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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
  Show All Outcome Measures

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 ]

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 ]

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 ]

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

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

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

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 ]

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 ]

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

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 ]

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 ]

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

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

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 ]


  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
No text entered.


  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