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Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection

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ClinicalTrials.gov Identifier: NCT01651403
Recruitment Status : Active, not recruiting
First Posted : July 27, 2012
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis B Infection
Interventions Drug: Tenofovir DF
Drug: TDF Placebo
Enrollment 90
Recruitment Details Participants were enrolled at study sites in the United States, Asia, and Europe.The first participant was screened on 06 December 2012. The last Week 48 study visit occurred on 07 August 2017.
Pre-assignment Details 176 participants were screened.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description

Blinded Randomized Phase: Tenofovir disoproxil fumarate (TDF) tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)

Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.

Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)

Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.

Period Title: Overall Study
Started 60 30
Completed 5 1
Not Completed 55 29
Reason Not Completed
Continuing Study             48             22
Subject Noncompliance             1             1
Withdrew Consent/Assent             5             5
Investigator Decision             1             0
Subjects Randomized and Not Treated             0             1
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo Total
Hide Arm/Group Description

Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)

Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.

Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)

Open-Label Treatment Phase: After Week 72 (protocol amendment 2) or Week 48 (protocol amendment 3), participants switched to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Open-Label Extension Phase: After Week 192, participants are offered open-label TDF treatment until it was commercially available in that country for treatment of chronic HBV in individuals of their age and weight.

Total of all reporting groups
Overall Number of Baseline Participants 60 29 89
Hide Baseline Analysis Population Description
Safety Analysis Set: all randomized participants who have received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they received during the blinded phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 29 participants 89 participants
6  (2.5) 7  (3.2) 6  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 29 participants 89 participants
Female
27
  45.0%
12
  41.4%
39
  43.8%
Male
33
  55.0%
17
  58.6%
50
  56.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 29 participants 89 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
60
 100.0%
29
 100.0%
89
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 29 participants 89 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
41
  68.3%
17
  58.6%
58
  65.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   6.7%
1
   3.4%
5
   5.6%
White
15
  25.0%
11
  37.9%
26
  29.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 29 participants 89 participants
South Korea
23
  38.3%
11
  37.9%
34
  38.2%
Romania
13
  21.7%
10
  34.5%
23
  25.8%
United States
14
  23.3%
3
  10.3%
17
  19.1%
Taiwan
2
   3.3%
0
   0.0%
2
   2.2%
India
8
  13.3%
5
  17.2%
13
  14.6%
HBV DNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 60 participants 29 participants 89 participants
8.089  (0.7208) 8.133  (1.2538) 8.103  (0.9214)
Hepatitis B Virus Surface Antigen (HBsAg)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 29 participants 89 participants
Positive
60
 100.0%
29
 100.0%
89
 100.0%
Negative
0
   0.0%
0
   0.0%
0
   0.0%
Hepatitis B e antigen (HBeAg)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 29 participants 89 participants
Positive
56
  93.3%
29
 100.0%
85
  95.5%
Negative
4
   6.7%
0
   0.0%
4
   4.5%
HBeAb  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 29 participants 89 participants
Positive
4
   6.7%
0
   0.0%
4
   4.5%
Negative or Missing
56
  93.3%
29
 100.0%
85
  95.5%
Spine Bone Mineral Density  
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 60 participants 29 participants 89 participants
0.586  (0.1196) 0.626  (0.1567) 0.599  (0.1332)
1.Primary Outcome
Title Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who have received at least 1 dose of study drug. Participants will be analyzed according to the treatment to which they were randomized.The missing equals failure approach was used where all participants with missing data were considered to have failed to achieve the endpoint.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 60 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.7
(64.0 to 86.6)
6.9
(0.8 to 22.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments Fisher's exact test without adjusting for strata at baseline
2.Secondary Outcome
Title Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
Hide Description HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serologically Evaluable FAS For HBeAg loss/seroconversion: participants who were randomized and had received at least 1 dose of study drug, and with HBeAg positive and HBeAb negative or missing at baseline. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 56 29
Measure Type: Number
Unit of Measure: percentage of participants
25.0 24.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.935
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata
3.Secondary Outcome
Title Percentage of Participants With Normal ALT at Week 48
Hide Description Normal alanine amino transferase (ALT) was defined as ≤ 30 U/L for males and females 0−12 years based on the American Association for the Study of Liver Diseases (AASLD) pediatric normal range.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 60 29
Measure Type: Number
Unit of Measure: percentage of participants
51.7 17.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata
4.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 48
Hide Description Normal alanine amino transferase (ALT) was defined as ≤ 30 U/L for males and females 0−12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 60 28
