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Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine

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ClinicalTrials.gov Identifier: NCT00737568
Recruitment Status : Completed
First Posted : August 19, 2008
Results First Posted : April 11, 2013
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis B
Interventions Drug: TDF
Drug: FTC/TDF
Drug: TDF Placebo
Drug: FTC/TDF Placebo
Enrollment 280
Recruitment Details Participants were enrolled at study sites in North America, Europe, and New Zealand. The first participant was screened on 30 September 2008. The last study visit occurred on 09 February 2015.
Pre-assignment Details 752 participants were screened. Randomization was stratified by hepatitis B e antigen (HBeAg) status (negative or positive) and alanine aminotransferase (ALT) level (≥ 2 × upper limit of normal [ULN] or < 2 × ULN) at screening.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Period Title: Treatment Period Through Week 240
Started 141 139
Completed 121 118
Not Completed 20 21
Reason Not Completed
Investigator’s Discretion             6             5
Withdrew Consent             5             6
Safety, Tolerability, or Efficacy Reason             3             4
Lost to Follow-up             3             3
Protocol Violation             2             3
Study Discontinued by Sponsor             1             0
Period Title: Treatment-Free Follow-up (TFFU) Period
Started 38 [1] 37 [2]
Completed 12 19
Not Completed 26 18
Reason Not Completed
Started Commercial Therapy             25             17
Death             0             1
Withdrew Consent             1             0
[1]
1 participant not completing the 240 week treatment period enrolled in the TFFU period.
[2]
4 participants not completing the 240 week treatment period enrolled in the TFFU period.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF Total
Hide Arm/Group Description TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily Total of all reporting groups
Overall Number of Baseline Participants 141 139 280
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants 139 participants 280 participants
47.1  (13.63) 46.3  (13.56) 46.7  (13.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 139 participants 280 participants
Female
37
  26.2%
32
  23.0%
69
  24.6%
Male
104
  73.8%
107
  77.0%
211
  75.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 139 participants 280 participants
Hispanic or Latino
2
   1.4%
1
   0.7%
3
   1.1%
Not Hispanic or Latino
138
  97.9%
137
  98.6%
275
  98.2%
Unknown or Not Reported
1
   0.7%
1
   0.7%
2
   0.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 141 participants 139 participants 280 participants
Asian 52 42 94
Black or African American 3 1 4
Native Hawaiian or Other Pacific Islander 0 3 3
White 83 89 172
Other 3 4 7
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 141 participants 139 participants 280 participants
Austria 2 3 5
Bulgaria 2 5 7
Canada 47 43 90
Czech Republic 9 7 16
Germany 2 0 2
Greece 2 1 3
Hungary 4 3 7
New Zealand 7 10 17
Poland 13 19 32
Romania 17 14 31
Serbia 17 19 36
Spain 1 1 2
Turkey 15 13 28
United States 3 1 4
ALT Normal at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 141 participants 139 participants 280 participants
Abnormal 79 83 162
Normal 62 56 118
[1]
Measure Description: The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.
Hepatitis B Virus (HBV) DNA Level at Baseline  
Mean (Standard Deviation)
Unit of measure:  Log_10 copies/mL
Number Analyzed 141 participants 139 participants 280 participants
6.40  (1.826) 6.53  (1.968) 6.46  (1.896)
HBV e Antigen (HBeAg) Status at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 141 participants 139 participants 280 participants
Negative 76 71 147
Positive 65 68 133
1.Primary Outcome
Title Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: percentage of participants
89.4 86.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, FTC/Tenofovir DF
Comments The null hypothesis is that there is no difference between the FTC/TDF and TDF treatment groups. The alternative hypothesis is that there is a difference between the FTC/TDF and TDF treatment groups. These hypotheses were evaluated using a Cochran-Mantel-Haenszel (CMH) test, controlling for randomization strata, with the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments The p-value for the two-sided Cochran-Mantel-Haenszel test was controlled for strata (HBeAg status and ALT level).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240
Hide Description [Not Specified]
Time Frame Weeks 48, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, missing = failure method
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 81.6 84.2
Week 144 87.2 84.9
Week 192 86.5 85.6
Week 240 83.0 82.7
3.Secondary Outcome
Title Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240
Hide Description [Not Specified]
Time Frame Weeks 48, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, missing = failure method
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 76.6 77.7
Week 96 85.8 83.5
Week 144 86.5 84.9
Week 192 85.1 84.2
Week 240 81.6 82.0
4.Secondary Outcome
Title HBV DNA Level at Weeks 48, 96, 144, 192, and 240
Hide Description [Not Specified]
Time Frame Weeks 48, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Week 48 (TDF: n=130; FTC/TDF: n=133) 2.42  (0.542) 2.48  (0.887)
Week 96 (TDF: n=132; FTC/TDF: n=127) 2.29  (0.254) 2.28  (0.241)
Week 144 (TDF: n=128; FTC/TDF: n=123) 2.26  (0.173) 2.29  (0.541)
Week 192 (TDF: n=126; FTC/TDF: n=119) 2.25  (0.135) 2.23  (0.027)
Week 240 (TDF: n=118; FTC/TDF: n=116) 2.23  (0.052) 2.26  (0.376)
5.Secondary Outcome
Title Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240
Hide Description Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.
