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

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ClinicalTrials.gov Identifier: NCT00724711

Recruitment Status : Completed

First Posted : July 29, 2008

Results First Posted : April 19, 2012

Last Update Posted : May 28, 2012

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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.
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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
Overall Participants Analyzed [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 ]

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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 ]

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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 ]

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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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 ]

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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 ]

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9. Secondary:

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

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10. Secondary:

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

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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 ]

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12. Secondary:

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

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13. Secondary:

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

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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 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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:

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.

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.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Campo R, DeJesus E, Bredeek UF, Henry K, Khanlou H, Logue K, Brinson C, Benson P, Dau L, Wang H, White K, Flaherty J, Fralich T, Guyer B, Piontkowsky D. SWIFT: prospective 48-week study to evaluate efficacy and safety of switching to emtricitabine/tenofovir from lamivudine/abacavir in virologically suppressed HIV-1 infected patients on a boosted protease inhibitor containing antiretroviral regimen. Clin Infect Dis. 2013 Jun;56(11):1637-45. doi: 10.1093/cid/cis1203. Epub 2013 Jan 29. Erratum in: Clin Infect Dis. 2013 Sep;57(5):779.

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00724711 History of Changes
Other Study ID Numbers:	GS-US-164-0216
First Submitted:	July 25, 2008
First Posted:	July 29, 2008
Results First Submitted:	March 28, 2012
Results First Posted:	April 19, 2012
Last Update Posted:	May 28, 2012

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