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Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy

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ClinicalTrials.gov Identifier: NCT00352053
Recruitment Status : Completed
First Posted : July 14, 2006
Results First Posted : August 19, 2010
Last Update Posted : July 14, 2015
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 HIV Infections
Interventions Drug: Tenofovir DF
Drug: Placebo
Enrollment 87

Recruitment Details There were 17 sites in Brazil and 1 site in Panama. First participant was screened on 13 June 2006. The last study visit occurred on 19 December 2013.
Pre-assignment Details 123 participants were screened.
Arm/Group Title Tenofovir DF Placebo
Hide Arm/Group Description Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablets plus a genotype-guided optimized background regimen (OBR; 3 minimum (min.)/5 maximum (max.) antiretroviral agents (ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
Period Title: Double-Blind Phase (Through Week 48)
Started 45 42
Completed 27 29 [1]
Not Completed 18 13
Reason Not Completed
Virologic Failure             14             10
Physician Decision             2             2
Adverse Event             1             0
Withdrawal by Subject             0             1
Intolerance to Antiretroviral Regimen             1             0
[1]
The 10 participants discontinued for virologic failure enrolled early in the open-label extension.
Period Title: First Extension Phase (Weeks 48-144)
Started 24 [1] 36 [1]
Completed 12 19
Not Completed 12 17
Reason Not Completed
Physician Decision             9             13
Lack of Efficacy             1             4
Pregnancy             1             0
Lost to Follow-up             1             0
[1]
3 participants completed the double-blind phase but did not enroll in the 1st extension phase.
Period Title: Second Extension Phase (Weeks 144-240)
Started 9 [1] 14 [2]
Completed 4 9
Not Completed 5 5
Reason Not Completed
Physician Decision             4             4
Withdrawal by Subject             1             1
[1]
3 participants completed the 1st extension phase but did not enroll in the 2nd extension phase.
[2]
5 participants completed the 1st extension phase but did not enroll in the 2nd extension phase.
Period Title: Third Extension Phase (Weeks 240-294)
Started 1 [1] 4 [2]
Completed 0 2
Not Completed 1 2
Reason Not Completed
Lack of Efficacy             1             1
Withdrawal by Subject             0             1
[1]
3 participants completed the 2nd extension phase but did not enroll in the 3rd extension phase.
[2]
5 participants completed the 2nd extension phase but did not enroll in the 3rd extension phase.
Arm/Group Title Tenofovir DF Placebo Total
Hide Arm/Group Description TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. Total of all reporting groups
Overall Number of Baseline Participants 45 42 87
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 42 participants 87 participants
<=18 years
45
 100.0%
42
 100.0%
87
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 42 participants 87 participants
14  (1.5) 14  (1.5) 14  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 42 participants 87 participants
Female
24
  53.3%
25
  59.5%
49
  56.3%
Male
21
  46.7%
17
  40.5%
38
  43.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 42 participants 87 participants
Hispanic or Latino
45
 100.0%
42
 100.0%
87
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 42 participants 87 participants
White 23 22 45
Black or African Heritage 14 11 25
Mulatto 4 4 8
Mixed Race 1 2 3
Indian Descendant 1 1 2
Mestizo 0 2 2
Black and White Race 1 0 1
South American Indian 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 42 participants 87 participants
Panama 2 2 4
Brazil 43 40 83
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 45 participants 42 participants 87 participants
18.72  (2.304) 19.99  (3.238) 19.33  (2.849)
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 45 participants 42 participants 87 participants
390  (244.0) 357  (200.8) 374  (223.5)
CD4 Percentage   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of CD4 lymphocytes
Number Analyzed 45 participants 42 participants 87 participants
17.8  (9.70) 17.6  (8.31) 17.7  (9.00)
[1]
Measure Description: CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 45 participants 42 participants 87 participants
155.84  (10.071) 156.05  (8.569) 155.94  (9.322)
Human Immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA)  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 45 participants 42 participants 87 participants
4.71  (0.723) 4.56  (0.746) 4.64  (0.734)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 45 participants 42 participants 87 participants
45.84  (9.639) 49.09  (11.342) 47.41  (10.561)
1.Primary Outcome
Title Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA
Hide Description

DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.

Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed).

