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Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil

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ClinicalTrials.gov Identifier: NCT00307489
Recruitment Status : Completed
First Posted : March 28, 2006
Results First Posted : July 7, 2009
Last Update Posted : November 1, 2011
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Hepatitis B
Interventions Drug: tenofovir DF
Drug: emtricitabine /tenofovir DF
Enrollment 106
Recruitment Details A total of 106 subjects were randomized (105 of which were subsequently treated) across 28 study centers in the US, Germany, France and Spain between 24 April 2006 and 07 March 2007.
Pre-assignment Details  
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description tenofovir DF 300 mg QD emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Period Title: Baseline Through Week 48
Started 53 52
Completed 52 [1] 50 [2]
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             0             1
Physician Decision             1             0
Withdrawal by Subject             0             1
[1]
16 of the 52 subjects switched to open-label FTC/TDF prior to Week 48.
[2]
9 of the 50 subjects switched to open-label FTC/TDF prior to Week 48.
Period Title: Week 48 Through Week 168
Started 52 50
Completed 46 [1] 44 [2]
Not Completed 6 6
Reason Not Completed
Adverse Event             1             0
Physician Decision             1             0
Withdrawal by Subject             1             2
Lack of Efficacy             2             2
Death             0             1
Lost to Follow-up             0             1
Seroconversion             1             0
[1]
11 of the 46 subjects switched to open-label FTC/TDF prior to Week 168.
[2]
5 of the 44 subjects switched to open-label FTC/TDF prior to Week 168.
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF Total
Hide Arm/Group Description tenofovir DF 300 mg QD emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet) Total of all reporting groups
Overall Number of Baseline Participants 53 52 105
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 52 participants 105 participants
40  (11.4) 39  (10.4) 39  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 52 participants 105 participants
Female
15
  28.3%
10
  19.2%
25
  23.8%
Male
38
  71.7%
42
  80.8%
80
  76.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 52 participants 105 participants
Asian 26 18 44
Black or African American 2 8 10
White 23 21 44
Other 2 5 7
Previous Lamivudine Experience  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 52 participants 105 participants
Yes 30 31 61
No 23 21 44
Baseline HBV DNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 53 participants 52 participants 105 participants
6.06  (1.430) 5.87  (1.779) 5.97  (1.607)
1.Primary Outcome
Title Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized and Treated (RAT) subjects at Week 48 - Non-Completers=Failure (ie, includes subjects who switched to open-label FTC/TDF at or after Week 24)
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Unit of Measure: percentage of participants
75.5 69.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .544
Comments P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set Non-Completers=Failure
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Unit of Measure: percentage of participants
81.1 80.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.988
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in log10 Plasma HBV DNA Levels at Week 48
Hide Description [Not Specified]
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 52 50
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.58  (1.290) -3.34  (1.753)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.208
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method van Elteren
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48
Hide Description [Not Specified]
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: U/mL
-21.6  (54.53) -41.4  (151.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.712
Comments Controlling for baseline HBeAg and prior lamivudine use.
Method van Elteren
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 48
Hide Description ULN for males = 43 U/L; 34 U/L for females
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set Non-Completers=Failure
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 51 52
Measure Type: Number
Unit of Measure: percentage of participants
66.7 73.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.423
Comments Controlling for baseline HBeAg status and prior lamivudine use
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 48
Hide Description Subjects with elevated ALT at baseline that return to normal by Week 48.
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set - subjects with ALT above ULN at baseline. Non-Completers=Failure
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 27 26
Measure Type: Number
Unit of Measure: percentage of participants
40.7 61.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Hepatitis B Early Antigen (HBeAg) Loss at Week 48
Hide Description Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline.
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set with Positive HBeAg at Baseline. Non-Completers=Failure
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: participants
3 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.952
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for baseline HBeAg and prior lamivudine use.
8.Secondary Outcome
Title HBeAg Seroconversion at Week 48
Hide Description Defined as having negative serum HBeAg and positive serum antibody to HBeAg [anti-HBe] for subjects with positive serum HBeAg at baseline.