Time Frame Weeks 48, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, missing = failure method
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 67.4 69.8
Week 96 70.2 69.8
Week 144 70.2 75.5
Week 192 75.9 76.3
Week 240 71.6 71.9
6.Secondary Outcome
Title Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240
Hide Description The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.
Time Frame Baseline; Weeks 48, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 65 68
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 9.2 5.9
Week 96 15.4 13.2
Week 144 23.1 17.6
Week 192 21.5 14.7
Week 240 24.6 19.1
7.Secondary Outcome
Title Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240
Hide Description The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.
Time Frame Baseline; Weeks 48, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 65 68
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 6.2 4.4
Week 96 10.8 10.3
Week 144 12.3 11.8
Week 192 10.8 10.3
Week 240 12.3 10.3
8.Secondary Outcome
Title Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240
Hide Description The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.
Time Frame Baseline; Weeks 48, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, missing = failure method
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 0.0 0.7
Week 96 0.0 0.7
Week 144 0.7 1.4
Week 192 0.7 2.9
Week 240 1.4 2.9
9.Secondary Outcome
Title Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240
Hide Description The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.
Time Frame Baseline; Weeks 48, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, missing = failure method
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 0.0 0.0
Week 96 0.0 0.0
Week 144 0.0 0.7
Week 192 0.0 0.7
Week 240 0.0 0.7
10.Secondary Outcome
Title Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240
Hide Description The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being < 400 copies/mL.
Time Frame Baseline; Weeks 48, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 (TDF: n=130; FTC/TDF: n=133) 0.0 0.8
Week 96 (TDF: n=132; FTC/TDF: n=127) 0.0 0.0
Week 144 (TDF: n=128; FTC/TDF: n=123) 0.8 0.8
Week 192 (TDF: n=126; FTC/TDF: n=119) 0.8 0.0
Week 240 (TDF: n=118; FTC/TDF: n=116) 0.0 0.0
11.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240
Hide Description BMD is calculated as grams per cubic centimeter (g/cm^2); the mean (SD) percentage change is presented.
Time Frame Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) with spine BMD measurements at the given time point were included in the analysis.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: percentage change
% Change at Week 24 (TDF: n=132; FTC/TDF: n=127) -1.74  (2.867) -1.83  (2.565)
% Change at Week 48 (TDF: n=126; FTC/TDF: n=121) -1.68  (3.094) -1.73  (2.944)
% Change at Week 72 (TDF: n=123; FTC/TDF: n=119) -1.35  (3.337) -1.95  (2.977)
% Change at Week 96 (TDF: n=126; FTC/TDF: n=114) -1.24  (3.761) -1.72  (3.269)
% Change at Week 144 (TDF: n=123; FTC/TDF: n=110) -1.36  (3.810) -1.63  (3.591)
% Change at Week 192 (TDF: n=120; FTC/TDF: n=106) -1.32  (4.237) -1.60  (4.628)
% Change at Week 240 (TDF: n=115; FTC/TDF: n=102) -0.83  (4.490) -1.15  (5.130)
12.Secondary Outcome
Title Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240
Hide Description BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.
Time Frame Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with hip BMD measurements at the given time point were included in the analysis.
