Safety and Efficacy Study of Switching From Epzicom to Truvada (SWIFT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00724711
First received: July 25, 2008
Last updated: May 22, 2012
Last verified: May 2012
Results First Received: March 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)
Drug: abacavir (ABC)/lamivudine (3TC)

  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
Participants were enrolled at a total of 76 study sites; 70 in the US, 3 in Canada, and 3 in Puerto Rico. The first participant was screened on 15 August 2008, and the last participant was randomized on 27 April 2010. Last participant observation (LPO) date was 19 April 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 393 subjects were screened for entry into this study, and 312 subjects were randomized (156 to each treatment group). One participant randomized to the TVD+PI/r group was never treated.

Reporting Groups
  Description
FTC/TDF (Truvada [TVD]) + PI/r (Ritonavir-boosted PI Regimen) Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
Abacavir (ABC) /Lamivudine (3TC) + PI/r (Ritonavir-boosted PI) Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Participant Flow:   Overall Study
    FTC/TDF (Truvada [TVD]) + PI/r (Ritonavir-boosted PI Regimen)     Abacavir (ABC) /Lamivudine (3TC) + PI/r (Ritonavir-boosted PI)  
STARTED     155     156  
COMPLETED     138     139  
NOT COMPLETED     17     17  
Adverse Event                 7                 3  
Pregnancy                 0                 1  
Lack of Efficacy                 0                 1  
Physician Decision                 0                 3  
Withdrawal by Subject                 5                 4  
Lost to Follow-up                 4                 5  
Protocol Violation                 1                 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
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
Total Total of all reporting groups

Baseline Measures
    TVD + PI/r     ABC/3TC + PI/r     Total  
Number of Participants  
[units: participants]
  155     156     311  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 9.0     47  ± 9.7     46  ± 9.3  
Gender  
[units: participants]
     
Female     26     22     48  
Male     129     134     263  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     4     3     7  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     43     44     87  
White     96     106     202  
Other     12     3     15  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic/Latino     38     36     74  
Non-Hispanic/Latino     117     120     237  
Region of Enrollment  
[units: participants]
     
United States     146     142     288  
Puerto Rico     4     5     9  
Canada     5     9     14  
Weight  
[units: kg]
Mean ± Standard Deviation
  82.2  ± 17.40     82.5  ± 15.65     82.3  ± 16.52  
Height  
[units: cm]
Mean ± Standard Deviation
  173.8  ± 9.52     174.1  ± 9.55     173.9  ± 9.52  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  27.3  ± 5.96     27.2  ± 4.93     27.3  ± 5.46  



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Baseline to 48 weeks ]

Measure Type Primary
Measure Title Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
Measure Description The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.
Time Frame Baseline to 48 weeks  
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.
Intent-to-treat (ITT) Analysis Set: Participants who were treated with at least one dose of study drug with no documented resistance to study drug prior to screening.

Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  154     156  
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm  
[units: percentage of participants]
  86.4     83.3  


Statistical Analysis 1 for Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Inverted two one-sided tests
Difference in percentages between groups [4] 3.0
95% Confidence Interval ( -5.1 to 11.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

Null hypothesis: The TVD group is at least 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA < 200 copies/mL through Week 48 (“responder rate”, as defined by the TLOVR algorithm)

Alternative hypothesis: The TVD group is less than 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA < 200 copies/mL through Week 48 (“responder rate”, as defined by the TLOVR algorithm)

[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
 

This study was designed to show noninferiority (change of < 12%) in regard of proportions of responders (TLOVR) at Week 48.

With 170 subjects in each group, the lower limit of observed one-sided 97.5% confidence interval was expected to be greater than −0.120 with 80% power when the proportion of responders in both treatment groups is 0.820 (82%) at Week 48.

312 subjects were enrolled, representing 8% less than planned (n = 340). As a result, power to claim non-inferiority decreased to 78%.

[3] Other relevant method information, such as adjustments or degrees of freedom:
  Inverted two one-sided tests with the standardized statistic
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
Measure Description The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.
Time Frame Baseline to 48 weeks  
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.
ITT Analysis Set

Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  154     156  
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48  
[units: percentage of participants]
  99.2     97.2  

No statistical analysis provided for Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48



3.  Secondary:   Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
Measure Description The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study.
Time Frame Baseline to 48 weeks  
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.
ITT Analysis Set

Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  154     156  
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48  
[units: percentage of participants]
  93.0     91.1  

No statistical analysis provided for Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48



4.  Secondary:   Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48   [ Time Frame: 48 weeks ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
Measure Description The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized.
Time Frame 48 weeks  
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.

ITT analysis set

Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 200 copies/mL

Virologic Success: Last available HIV-1 RNA < 200 copies/mL in the Week 48 window while on randomized treatment


Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  154     156  
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48  
[units: percentage of participants]
   
On-Treatment Response Analysis (Missing = Failure)     84.4     82.1  
Snapshot Responder Analysis (Virologic Success)     84.4     82.1  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48



5.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ Time Frame: 48 weeks ]

Measure Type Secondary
Measure Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Measure Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized.
Time Frame 48 weeks  
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.

