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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
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
History of Changes
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
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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
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Consent withdrawn                 2  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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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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

3.  Secondary:   Change in Plasma HIV-1 RNA From Baseline to Week 1   [ Time Frame: Baseline and week 1 ]
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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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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

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

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

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 ]
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12.  Secondary:   Change in Fasting Low-density Lipoprotein at Week 24   [ Time Frame: From start of study treatment through week 24 ]
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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 ]
  Show Outcome Measure 13

14.  Secondary:   Change in Fasting Low-density Lipoprotein at Week 48   [ Time Frame: From start of study treatment through week 48 ]
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15.  Secondary:   Change in CD4 Count at Week 48   [ Time Frame: From start of study treatment through week 48 ]
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16.  Secondary:   Plasma Trough Concentration of Raltegravir   [ Time Frame: From start of study treatment to week 52 ]
  Show Outcome Measure 16

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

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
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications:

Publications automatically indexed to this study:


Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00830804     History of Changes
Other Study ID Numbers: ACTG A5262, 1U01AI068636
Study First Received: January 26, 2009
Results First Received: September 7, 2011
Last Updated: December 7, 2011
Health Authority: United States: Federal Government