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set with Positive Baseline HBeAg. Non-Completers=Failure
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: participants
2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.655
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
9.Secondary Outcome
Title HBsAg Loss at Week 48
Hide Description Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set Non-Completers=Failure
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 53 51
Measure Type: Number
Unit of Measure: participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48
Hide Description Defined as having negative serum HBsAg and positive serum antibody to HBsAg [anti-HBs] for subject with positive serum HBsAg at baseline.
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RAT Analysis Set Non-Completers=Failure
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 53 51
Measure Type: Number
Unit of Measure: participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in log10 Plasma HBV DNA Levels at Week 168
Hide Description [Not Specified]
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Non-completers = failure analysis
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 53 52
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.79  (1.305) -3.48  (1.629)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method van Elteren
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168
Hide Description [Not Specified]
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Non-completers = failure analysis
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 53 52
Mean (Standard Deviation)
Unit of Measure: U/mL
-26.8  (60.23) -54.5  (141.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method van Elteren
Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
Hide Description [Not Specified]
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Non-completers = failure analysis
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Unit of Measure: Percent of Participants
82.4 84.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.781
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 168
Hide Description ULN for males = 43 U/L; ULN for females = 34 U/L
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Non-completers = failure analysis
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Percent of Participants
74.0 74.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.936
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 168
Hide Description Subjects with elevated ALT at baseline that return to normal by Week 48.
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: Percent of Participants
68.0 70.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.784
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
16.Secondary Outcome
Title Hepatitis B Early Antigen (HBeAg) Loss at Week 168
Hide Description Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline.
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Non-completer = Failure Analysis
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 37 37
Measure Type: Number
Unit of Measure: Percent of Participants
21.6 24.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.703
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
17.Secondary Outcome
Title Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168
Hide Description Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline.
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Non-completer = Failure Analysis
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
18.Secondary Outcome
Title HBsAg Loss at Week 168
Hide Description Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments Controlling for baseline HBeAg status and prior lamivudine use.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168
Hide Description P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.
Time Frame 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Non-completers = failure analysis
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description:
tenofovir DF 300 mg QD
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
Overall Number of Participants Analyzed 51 50
Measure Type: Number
Unit of Measure: Percent of Participants
80.4 78.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Emtricitibine/Tenofovir DF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.878
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame 168 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tenofovir DF Emtricitibine/Tenofovir DF
Hide Arm/Group Description tenofovir DF 300 mg QD emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
