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
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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Consent withdrawn                 2  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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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 ]

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 ]

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

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 ]

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 ]

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

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

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

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

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 ]

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

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 ]

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

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

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


  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
This is a single-arm study.


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