Time Frame Baseline to 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least 1 dose of study drug, with baseline HIV-1 RNA ≥ 1000 copies/mL and who had no major eligibility criteria violations.
Arm/Group Title Tenofovir DF Placebo
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Overall Number of Participants Analyzed 44 41
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-1.580
(-2.15 to -0.27)
-1.549
(-2.36 to -0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments No adjustments for multiple comparisons were made.
Method Van Elteren test
Comments P-value is from a Van Elteren test stratified by baseline genotypic sensitivity score (GSS) (without tenofovir DF) <= or > median (median GSS is 2).
2.Secondary Outcome
Title Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA
Hide Description

DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.

Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed).

Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tenofovir DF Placebo
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Overall Number of Participants Analyzed 44 41
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-1.423
(-2.25 to -0.25)
-1.352
(-2.72 to -0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments No adjustments for multiple comparisons were made.
Method Van Elteren test
Comments P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).
3.Secondary Outcome
Title Change From Baseline to Week 24 in HIV-1 RNA
Hide Description [Not Specified]
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the last observation carried forward (LOCF) method (includes the participant’s last available postbaseline value for missing data). The Placebo/TDF groups were analyzed using the missing = excluded method (participants with missing data were excluded from the analysis).
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 44 41 18 16
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-1.23
(-2.3 to -0.1)
-1.27
(-2.8 to -0.1)
0.0
(0.0 to 0.0)
-0.1
(-0.6 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments No adjustments for multiple comparisons were made.
Method Van Elteren test
Comments P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).
4.Secondary Outcome
Title Change From Baseline to Week 48 in HIV-1 RNA
Hide Description [Not Specified]
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 44 41 18 8
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-0.97
(-2.3 to 0.0)
-1.53
(-3.0 to 0.0)
0.0
(0.0 to 0.6)
0.2
(-0.1 to 0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments No adjustments for multiple comparisons were made.
Method Van Elteren test
Comments P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).
5.Secondary Outcome
Title Change From Baseline to Week 96 in HIV-1 RNA
Hide Description [Not Specified]
Time Frame Baseline to 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 19 17 3
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-2.1
(-2.5 to -0.6)
0.0
(0.0 to 0.9)
0.1
(-1.4 to 0.8)
6.Secondary Outcome
Title Change From Baseline to Week 144 in HIV-1 RNA
Hide Description [Not Specified]
Time Frame Baseline to 144 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 10 11 2
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-2.5
(-2.7 to -2.2)
0.2
(0.0 to 1.6)
0.7
(0.6 to 0.8)
7.Secondary Outcome
Title Change From Baseline to Week 192 in HIV-1 RNA
Hide Description [Not Specified]
Time Frame Baseline to 192 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 7 5 2
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-2.0
(-2.5 to -0.7)
0.0
(0.0 to 0.2)
-0.1
(-1.4 to 1.3)
8.Secondary Outcome
Title Change From Baseline to Week 240 in HIV-1 RNA
Hide Description [Not Specified]
Time Frame Baseline to 240 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 4 2 1
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-2.5
(-2.6 to -2.2)
-0.4
(-0.8 to 0.0)
-1.4
(-1.4 to -1.4)
9.Secondary Outcome
Title Change From Baseline to Week 288 in HIV-1 RNA
Hide Description [Not Specified]
Time Frame Baseline to 288 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 1 1 1
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
-1.1
(-1.1 to -1.1)
-0.8
(-0.8 to -0.8)
0.6
(0.6 to 0.6)
10.Secondary Outcome
Title Change From Baseline to Week 336 in HIV-1 RNA
Hide Description No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Time Frame Baseline to 336 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count
Hide Description [Not Specified]
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 42 41 18 16
Median (Inter-Quartile Range)
Unit of Measure: cells/mm3
69
(-26 to 172)
49
(-3 to 156)
-43
(-181 to 53)
-12
(-48 to 59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Changes from baseline through Week 24 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments No adjustments for multiple comparisons were made.
Method Van Elteren test
Comments P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).
12.Secondary Outcome
Title Change From Baseline to Week 48 in CD4 Count
Hide Description [Not Specified]
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 32 31 17 11
Median (Inter-Quartile Range)
Unit of Measure: cells/mm3
152
(-4 to 241)
148
(42 to 289)
15
(-69 to 95)
-47
(-83 to 67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Changes from baseline through Week 48 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments No adjustments for multiple comparisons were made.
Method Van Elteren test
Comments P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).
13.Secondary Outcome
Title Change From Baseline to Week 96 in CD4 Count
Hide Description [Not Specified]
Time Frame Baseline to 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 20 17 3
Median (Inter-Quartile Range)
Unit of Measure: cells/mm3
152
(52 to 266)