All-Cause Mortality
Tenofovir DF Emtricitibine/Tenofovir DF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tenofovir DF Emtricitibine/Tenofovir DF
Affected / at Risk (%) Affected / at Risk (%)
Total   6   10 
Blood and lymphatic system disorders     
Anaemia   1/53 (1.89%)  0/52 (0.00%) 
Cardiac disorders     
Atrial Fibrillation *  0/53 (0.00%)  1/52 (1.92%) 
Gastrointestinal disorders     
Colitis ulcerative *  1/53 (1.89%)  0/52 (0.00%) 
General disorders     
Chest Pain * 1  1/53 (1.89%)  0/52 (0.00%) 
Oedema Peripheral * 1  1/53 (1.89%)  0/52 (0.00%) 
Infections and infestations     
Appendicitis *  0/53 (0.00%)  1/52 (1.92%) 
Chronic Sinusitis * 1  0/53 (0.00%)  1/52 (1.92%) 
Gastroenteritis *  1/53 (1.89%)  0/52 (0.00%) 
Sepsis *  0/53 (0.00%)  1/52 (1.92%) 
Investigations     
Alanine Aminotransferase Increased  1  0/53 (0.00%)  2/52 (3.85%) 
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Protrusion *  0/53 (0.00%)  1/52 (1.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Fibroadenoma of Breast *  0/53 (0.00%)  1/52 (1.92%) 
Lymphoma *  0/53 (0.00%)  1/52 (1.92%) 
Waldenstrom's Macroglobulinaemia *  1/53 (1.89%)  0/52 (0.00%) 
Nervous system disorders     
Carotid Arteriosclerosis *  1/53 (1.89%)  0/52 (0.00%) 
Cerebrovascular Accident * 1  0/53 (0.00%)  1/52 (1.92%) 
Hemiparesis * 1  0/53 (0.00%)  1/52 (1.92%) 
Pain *  0/53 (0.00%)  1/52 (1.92%) 
Psychiatric disorders     
Alcoholism * 1  0/53 (0.00%)  1/52 (1.92%) 
Renal and urinary disorders     
Renal failure *  0/53 (0.00%)  1/52 (1.92%) 
Reproductive system and breast disorders     
Bartholinitis *  0/53 (0.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/53 (1.89%)  0/52 (0.00%) 
Respiratory failure *  0/53 (0.00%)  1/52 (1.92%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tenofovir DF Emtricitibine/Tenofovir DF
Affected / at Risk (%) Affected / at Risk (%)
Total   49   42 
Blood and lymphatic system disorders     
Anaemia   3/53 (5.66%)  1/52 (1.92%) 
Gastrointestinal disorders     
Abdominal Pain * 1  5/53 (9.43%)  5/52 (9.62%) 
Abdominal Pain Upper * 1  8/53 (15.09%)  9/52 (17.31%) 
Constipation *  2/53 (3.77%)  3/52 (5.77%) 
Diarrhoea * 1  5/53 (9.43%)  3/52 (5.77%) 
Dyspepsia *  4/53 (7.55%)  2/52 (3.85%) 
Haemorrhoids *  3/53 (5.66%)  1/52 (1.92%) 
Nausea * 1  5/53 (9.43%)  2/52 (3.85%) 
Gastroenteritis *  3/53 (5.66%)  1/52 (1.92%) 
General disorders     
Asthenia * 1  7/53 (13.21%)  2/52 (3.85%) 
Fatigue * 1  9/53 (16.98%)  9/52 (17.31%) 
Immune system disorders     
Seasonal allergy *  2/53 (3.77%)  3/52 (5.77%) 
Infections and infestations     
Bronchitis *  3/53 (5.66%)  7/52 (13.46%) 
Influenza *  3/53 (5.66%)  1/52 (1.92%) 
Nasopharyngitis * 1  16/53 (30.19%)  12/52 (23.08%) 
Upper respiratory tract infection *  1/53 (1.89%)  3/52 (5.77%) 
Urinary Tract Infection * 1  5/53 (9.43%)  4/52 (7.69%) 
Investigations     
Blood Creatine Phosphokinase Increased  1  0/53 (0.00%)  4/52 (7.69%) 
Alanine Aminotransferase Increased   0/53 (0.00%)  3/52 (5.77%) 
Metabolism and nutrition disorders     
Decreased appetite *  3/53 (5.66%)  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  2/53 (3.77%)  5/52 (9.62%) 
Back Pain *  9/53 (16.98%)  6/52 (11.54%) 
Myalgia *  3/53 (5.66%)  1/52 (1.92%) 
Pain in Extremity *  2/53 (3.77%)  4/52 (7.69%) 
Nervous system disorders     
Dizziness * 1  4/53 (7.55%)  4/52 (7.69%) 
Headache * 2  15/53 (28.30%)  10/52 (19.23%) 
Paraesthesia *  0/53 (0.00%)  3/52 (5.77%) 
Psychiatric disorders     
Depression *  1/53 (1.89%)  3/52 (5.77%) 
Insomnia *  1/53 (1.89%)  3/52 (5.77%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  3/53 (5.66%)  1/52 (1.92%) 
Pharyngolaryngeal Pain * 1  8/53 (15.09%)  3/52 (5.77%) 
Skin and subcutaneous tissue disorders     
Alopecia *  3/53 (5.66%)  1/52 (1.92%) 
Pruritis *  3/53 (5.66%)  2/52 (3.85%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
2
Term from vocabulary, Dizziness
The randomized and treated (RAT) analysis set includes all subjects who were ongoing at the time of analysis (i.e., those on blinded therapy and those who switched to open-label FTC/TDFdue to persistent viremia).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen J. Rossi, PharmD
Organization: Gilead Sciences, Inc.
Phone: 650-522-4212
EMail: stephen.rossi@gilead.com
Publications of Results:
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00307489     History of Changes
Other Study ID Numbers: GS-US-174-0106
First Submitted: March 24, 2006
First Posted: March 28, 2006
Results First Submitted: January 30, 2009
Results First Posted: July 7, 2009
Last Update Posted: November 1, 2011