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: percentage change
% Change at Week 24 (TDF: n=130; FTC/TDF: n=127) -0.71  (1.724) -0.59  (1.835)
% Change at Week 48 (TDF: n=126; FTC/TDF: n=118) -1.15  (2.120) -1.00  (2.063)
% Change at Week 72 (TDF: n=121; FTC/TDF: n=115) -1.59  (2.507) -1.61  (2.525)
% Change at Week 96 (TDF: n=125; FTC/TDF: n=112) -1.70  (2.617) -1.77  (2.801)
% Change at Week 144 (TDF: n=120; FTC/TDF: n=107) -2.02  (3.030) -1.91  (3.281)
% Change at Week 192 (TDF: n=116; FTC/TDF: n=105) -2.33  (3.190) -2.41  (3.783)
% Change at Week 240 (TDF: n=111; FTC/TDF: n=100) -2.46  (3.191) -2.63  (3.872)
13.Secondary Outcome
Title Development of Drug-resistant Mutations (DRMs)
Hide Description The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.
Time Frame Baseline to Week 240
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description:
TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: participants
New tenofovir DF DRMs 0 0
Enrichment of tenofovir DF DRMs 0 0
New FTC DRMs 0 0
Enrichment of FTC DRMs 0 1
Time Frame Baseline through end of study drug treatment (average exposure 220 weeks) plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
 
Arm/Group Title Tenofovir DF FTC/Tenofovir DF
Hide Arm/Group Description TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
All-Cause Mortality
Tenofovir DF FTC/Tenofovir DF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tenofovir DF FTC/Tenofovir DF
Affected / at Risk (%) Affected / at Risk (%)
Total   23/141 (16.31%)   21/139 (15.11%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/141 (0.71%)  0/139 (0.00%) 
Neutropenia  1  1/141 (0.71%)  0/139 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/141 (0.71%)  0/139 (0.00%) 
Angina pectoris  1  1/141 (0.71%)  0/139 (0.00%) 
Coronary artery stenosis  1  0/141 (0.00%)  1/139 (0.72%) 
Myocardial ischaemia  1  1/141 (0.71%)  0/139 (0.00%) 
Ear and labyrinth disorders     
Middle ear inflammation  1  0/141 (0.00%)  1/139 (0.72%) 
Tympanic membrane perforation  1  0/141 (0.00%)  1/139 (0.72%) 
Gastrointestinal disorders     
Abdominal pain  1  0/141 (0.00%)  1/139 (0.72%) 
Diarrhoea  1  0/141 (0.00%)  1/139 (0.72%) 
Gastritis  1  1/141 (0.71%)  1/139 (0.72%) 
Inguinal hernia  1  1/141 (0.71%)  0/139 (0.00%) 
General disorders     
Chest pain  1  1/141 (0.71%)  0/139 (0.00%) 
Pyrexia  1  1/141 (0.71%)  1/139 (0.72%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/141 (0.71%)  0/139 (0.00%) 
Cholelithiasis  1  0/141 (0.00%)  1/139 (0.72%) 
Infections and infestations     
Abdominal infection  1  0/141 (0.00%)  1/139 (0.72%) 
Acarodermatitis  1  1/141 (0.71%)  0/139 (0.00%) 
Appendicitis  1  0/141 (0.00%)  1/139 (0.72%) 
Bone tuberculosis  1  0/141 (0.00%)  1/139 (0.72%) 
Bronchopneumonia  1  0/141 (0.00%)  1/139 (0.72%) 
Pharyngotonsillitis  1  1/141 (0.71%)  0/139 (0.00%) 
Pneumonia  1  1/141 (0.71%)  1/139 (0.72%) 
Sepsis  1  0/141 (0.00%)  1/139 (0.72%) 
Urinary tract infection  1  0/141 (0.00%)  1/139 (0.72%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/141 (0.71%)  0/139 (0.00%) 
Fall  1  0/141 (0.00%)  1/139 (0.72%) 
Fibula fracture  1  1/141 (0.71%)  0/139 (0.00%) 
Tendon injury  1  1/141 (0.71%)  0/139 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/141 (0.71%)  3/139 (2.16%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  0/141 (0.00%)  1/139 (0.72%) 