-6
(-96 to 85)
-69
(-75 to 278)
14.Secondary Outcome
Title Change From Baseline to Week 144 in CD4 Count
Hide Description [Not Specified]
Time Frame Baseline to 144 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 12 11 2
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
188
(53 to 361)
-88
(-165 to 93)
33
(-109 to 174)
15.Secondary Outcome
Title Change From Baseline to Week 192 in CD4 Count
Hide Description [Not Specified]
Time Frame Baseline to 192 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 7 6 2
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
166
(-82 to 333)
-70
(-155 to 220)
-23
(-46 to 1)
16.Secondary Outcome
Title Change From Baseline to Week 240 in CD4 Count
Hide Description [Not Specified]
Time Frame Baseline to 240 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 5 2 1
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
221
(59 to 368)
571
(-13 to 1155)
258
(258 to 258)
17.Secondary Outcome
Title Change From Baseline to Week 288 in CD4 Count
Hide Description [Not Specified]
Time Frame Baseline to 288 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 1 1 1
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
310
(310 to 310)
100
(100 to 100)
309
(309 to 309)
18.Secondary Outcome
Title Change From Baseline to Week 336 in CD4 Count
Hide Description No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Time Frame Baseline to 336 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Change From Baseline to Week 24 in CD4 Percentage
Hide Description CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 42 41 18 16
Median (Inter-Quartile Range)
Unit of Measure: Percentage of CD4 lymphocytes
3.0
(0.0 to 6.0)
2.0
(-1.0 to 4.0)
0.0
(-3.0 to 3.0)
-1.0
(-3.0 to 2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Changes from baseline through Week 24 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4% for the tenofovir DF and placebo groups are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments No adjustments for multiple comparisons were made.
Method Van Elteren test
Comments P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).
20.Secondary Outcome
Title Change From Baseline to Week 48 in CD4 Percentage
Hide Description CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 32 31 17 11
Median (Inter-Quartile Range)
Unit of Measure: Percentage of CD4 lymphocytes
6.0
(2.5 to 9.0)
5.0
(2.0 to 8.0)
2.0
(1.0 to 4.0)
-1.0
(-4.0 to 7.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Changes from baseline through Week 48 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4% for the tenofovir DF and placebo groups are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments No adjustments for multiple comparisons were made.
Method Van Elteren test
Comments P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).
21.Secondary Outcome
Title Change From Baseline to Week 96 in CD4 Percentage
Hide Description CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Time Frame Baseline to 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 20 17 3
Median (Inter-Quartile Range)
Unit of Measure: Percentage of CD4 lymphocytes
5.0
(2.0 to 8.0)
2.0
(0.0 to 5.0)
9.0
(2.0 to 15.0)
22.Secondary Outcome
Title Change From Baseline to Week 144 in CD4 Percentage
Hide Description CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Time Frame Baseline to 144 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 12 11 2
Median (Inter-Quartile Range)
Unit of Measure: Percentage of CD4 lymphocytes
6.5
(-2.0 to 13.0)
0.0
(-4.0 to 8.0)
5.5
(2.0 to 9.0)
23.Secondary Outcome
Title Change From Baseline to Week 192 in CD4 Percentage
Hide Description CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Time Frame Baseline to 192 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 7 6 2
Median (Inter-Quartile Range)
Unit of Measure: Percentage of CD4 lymphocytes
5.0
(-2.0 to 11.6)
1.9
(-1.0 to 10.0)
4.8
(1.5 to 8.0)
24.Secondary Outcome
Title Change From Baseline to Week 240 in CD4 Percentage
Hide Description CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Time Frame Baseline to 240 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 5 2 1
Median (Inter-Quartile Range)
Unit of Measure: Percentage of CD4 lymphocytes
10.0
(-2.0 to 13.3)
8.9
(8.2 to 9.6)
18.9
(18.9 to 18.9)
25.Secondary Outcome
Title Change From Baseline to Week 288 in CD4 Percentage
Hide Description CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Time Frame Baseline to 288 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 1 1 1
Median (Inter-Quartile Range)
Unit of Measure: Percentage of CD4 lymphocytes
7.4
(7.4 to 7.4)
4.0
(4.0 to 4.0)
11.9
(11.9 to 11.9)
26.Secondary Outcome
Title Change From Baseline to Week 336 in CD4 Percentage
Hide Description No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Time Frame Baseline to 336 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24
Hide Description [Not Specified]
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 44 41 18 16
Measure Type: Number
Unit of Measure: Percentage of participants
56.8 51.2 0 12.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments No adjustments for multiple comparisons were made.
Method Fisher Exact
Comments No adjustments were made.
28.Secondary Outcome
Title Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48
Hide Description [Not Specified]
Time Frame Baseline to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 44 41 18 8
Measure Type: Number
Unit of Measure: Percentage of participants
47.7 53.7 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments No adjustments for multiple comparisons were made.
Method Fisher Exact
Comments No adjustments were made.
29.Secondary Outcome
Title Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96
Hide Description [Not Specified]
