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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)
Enrollment 312
Recruitment Details 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 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.
Arm/Group Title FTC/TDF (Truvada [TVD]) + PI/r (Ritonavir-boosted PI Regimen) Abacavir (ABC) /Lamivudine (3TC) + PI/r (Ritonavir-boosted PI)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 155 156
Completed 138 139
Not Completed 17 17
Reason Not Completed
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
Arm/Group Title TVD + PI/r ABC/3TC + PI/r Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 155 156 311
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 156 participants 311 participants
46  (9.0) 47  (9.7) 46  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 156 participants 311 participants
Female
26
  16.8%
22
  14.1%
48
  15.4%
Male
129
  83.2%
134
  85.9%
263
  84.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 156 participants 311 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 156 participants 311 participants
Hispanic/Latino 38 36 74
Non-Hispanic/Latino 117 120 237
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 156 participants 311 participants
United States 146 142 288
Puerto Rico 4 5 9
Canada 5 9 14
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 155 participants 156 participants 311 participants
82.2  (17.40) 82.5  (15.65) 82.3  (16.52)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 155 participants 156 participants 311 participants
173.8  (9.52) 174.1  (9.55) 173.9  (9.52)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 155 participants 156 participants 311 participants
27.3  (5.96) 27.2  (4.93) 27.3  (5.46)
1.Primary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 156
Measure Type: Number
Unit of Measure: percentage of participants
86.4 83.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TVD + PI/r, ABC/3TC + PI/r
Comments

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)

Type of Statistical Test Non-Inferiority or Equivalence
Comments

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%.

Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Inverted two one-sided tests
Comments Inverted two one-sided tests with the standardized statistic
Method of Estimation Estimation Parameter Difference in percentages between groups
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-5.1 to 11.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 156
Measure Type: Number
Unit of Measure: percentage of participants
99.2 97.2
3.Secondary Outcome
Title Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 156
Measure Type: Number
Unit of Measure: percentage of participants
93.0 91.1
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
Hide Description The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 156
Measure Type: Number
Unit of Measure: percentage of participants
On-Treatment Response Analysis (Missing = Failure) 84.4 82.1
Snapshot Responder Analysis (Virologic Success) 84.4 82.1
5.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 154 156
Measure Type: Number
Unit of Measure: 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
6.Secondary Outcome
Title Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

ITT Analysis Set

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

Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 135 138
Mean (Standard Deviation)
Unit of Measure: cells/microliter
8  (148.3) 34  (150.1)
7.Secondary Outcome
Title Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 137 139
Mean (Standard Deviation)
Unit of Measure: mL/min
-8.4  (12.18) -4.1  (12.99)
8.Secondary Outcome
Title Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Analysis Set
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 137 139
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
-9.0  (14.10) -3.7  (15.75)
9.Secondary Outcome
Title Change From Baseline Fasting Glucose at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Analysis Set
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 134 135
Mean (Standard Deviation)
Unit of Measure: mg/dL
1  (23.1) 1  (16.8)
10.Secondary Outcome
Title Change From Baseline Fasting Lipid Parameters at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Analysis Set
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 135 136
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
11.Secondary Outcome
Title Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Analysis Set
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 135 136
Mean (Standard Deviation)
Unit of Measure: Ratio
-0.1  (2.58) -0.1  (1.03)
12.Secondary Outcome
Title Change From Baseline C-Reactive Protein at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3

Missing = Excluded

Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 69 57
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.026  (0.4029) 0.225  (1.2787)
13.Secondary Outcome
Title Change From Baseline Fibrinogen at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3

Missing = Excluded

Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 64 56
Mean (Standard Deviation)
Unit of Measure: mg/dL
-4  (77.0) 14  (91.8)
14.Secondary Outcome
Title Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
Hide Description Change = Week 48 value minus baseline value
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Treated Analysis Set, Subset of Participants Enrolled after Amendment 3

