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

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

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
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)

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 ]

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 ]