Time Frame Baseline to 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 19 17 3
Measure Type: Number
Unit of Measure: Percentage of participants
73.7 5.9 33.3
30.Secondary Outcome
Title Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144
Hide Description [Not Specified]
Time Frame Baseline to 144 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 10 11 2
Measure Type: Number
Unit of Measure: Percentage of participants
90.0 0 0
31.Secondary Outcome
Title Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192
Hide Description [Not Specified]
Time Frame Baseline to 192 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 7 5 2
Measure Type: Number
Unit of Measure: Percentage of participants
71.4 0 50.0
32.Secondary Outcome
Title Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240
Hide Description [Not Specified]
Time Frame Baseline to 240 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 4 2 1
Measure Type: Number
Unit of Measure: Percentage of participants
100.0 0 100.0
33.Secondary Outcome
Title Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288
Hide Description [Not Specified]
Time Frame Baseline to 288 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: Percentage of participants
100.0 0 0
34.Secondary Outcome
Title Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336
Hide Description No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Time Frame Baseline to 336 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
35.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint. The Placebo/TDF groups were analyzed using the missing = excluded method.
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 44 41 18 16
Measure Type: Number
Unit of Measure: Percentage of participants
40.9 41.5 83.3 6.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments No adjustments for multiple comparisons were made.
Method Fisher Exact
Comments No adjustments were made.
36.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 44 41 18 8
Measure Type: Number
Unit of Measure: Percentage of participants
34.1 43.9 77.8 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments No adjustments for multiple comparisons were made.
Method Fisher Exact
Comments No adjustments were made.
37.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 19 17 3
Measure Type: Number
Unit of Measure: Percentage of participants
63.2 70.6 33.3
38.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
Hide Description [Not Specified]
Time Frame Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 10 11 2
Measure Type: Number
Unit of Measure: Percentage of participants
70.0 72.7 0
39.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192
Hide Description [Not Specified]
Time Frame Week 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 7 5 2
Measure Type: Number
Unit of Measure: Percentage of participants
57.1 80.0 50.0
40.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240
Hide Description [Not Specified]
Time Frame Week 240
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 4 2 1
Measure Type: Number
Unit of Measure: Percentage of participants
75.0 100.0 100.0
41.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288
Hide Description [Not Specified]
Time Frame Week 288
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: Percentage of participants
0 100.0 0
42.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336
Hide Description No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Time Frame Week 336
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
43.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 44 41 18 16
Measure Type: Number
Unit of Measure: Percentage of participants
20.5 34.1 77.8 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments No adjustments for multiple comparisons were made.
Method Fisher Exact
Comments No adjustments were made.
44.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.
Arm/Group Title Tenofovir DF Placebo Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 44 41 18 8
Measure Type: Number
Unit of Measure: Percentage of participants
27.3 36.6 61.1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments No adjustments for multiple comparisons were made.
Method Fisher Exact
Comments No adjustments were made.
45.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 19 17 3
Measure Type: Number
Unit of Measure: Percentage of participants
47.4 58.8 33.3
46.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
Hide Description [Not Specified]
Time Frame Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 10 11 2
Measure Type: Number
Unit of Measure: Percentage of participants
70.0 45.5 0
47.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
Hide Description [Not Specified]
Time Frame Week 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 7 5 2
Measure Type: Number
Unit of Measure: Percentage of participants
42.9 60.0 50.0
48.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240
Hide Description [Not Specified]
Time Frame Week 240
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 4 2 1
Measure Type: Number
Unit of Measure: Percentage of participants
75.0 100.0 100.0
49.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288
Hide Description [Not Specified]
Time Frame Week 288
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: Percentage of participants
0 100.0 0
50.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336
Hide Description No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Time Frame Week 336
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set, missing = excluded method
Arm/Group Title Tenofovir DF Placebo/TDF, HIV-1 RNA < 1000 Copies/mL Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
51.Secondary Outcome
Title Percentage of Participants With Virologic Failure Through Week 48
Hide Description

