Trial Outcomes & Findings for Safety and Efficacy Study of Switching From Epzicom to Truvada (NCT NCT00724711)

Last Updated: 2012-05-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

312 participants

Primary outcome timeframe

Baseline to 48 weeks

Results posted on

2012-05-28

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	155	156
Overall Study COMPLETED	138	139
Overall Study NOT COMPLETED	17	17

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	7	3
Overall Study Pregnancy	0	1
Overall Study Lack of Efficacy	0	1
Overall Study Physician Decision	0	3
Overall Study Withdrawal by Subject	5	4
Overall Study Lost to Follow-up	4	5
Overall Study Protocol Violation	1	0

Baseline Characteristics

Safety and Efficacy Study of Switching From Epzicom to Truvada

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: Baseline to 48 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	TVD + PI/r n=154 Participants 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 n=156 Participants 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.
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	86.4 percentage of participants	83.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: ITT Analysis Set

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.

Outcome measures

Outcome measures
Measure	TVD + PI/r n=154 Participants 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 n=156 Participants 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.
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48	99.2 percentage of participants Interval 94.8 to 99.9	97.2 percentage of participants Interval 92.7 to 98.9

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: ITT Analysis Set

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.

Outcome measures

Outcome measures
Measure	TVD + PI/r n=154 Participants 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 n=156 Participants 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.
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48	93.0 percentage of participants Interval 87.3 to 96.2	91.1 percentage of participants Interval 85.1 to 94.7

SECONDARY outcome

Timeframe: 48 weeks

Population: 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

The percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 was summarized.

Outcome measures

Outcome measures
Measure	TVD + PI/r n=154 Participants 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 n=156 Participants 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.
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 On-Treatment Response Analysis (Missing = Failure)	84.4 percentage of participants	82.1 percentage of participants
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 Snapshot Responder Analysis (Virologic Success)	84.4 percentage of participants	82.1 percentage of participants

SECONDARY outcome

Timeframe: 48 weeks

Population: 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

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was summarized.

Outcome measures

Outcome measures
Measure	TVD + PI/r n=154 Participants 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 n=156 Participants 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.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 TLOVR Responder Analysis	77.9 percentage of participants	76.3 percentage of participants
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 On-Treatment Response Analysis (Missing = Failure)	79.9 percentage of participants	77.6 percentage of participants
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Snapshot Responder Analysis (Virologic Success)	79.9 percentage of participants	77.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: ITT Analysis Set Missing = Excluded: Participants with missing values were excluded from this analysis

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=135 Participants 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 n=138 Participants 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.
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48	8 cells/microliter Standard Deviation 148.3	34 cells/microliter Standard Deviation 150.1

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: 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.

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=137 Participants 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 n=139 Participants 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.
Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48	-8.4 mL/min Standard Deviation 12.18	-4.1 mL/min Standard Deviation 12.99

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: Treated Analysis Set

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=137 Participants 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 n=139 Participants 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.
Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48	-9.0 mL/min/1.73m^2 Standard Deviation 14.10	-3.7 mL/min/1.73m^2 Standard Deviation 15.75

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: Treated Analysis Set

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=134 Participants 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 n=135 Participants 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.
Change From Baseline Fasting Glucose at Week 48	1 mg/dL Standard Deviation 23.1	1 mg/dL Standard Deviation 16.8

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: Treated Analysis Set

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=135 Participants 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 n=136 Participants 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.
Change From Baseline Fasting Lipid Parameters at Week 48 Total Cholesterol	-21 mg/dL Standard Deviation 38.6	-4 mg/dL Standard Deviation 37.9
Change From Baseline Fasting Lipid Parameters at Week 48 LDL (low-density lipoprotein)	-6 mg/dL Standard Deviation 33.2	2 mg/dL Standard Deviation 30.0
Change From Baseline Fasting Lipid Parameters at Week 48 HDL (high-density lipoprotein)	-2 mg/dL Standard Deviation 10.7	0 mg/dL Standard Deviation 11.3
Change From Baseline Fasting Lipid Parameters at Week 48 Triglycerides	-51 mg/dL Standard Deviation 174.0	-23 mg/dL Standard Deviation 178.3

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: Treated Analysis Set

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=135 Participants 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 n=136 Participants 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.
Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48	-0.1 Ratio Standard Deviation 2.58	-0.1 Ratio Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3 Missing = Excluded

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=69 Participants 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 n=57 Participants 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.
Change From Baseline C-Reactive Protein at Week 48	-0.026 mg/dL Standard Deviation 0.4029	0.225 mg/dL Standard Deviation 1.2787

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3 Missing = Excluded

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=64 Participants 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 n=56 Participants 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.
Change From Baseline Fibrinogen at Week 48	-4 mg/dL Standard Deviation 77.0	14 mg/dL Standard Deviation 91.8

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: Treated Analysis Set, Subset of Participants Enrolled after Amendment 3 Missing = Excluded

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	TVD + PI/r n=68 Participants 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 n=56 Participants 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.
Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 TNF-alpha	0.0 pg/mL Standard Deviation 2.06	4.7 pg/mL Standard Deviation 23.95
Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 IL-10	0.0 pg/mL Standard Deviation 1.69	-0.2 pg/mL Standard Deviation 1.41
Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 IL-6	-0.2 pg/mL Standard Deviation 4.10	-0.6 pg/mL Standard Deviation 5.96

Adverse Events

TVD + PI/r

Serious events: 12 serious events

Other events: 35 other events

Deaths: 0 deaths

ABC/3TC + PI/r

Serious events: 11 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	TVD + PI/r n=155 participants at risk 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 n=156 participants at risk 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.
Gastrointestinal disorders Diarrhea	8.4% 13/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	7.1% 11/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Infections and infestations Upper Respiratory Tract Infection	9.0% 14/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	9.0% 14/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Nervous system disorders Headache	5.2% 8/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	3.2% 5/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Respiratory, thoracic and mediastinal disorders Cough	5.2% 8/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	5.1% 8/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.

Additional Information

Dara Wambach, MA, Associate Director, Regulatory Affairs

Gilead Sciences

Phone: 650 522 5163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER

Measure	TVD + PI/r n=155 participants at risk 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 n=156 participants at risk 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.
Cardiac disorders Myocardial Infarction	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Cardiac disorders Bradycardia	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Gastrointestinal disorders Pancreatitis	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Gastrointestinal disorders Gastritis	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Gastrointestinal disorders Rectal Haemorrhage	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
General disorders Chest Pain	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Infections and infestations Cellulitis	1.9% 3/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Infections and infestations Giardiasis	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Infections and infestations Influenza	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Infections and infestations Pneumonia	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Infections and infestations Streptococcal Sepsis	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Infections and infestations Shunt Infection	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Injury, poisoning and procedural complications Intentional Overdose	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Injury, poisoning and procedural complications Burns Third Degree	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Metabolism and nutrition disorders Dehydration	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse Large B-Cell Lymphoma	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Nervous system disorders Dizziness	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Psychiatric disorders Depression	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Psychiatric disorders Hallucination, Auditory	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Psychiatric disorders Completed Suicide	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Renal and urinary disorders Renal Failure	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	1.3% 2/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Skin and subcutaneous tissue disorders Urticaria	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Vascular disorders Deep Vein Thrombosis	0.65% 1/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.00% 0/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Vascular disorders Venous Thrombosis Limb	0.00% 0/155 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.	0.64% 1/156 • AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.