Missing = Excluded

Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 68 56
Mean (Standard Deviation)
Unit of Measure: pg/mL
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)
Time Frame AEs were reported in the during the randomized, open-label study period between Weeks 0 through 48.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TVD + PI/r ABC/3TC + PI/r
Hide Arm/Group Description 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. 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.
All-Cause Mortality
TVD + PI/r ABC/3TC + PI/r
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TVD + PI/r ABC/3TC + PI/r
Affected / at Risk (%) Affected / at Risk (%)
Total   12/155 (7.74%)   11/156 (7.05%) 
Cardiac disorders     
Myocardial Infarction  1/155 (0.65%)  0/156 (0.00%) 
Bradycardia  0/155 (0.00%)  1/156 (0.64%) 
Gastrointestinal disorders     
Pancreatitis  0/155 (0.00%)  1/156 (0.64%) 
Gastric Ulcer  0/155 (0.00%)  1/156 (0.64%) 
Gastritis  0/155 (0.00%)  1/156 (0.64%) 
Rectal Haemorrhage  1/155 (0.65%)  0/156 (0.00%) 
General disorders     
Chest Pain  0/155 (0.00%)  1/156 (0.64%) 
Infections and infestations     
Cellulitis  3/155 (1.94%)  0/156 (0.00%) 
Giardiasis  1/155 (0.65%)  0/156 (0.00%) 
Influenza  0/155 (0.00%)  1/156 (0.64%) 
Pneumonia  1/155 (0.65%)  0/156 (0.00%) 
Streptococcal Sepsis  1/155 (0.65%)  0/156 (0.00%) 
Shunt Infection  0/155 (0.00%)  1/156 (0.64%) 
Injury, poisoning and procedural complications     
Lower Limb Fracture  0/155 (0.00%)  1/156 (0.64%) 
Intentional Overdose  1/155 (0.65%)  0/156 (0.00%) 
Burns Third Degree  0/155 (0.00%)  1/156 (0.64%) 
Metabolism and nutrition disorders     
Hyperkalaemia  0/155 (0.00%)  1/156 (0.64%) 
Dehydration  0/155 (0.00%)  1/156 (0.64%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal Cancer  1/155 (0.65%)  0/156 (0.00%) 
Diffuse Large B-Cell Lymphoma  0/155 (0.00%)  1/156 (0.64%) 
Nervous system disorders     
Dizziness  0/155 (0.00%)  1/156 (0.64%) 
Pregnancy, puerperium and perinatal conditions     
Abortion Spontaneous  0/155 (0.00%)  1/156 (0.64%) 
Psychiatric disorders     
Depression  1/155 (0.65%)  0/156 (0.00%) 
Hallucination, Auditory  1/155 (0.65%)  0/156 (0.00%) 
Completed Suicide  1/155 (0.65%)  0/156 (0.00%) 
Renal and urinary disorders     
Renal Failure  0/155 (0.00%)  1/156 (0.64%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism  0/155 (0.00%)  2/156 (1.28%) 
Skin and subcutaneous tissue disorders     
Urticaria  1/155 (0.65%)  0/156 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis  1/155 (0.65%)  0/156 (0.00%) 
Venous Thrombosis Limb  0/155 (0.00%)  1/156 (0.64%) 
1
Term from vocabulary, MedDRA 14
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TVD + PI/r ABC/3TC + PI/r
Affected / at Risk (%) Affected / at Risk (%)
Total   35/155 (22.58%)   32/156 (20.51%) 
Gastrointestinal disorders     
Diarrhea  13/155 (8.39%)  11/156 (7.05%) 
Infections and infestations     
Upper Respiratory Tract Infection  14/155 (9.03%)  14/156 (8.97%) 
Nervous system disorders     
Headache  8/155 (5.16%)  5/156 (3.21%) 
Respiratory, thoracic and mediastinal disorders     
Cough  8/155 (5.16%)  8/156 (5.13%) 
1
Term from vocabulary, MedDRA 14
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.

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
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