Virologic failure was defined as either nonresponse or viral rebound.

  • Nonresponse (failure to achieve response). Response was defined as either

    • A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or
    • HIV-1 RNA < 400 copies/mL at 2 consecutive visits.
  • Viral rebound was defined as either

    • Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or
    • Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.

The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase.

Time Frame Up to 48 weeks
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Hide Analysis Population Description
ITT Analysis Set. 1 participant without time to respond [6 days of treatment]) was excluded. Nonresponders were counted as failures at time 0. Rebounders were counted as failures on study day of the first of 2 assessments meeting criteria. Otherwise, they were censored at last double-blind HIV measurement.
Arm/Group Title Tenofovir DF Placebo
Hide Arm/Group Description:
TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
Overall Number of Participants Analyzed 43 41
Measure Type: Number
Unit of Measure: Kaplan-Meier percentage
51 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Placebo
Comments Null hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are equal. Alternative hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are different (two-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments No adjustments for multiple comparisons were made.
Method Log Rank
Comments No adjustments were made.
Time Frame Up to Week 294 plus 30 days.
Adverse Event Reporting Description Safety Analysis Set: participants were randomized and received at least 1 dose of study medication. MedDRA version 11.1 was used for the Tenofovir DF and Placebo columns; MedDRA version 16.1 was used for the All TDF column.
 
Arm/Group Title Tenofovir DF Placebo All TDF
Hide Arm/Group Description

Adverse events occurring in the double-blind phase are presented for this reporting group.

TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.

Adverse events occurring in the double-blind phase are presented for this reporting group.

Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.

Adverse events reported for the All TDF group include those reported during the double-blind phase and/or extension phase for subjects who were randomized to TDF group plus adverse events reported during the extension phase only for subjects who switched from placebo to open-label TDF.

Tenofovir DF 300-mg tablets in participants initially randomized to the Tenofovir DF group, and in those initially randomized to the Placebo group who later switched to open-label TDF 300 mg.