Osteoarthritis  1  0/141 (0.00%)  2/139 (1.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/141 (0.71%)  0/139 (0.00%) 
Adenolymphoma  1  0/141 (0.00%)  1/139 (0.72%) 
Adrenal adenoma  1  0/141 (0.00%)  1/139 (0.72%) 
Adrenal neoplasm  1  0/141 (0.00%)  1/139 (0.72%) 
Bladder neoplasm  1  1/141 (0.71%)  0/139 (0.00%) 
Hepatocellular carcinoma  1  2/141 (1.42%)  1/139 (0.72%) 
Lung neoplasm malignant  1  0/141 (0.00%)  1/139 (0.72%) 
Lymphoma  1  1/141 (0.71%)  0/139 (0.00%) 
Oesophageal adenocarcinoma  1  0/141 (0.00%)  1/139 (0.72%) 
Oesophageal carcinoma  1  1/141 (0.71%)  0/139 (0.00%) 
Pancreatic carcinoma  1  0/141 (0.00%)  1/139 (0.72%) 
Plasma cell myeloma  1  0/141 (0.00%)  1/139 (0.72%) 
Prostate cancer  1  1/141 (0.71%)  0/139 (0.00%) 
Thyroid cancer  1  1/141 (0.71%)  0/139 (0.00%) 
Tumour haemorrhage  1  0/141 (0.00%)  1/139 (0.72%) 
Psychiatric disorders     
Depression  1  0/141 (0.00%)  1/139 (0.72%) 
Renal and urinary disorders     
Calculus ureteric  1  1/141 (0.71%)  0/139 (0.00%) 
Haematuria  1  2/141 (1.42%)  0/139 (0.00%) 
Nephrolithiasis  1  1/141 (0.71%)  0/139 (0.00%) 
Urinary retention  1  1/141 (0.71%)  0/139 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/141 (0.71%)  0/139 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  1/141 (0.71%)  0/139 (0.00%) 
Vascular disorders     
Venous thrombosis limb  1  0/141 (0.00%)  1/139 (0.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tenofovir DF FTC/Tenofovir DF
Affected / at Risk (%) Affected / at Risk (%)
Total   109/141 (77.30%)   105/139 (75.54%) 
Gastrointestinal disorders     
Abdominal pain  1  6/141 (4.26%)  7/139 (5.04%) 
Abdominal pain upper  1  8/141 (5.67%)  12/139 (8.63%) 
Diarrhoea  1  13/141 (9.22%)  7/139 (5.04%) 
Nausea  1  12/141 (8.51%)  11/139 (7.91%) 
General disorders     
Fatigue  1  14/141 (9.93%)  15/139 (10.79%) 
Pyrexia  1  8/141 (5.67%)  5/139 (3.60%) 
Immune system disorders     
Seasonal allergy  1  8/141 (5.67%)  3/139 (2.16%) 
Infections and infestations     
Influenza  1  14/141 (9.93%)  10/139 (7.19%) 
Nasopharyngitis  1  24/141 (17.02%)  20/139 (14.39%) 
Investigations     
Creatinine renal clearance decreased  1  2/141 (1.42%)  7/139 (5.04%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/141 (1.42%)  7/139 (5.04%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/141 (7.09%)  18/139 (12.95%) 
Back pain  1  10/141 (7.09%)  15/139 (10.79%) 
Musculoskeletal pain  1  5/141 (3.55%)  7/139 (5.04%) 
Myalgia  1  7/141 (4.96%)  8/139 (5.76%) 
Pain in extremity  1  4/141 (2.84%)  8/139 (5.76%) 
Nervous system disorders     
Dizziness  1  7/141 (4.96%)  8/139 (5.76%) 
Headache  1  23/141 (16.31%)  20/139 (14.39%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  12/141 (8.51%)  13/139 (9.35%) 
Oropharyngeal pain  1  12/141 (8.51%)  3/139 (2.16%) 
Vascular disorders     
Hypertension  1  7/141 (4.96%)  9/139 (6.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
There were no limitations affecting the analysis or results.
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
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Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00737568     History of Changes
Other Study ID Numbers: GS-US-174-0121
First Submitted: August 15, 2008
First Posted: August 19, 2008
Results First Submitted: November 15, 2012
Results First Posted: April 11, 2013
Last Update Posted: March 11, 2016