protease Drug Resistance at Virologic Failure   [ Time Frame: From 12 weeks after starting study treatment to week 52 ]

Measure Type Secondary
Measure Title Number of Participants With Protease Drug Resistance at Virologic Failure
Measure Description Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.
Time Frame From 12 weeks after starting study treatment to week 52  
Safety Issue No  

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.
Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful protease genotyping at failure were included in the analysis.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  23  
Number of Participants With Protease Drug Resistance at Virologic Failure  
[units: participants]
  0  

No statistical analysis provided for Number of Participants With Protease Drug Resistance at Virologic Failure



10.  Secondary:   Number of Participants With Perfect Overall Adherence by Self Report   [ Time Frame: From one week after starting study treatment to week 52 ]

Measure Type Secondary
Measure Title Number of Participants With Perfect Overall Adherence by Self Report
Measure Description At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall "perfect" adherence.
Time Frame From one week after starting study treatment to week 52  
Safety Issue No  

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.
All participants who started study treatment were included in the analysis.

Reporting Groups
  Description
RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL + DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  112  
Number of Participants With Perfect Overall Adherence by Self Report  
[units: participants]
  95  

No statistical analysis provided for Number of Participants With Perfect Overall Adherence by Self Report



11.  Secondary:   Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24   [ Time Frame: From start of study treatment through week 24 ]

Measure Type Secondary
Measure Title Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24
Measure Description Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.
Time Frame From start of study treatment through week 24  
Safety Issue No  

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.
Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.

Reporting Groups
  Description
RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL + DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  94  
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24  
[units: mg/dL]
Median ( Inter-Quartile Range )
 
Fasting Total Cholesterol     31.5  
  ( 12 to 46 )  
Fasting High-density Lipoprotein     6.5  
  ( 1 to 15 )  
Fasting Triglyceride     24.5  
  ( -6 to 64 )  

No statistical analysis provided for Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24



12.  Secondary:   Change in Fasting Low-density Lipoprotein at Week 24   [ Time Frame: From start of study treatment through week 24 ]

Measure Type Secondary
Measure Title Change in Fasting Low-density Lipoprotein at Week 24
Measure Description Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.
Time Frame From start of study treatment through week 24  
Safety Issue No  

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.
Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.

Reporting Groups
  Description
RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL + DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  82  
Change in Fasting Low-density Lipoprotein at Week 24  
[units: mg/dL]
Median ( Inter-Quartile Range )
  16.0  
  ( 5 to 36 )  

No statistical analysis provided for Change in Fasting Low-density Lipoprotein at Week 24



13.  Secondary:   Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48   [ Time Frame: From start of study treatment through week 48 ]

Measure Type Secondary
Measure Title Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48
Measure Description Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.
Time Frame From start of study treatment through week 48  
Safety Issue No  

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.
Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.

Reporting Groups
  Description
RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL + DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  85  
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48  
[units: mg/dL]
Median ( Inter-Quartile Range )
 
Fasting Total Cholesterol     30  
  ( 10 to 59 )  
Fasting High-density Lipoprotein     9  
  ( 2 to 17 )  
Fasting Triglyceride     23  
  ( -31 to 81 )  

No statistical analysis provided for Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48



14.  Secondary:   Change in Fasting Low-density Lipoprotein at Week 48   [ Time Frame: From start of study treatment through week 48 ]

Measure Type Secondary
Measure Title Change in Fasting Low-density Lipoprotein at Week 48
Measure Description Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.
Time Frame From start of study treatment through week 48  
Safety Issue No  

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.
Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.

Reporting Groups
  Description
RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL + DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  70  
Change in Fasting Low-density Lipoprotein at Week 48  
[units: mg/dL]
Median ( Inter-Quartile Range )
  17  
  ( 2 to 33 )  

No statistical analysis provided for Change in Fasting Low-density Lipoprotein at Week 48



15.  Secondary:   Change in CD4 Count at Week 48   [ Time Frame: From start of study treatment through week 48 ]

Measure Type Secondary
Measure Title Change in CD4 Count at Week 48
Measure Description Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.
Time Frame From start of study treatment through week 48  
Safety Issue No  

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.
Only those participants who started study treatment and who have values at baseline and at week 48 were included in the analysis.

Reporting Groups
  Description
RAL + DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL + DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  100  
Change in CD4 Count at Week 48  
[units: cells/mm3]
Median ( Inter-Quartile Range )
  200  
  ( 114 to 318 )  

No statistical analysis provided for Change in CD4 Count at Week 48



16.  Secondary:   Plasma Trough Concentration of Raltegravir   [ Time Frame: From start of study treatment to week 52 ]

Measure Type Secondary
Measure Title Plasma Trough Concentration of Raltegravir
Measure Description Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.
Time Frame From start of study treatment to week 52  
Safety Issue No  

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.
Participants who started study treatment and who have at least one RAL plasma trough concentration obtained within 9-15 hours after the last RAL dose were included in the analysis.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  103  
Plasma Trough Concentration of Raltegravir  
[units: ng/ml]
Median ( Inter-Quartile Range )
  117  
  ( 52 to 250 )  

No statistical analysis provided for Plasma Trough Concentration of Raltegravir



17.  Secondary:   Plasma Trough Concentration of Darunavir   [ Time Frame: From start of study treatment to week 52 ]

Measure Type Secondary
Measure Title Plasma Trough Concentration of Darunavir
Measure Description Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.
Time Frame From start of study treatment to week 52  
Safety Issue No  

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.
Participants who started study treatment and who have at least one DRV plasma trough concentration obtained within 20-28 hours after the last DRV dose were included in the analysis.

Reporting Groups
  Description
RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Measured Values
    RAL+DRV/RTV  
Number of Participants Analyzed  
[units: participants]
  83  
Plasma Trough Concentration of Darunavir  
[units: ng/ml]
Median ( Inter-Quartile Range )
  1218  
  ( 789 to 1809 )  

No statistical analysis provided for Plasma Trough Concentration of Darunavir




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
This is a single-arm study.


  More Information