All-Cause Mortality
Tenofovir DF Placebo All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tenofovir DF Placebo All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/45 (22.22%)   3/42 (7.14%)   20/81 (24.69%) 
Blood and lymphatic system disorders       
Neutropenia  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Infections and infestations       
Pneumonia  1  3/45 (6.67%)  1/42 (2.38%)  5/81 (6.17%) 
Sinusitis  1  2/45 (4.44%)  0/42 (0.00%)  2/81 (2.47%) 
Herpes Zoster  1  0/45 (0.00%)  0/42 (0.00%)  3/81 (3.70%) 
Cryptococcosis  1  1/45 (2.22%)  0/42 (0.00%)  1/81 (1.23%) 
Gastroenteritis  1  1/45 (2.22%)  0/42 (0.00%)  1/81 (1.23%) 
Pneumocystis Jiroveci Pneumonia  1  2/45 (4.44%)  0/42 (0.00%)  2/81 (2.47%) 
Respiratory Tract Infection  1  1/45 (2.22%)  0/42 (0.00%)  1/81 (1.23%) 
Urinary Tract Infection  1  1/45 (2.22%)  0/42 (0.00%)  1/81 (1.23%) 
Abscess  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Abscess Limb  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Cellulitis  1  0/45 (0.00%)  1/42 (2.38%)  0/81 (0.00%) 
Cerebral Toxoplasmosis  1  0/45 (0.00%)  1/42 (2.38%)  0/81 (0.00%) 
Mastoiditis  1  0/45 (0.00%)  1/42 (2.38%)  0/81 (0.00%) 
Neurocryptococcosis  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Pyelonephritis  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Injury, poisoning and procedural complications       
Overdose  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital Warts  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Nervous system disorders       
Convulsion  1  1/45 (2.22%)  0/42 (0.00%)  1/81 (1.23%) 
Psychiatric disorders       
Psychotic Disorder  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Suicide Attempt  1  0/45 (0.00%)  0/42 (0.00%)  1/81 (1.23%) 
Renal and urinary disorders       
Proteinuria  1  1/45 (2.22%)  0/42 (0.00%)  1/81 (1.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tenofovir DF Placebo All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/45 (97.78%)   35/42 (83.33%)   76/81 (93.83%) 
Blood and lymphatic system disorders       
Neutropenia  1  4/45 (8.89%)  1/42 (2.38%)  7/81 (8.64%) 
Eye disorders       
Conjunctivitis  1  2/45 (4.44%)  1/42 (2.38%)  5/81 (6.17%) 
Gastrointestinal disorders       
Vomiting  1  16/45 (35.56%)  5/42 (11.90%)  21/81 (25.93%) 
Diarrhoea  1  10/45 (22.22%)  4/42 (9.52%)  17/81 (20.99%) 
Nausea  1  11/45 (24.44%)  3/42 (7.14%)  15/81 (18.52%) 
Abdominal Pain  1  8/45 (17.78%)  5/42 (11.90%)  9/81 (11.11%) 
Gastritis  1  5/45 (11.11%)  1/42 (2.38%)  7/81 (8.64%) 
Constipation  1  3/45 (6.67%)  0/42 (0.00%)  4/81 (4.94%) 
General disorders       
Pyrexia  1  4/45 (8.89%)  5/42 (11.90%)  7/81 (8.64%) 
Hepatobiliary disorders       
Jaundice  1  3/45 (6.67%)  3/42 (7.14%)  4/81 (4.94%) 
Infections and infestations       
Sinusitis  1  12/45 (26.67%)  6/42 (14.29%)  24/81 (29.63%) 
Nasopharyngitis  1  8/45 (17.78%)  7/42 (16.67%)  18/81 (22.22%) 
Upper Respiratory Tract Infection  1  8/45 (17.78%)  3/42 (7.14%)  17/81 (20.99%) 
Tonsillitis  1  4/45 (8.89%)  3/42 (7.14%)  12/81 (14.81%) 
Oral Herpes  1  5/45 (11.11%)  3/42 (7.14%)  9/81 (11.11%) 
Tracheobronchitis  1  5/45 (11.11%)  1/42 (2.38%)  9/81 (11.11%) 
Acute Sinusitis  1  3/45 (6.67%)  4/42 (9.52%)  6/81 (7.41%) 
Rhinitis  1  3/45 (6.67%)  1/42 (2.38%)  7/81 (8.64%) 
Pneumonia  1  2/45 (4.44%)  2/42 (4.76%)  5/81 (6.17%) 
Body Tinea  1  2/45 (4.44%)  1/42 (2.38%)  5/81 (6.17%) 
Furuncle  1  3/45 (6.67%)  1/42 (2.38%)  4/81 (4.94%) 
Gastroenteritis  1  2/45 (4.44%)  1/42 (2.38%)  5/81 (6.17%) 
Bronchopneumonia  1  2/45 (4.44%)  0/42 (0.00%)  5/81 (6.17%) 
Hordeolum  1  3/45 (6.67%)  1/42 (2.38%)  3/81 (3.70%) 
Impetigo  1  1/45 (2.22%)  3/42 (7.14%)  3/81 (3.70%) 
Herpes Zoster  1  0/45 (0.00%)  3/42 (7.14%)  3/81 (3.70%) 
Metabolism and nutrition disorders       
Hypertriglyceridaemia  1  3/45 (6.67%)  3/42 (7.14%)  6/81 (7.41%) 
Anorexia  1  4/45 (8.89%)  1/42 (2.38%)  0/81 (0.00%) 
Decreased Appetite  1  0/45 (0.00%)  0/42 (0.00%)  5/81 (6.17%) 
Musculoskeletal and connective tissue disorders       
Osteopenia  1  3/45 (6.67%)  2/42 (4.76%)  5/81 (6.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin Papilloma  1  0/45 (0.00%)  3/42 (7.14%)  2/81 (2.47%) 
Nervous system disorders       
Headache  1  6/45 (13.33%)  5/42 (11.90%)  16/81 (19.75%) 
Dizziness  1  8/45 (17.78%)  5/42 (11.90%)  11/81 (13.58%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  11/45 (24.44%)  6/42 (14.29%)  24/81 (29.63%) 
Bronchospasm  1  3/45 (6.67%)  2/42 (4.76%)  5/81 (6.17%) 
Skin and subcutaneous tissue disorders       
Acne  1  1/45 (2.22%)  0/42 (0.00%)  7/81 (8.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Participants left the study for a number of reasons (eg, turned 18 years old, switched to a different HIV treatment regimen), which led to small numbers of participants analyzed at later time points, and the study was concluded earlier than planned.
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: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00352053     History of Changes
Other Study ID Numbers: GS-US-104-0321
First Submitted: July 13, 2006
First Posted: July 14, 2006
Results First Submitted: March 5, 2010
Results First Posted: August 19, 2010
Last Update Posted: July 14, 2015