ITT analysis set

TLOVR: No virologic rebound on or before Week 48; no discontinuation before Week 48; no new ARV by study completion

Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 50 copies/mL

Virologic Success: Last available HIV-1 RNA < 50 copies/mL in Week 48 window on randomized treatment


Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  154     156  
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48  
[units: percentage of participants]
   
TLOVR Responder Analysis     77.9     76.3  
On-Treatment Response Analysis (Missing = Failure)     79.9     77.6  
Snapshot Responder Analysis (Virologic Success)     79.9     77.6  

No statistical analysis provided for Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48



6.  Secondary:   Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.

ITT Analysis Set

Missing = Excluded: Participants with missing values were excluded from this analysis


Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  135     138  
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48  
[units: cells/microliter]
Mean ± Standard Deviation
  8  ± 148.3     34  ± 150.1  

No statistical analysis provided for Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48



7.  Secondary:   Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.
Treated Analysis Set: The treated analysis set included all randomized participants who received at least one dose of study drug. Participants who were randomized to continue ABC/3TC+PI/r during the study were included in the treated analysis set if they took at least one dose of their study drug after the baseline visit.

Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  137     139  
Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48  
[units: mL/min]
Mean ± Standard Deviation
  -8.4  ± 12.18     -4.1  ± 12.99  

No statistical analysis provided for Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48



8.  Secondary:   Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.
Treated Analysis Set

Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  137     139  
Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48  
[units: mL/min/1.73m^2]
Mean ± Standard Deviation
  -9.0  ± 14.10     -3.7  ± 15.75  

No statistical analysis provided for Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48



9.  Secondary:   Change From Baseline Fasting Glucose at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline Fasting Glucose at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.
Treated Analysis Set

Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  134     135  
Change From Baseline Fasting Glucose at Week 48  
[units: mg/dL]
Mean ± Standard Deviation
  1  ± 23.1     1  ± 16.8  

No statistical analysis provided for Change From Baseline Fasting Glucose at Week 48



10.  Secondary:   Change From Baseline Fasting Lipid Parameters at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline Fasting Lipid Parameters at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.
Treated Analysis Set

Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  135     136  
Change From Baseline Fasting Lipid Parameters at Week 48  
[units: mg/dL]
Mean ± Standard Deviation
   
Total Cholesterol     -21  ± 38.6     -4  ± 37.9  
LDL (low-density lipoprotein)     -6  ± 33.2     2  ± 30.0  
HDL (high-density lipoprotein)     -2  ± 10.7     0  ± 11.3  
Triglycerides     -51  ± 174.0     -23  ± 178.3  

No statistical analysis provided for Change From Baseline Fasting Lipid Parameters at Week 48



11.  Secondary:   Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.
Treated Analysis Set

Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  135     136  
Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48  
[units: Ratio]
Mean ± Standard Deviation
  -0.1  ± 2.58     -0.1  ± 1.03  

No statistical analysis provided for Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48



12.  Secondary:   Change From Baseline C-Reactive Protein at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline C-Reactive Protein at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.

Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3

Missing = Excluded


Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  69     57  
Change From Baseline C-Reactive Protein at Week 48  
[units: mg/dL]
Mean ± Standard Deviation
  -0.026  ± 0.4029     0.225  ± 1.2787  

No statistical analysis provided for Change From Baseline C-Reactive Protein at Week 48



13.  Secondary:   Change From Baseline Fibrinogen at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline Fibrinogen at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.

Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3

Missing = Excluded


Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  64     56  
Change From Baseline Fibrinogen at Week 48  
[units: mg/dL]
Mean ± Standard Deviation
  -4  ± 77.0     14  ± 91.8  

No statistical analysis provided for Change From Baseline Fibrinogen at Week 48



14.  Secondary:   Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48   [ Time Frame: Baseline to 48 weeks ]

Measure Type Secondary
Measure Title Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks  
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.

Treated Analysis Set, Subset of Participants Enrolled after Amendment 3

Missing = Excluded


Reporting Groups
  Description
TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.

Measured Values
    TVD + PI/r     ABC/3TC + PI/r  
Number of Participants Analyzed  
[units: participants]
  68     56  
Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48  
[units: pg/mL]
Mean ± Standard Deviation
   
IL-10     0.0  ± 1.69     -0.2  ± 1.41  
IL-6     -0.2  ± 4.10     -0.6  ± 5.96  
TNF-alpha     0.0  ± 2.06     4.7  ± 23.95  

No statistical analysis provided for Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48




  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
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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.


Results Point of Contact:  
Name/Title: Dara Wambach, MA, Associate Director, Regulatory Affairs
Organization: Gilead Sciences
phone: 650 522 5163
e-mail: Dara.Wambach@gilead.com


No publications provided by Gilead Sciences

Publications automatically indexed to this study:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00724711     History of Changes
Other Study ID Numbers: GS-US-164-0216
Study First Received: July 25, 2008
Results First Received: March 28, 2012
Last Updated: May 22, 2012
Health Authority: United States: Institutional Review Board