Measure Type: Number
Unit of Measure: percentage of participants
51.7 17.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata
5.Secondary Outcome
Title Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT at Week 48
Hide Description Normal alanine amino transferase (ALT) was defined as ≤ 30 U/L for males and females 0−12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 60 28
Measure Type: Number
Unit of Measure: percentage of participants
46.7 7.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata
6.Secondary Outcome
Title Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 60 29
Measure Type: Number
Unit of Measure: percentage of participants
71.7 6.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata
7.Secondary Outcome
Title Percentage of Participants With HBsAg Loss
Hide Description HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serologically Evaluable Full Analysis Set For HBsAg Loss/Seroconversion; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 60 29
Measure Type: Number
Unit of Measure: percentage of participants
3.3 3.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata
8.Secondary Outcome
Title Percentage of Participants With HBsAg Seroconversion
Hide Description HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serologically Evaluable Full Analysis Set For HBsAg Loss/Seroconversion; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 60 29
Measure Type: Number
Unit of Measure: percentage of participants
0 0
9.Secondary Outcome
Title Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 48 were analyzed.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 10 26
Measure Type: Count of Participants
Unit of Measure: Participants
5
  50.0%
7
  26.9%
10.Secondary Outcome
Title Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144
Hide Description [Not Specified]
Time Frame Baseline; Week 144
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Spine Dual X-Ray Absorptiometry (DXA) Analysis Set: all randomized participants who received at least 1 dose of study drug and had nonmissing baseline spine bone mineral density values.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 60 29
Measure Type: Number
Unit of Measure: percentage of participants
18.3 6.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Comparison of the difference in percentages
Method of Estimation Estimation Parameter Exact Chan-Zhang method
Estimated Value 11.4
Confidence Interval (2-Sided) 95%
-6.9 to 25.1
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density of Spine
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Spine DXA Analysis Set with available data were analyzed.
Arm/Group Title Tenofovir Disoproxil Fumarate Placebo
Hide Arm/Group Description:
Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
Overall Number of Participants Analyzed 55 28
Mean (Standard Deviation)
Unit of Measure: Percent change in spine BMD
3.798  (5.9118) 7.557  (4.9790)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANOVA
Comments two-sided superiority test
Time Frame Double-Blind Phase: Up to the 48 week data cut
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title Tenofovir Disoproxil Fumarate (Blinded Randomized Phase) Placebo (Blinded Randomized Phase)
Hide Arm/Group Description Blinded Randomized Phase: TDF tablet or oral powder once daily (up to 300 mg depending on weight) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) Blinded Randomized Phase: Placebo tablet or oral powder once daily for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3)
All-Cause Mortality
Tenofovir Disoproxil Fumarate (Blinded Randomized Phase) Placebo (Blinded Randomized Phase)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/29 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tenofovir Disoproxil Fumarate (Blinded Randomized Phase) Placebo (Blinded Randomized Phase)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/60 (16.67%)   2/29 (6.90%) 
Infections and infestations     
Acute hepatitis B  1  1/60 (1.67%)  0/29 (0.00%) 
Pneumonia  1  1/60 (1.67%)  0/29 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  4/60 (6.67%)  1/29 (3.45%) 
Hepatic enzyme increased  1  1/60 (1.67%)  0/29 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/60 (0.00%)  1/29 (3.45%) 
Nervous system disorders     
Encephalopathy  1  1/60 (1.67%)  0/29 (0.00%) 
Renal and urinary disorders     
Pelvi-ureteric obstruction  1  1/60 (1.67%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adenoidal hypertrophy  1  1/60 (1.67%)  0/29 (0.00%) 
Hypoxia  1  1/60 (1.67%)  0/29 (0.00%) 
Tonsillar hypertrophy  1  1/60 (1.67%)  0/29 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tenofovir Disoproxil Fumarate (Blinded Randomized Phase) Placebo (Blinded Randomized Phase)
Affected / at Risk (%) Affected / at Risk (%)
Total   38/60 (63.33%)   16/29 (55.17%) 
Gastrointestinal disorders     
Abdominal pain  1  3/60 (5.00%)  1/29 (3.45%) 
Diarrhoea  1  3/60 (5.00%)  1/29 (3.45%) 
Vomiting  1  3/60 (5.00%)  1/29 (3.45%) 
General disorders     
Pyrexia  1  9/60 (15.00%)  2/29 (6.90%) 
Infections and infestations     
Ear infection  1  3/60 (5.00%)  0/29 (0.00%) 
Nasopharyngitis  1  9/60 (15.00%)  2/29 (6.90%) 
Otitis media  1  3/60 (5.00%)  1/29 (3.45%) 
Pharyngitis  1  3/60 (5.00%)  3/29 (10.34%) 
Tonsillitis  1  3/60 (5.00%)  0/29 (0.00%) 
Upper respiratory tract infection  1  8/60 (13.33%)  5/29 (17.24%) 
Varicella  1  3/60 (5.00%)  0/29 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  3/60 (5.00%)  3/29 (10.34%) 
Nervous system disorders     
Headache  1  2/60 (3.33%)  2/29 (6.90%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/60 (8.33%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  0/60 (0.00%)  2/29 (6.90%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
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: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01651403     History of Changes
Other Study ID Numbers: GS-US-174-0144
2012-000586-20 ( EudraCT Number )
First Submitted: July 25, 2012
First Posted: July 27, 2012
Results First Submitted: August 3, 2018
Results First Posted: September 19, 2018
Last Update Posted: September 19, 2018