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Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00528957
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : March 22, 2012
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Tenofovir DF
Drug: Zidovudine
Drug: Stavudine
Enrollment 97
Recruitment Details Participants were enrolled at study sites in the United States, Panama, and the United Kingdom. The first participant was screened on 28 December 2006. The last study visit occurred on 16 August 2017.
Pre-assignment Details 127 participants were screened.
Arm/Group Title Tenofovir DF Stavudine or Zidovudine
Hide Arm/Group Description Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
Period Title: Randomized Phase (Baseline to Week 48)
Started 48 49
Completed 44 48
Not Completed 4 1
Reason Not Completed
Withdrew Consent             2             1
Safety, Tolerability, or Efficacy Reason             2             0
Period Title: First Extension (Week 48 to Week 144)
Started 38 [1] 41 [2]
Completed 35 40
Not Completed 3 1
Reason Not Completed
Investigator's Discretion             2             0
Safety, Tolerability, or Efficacy Reason             1             0
Withdrew Consent             0             1
[1]
Six participants completed the 48-week randomized phase and did not enroll in the first extension.
[2]
Seven participants completed the 48-week randomized phase and did not enroll in the first extension.
Period Title: Second Extension (Week 144 to Week 240)
Started 34 [1] 40
Completed 27 37
Not Completed 7 3
Reason Not Completed
Safety, Tolerability, or Efficacy Reason             4             3
Investigator's Discretion             3             0
[1]
One participant completed the first extension and did not enroll in the second extension.
Period Title: Third Extension (Week 240 to Week 336)
Started 27 37
Completed 21 27
Not Completed 6 10
Reason Not Completed
Safety, Tolerability, or Efficacy Reason             5             4
Lost to Follow-up             0             3
= 18 yr old & TDF approved in adults             1             1
Investigator's Discretion             0             1
Withdrew Consent             0             1
Period Title: Long-Term Extension (Week 336 and On)
Started 19 [1] 25 [1]
Completed 9 8
Not Completed 10 17
Reason Not Completed
Rolled Over to Study GS-US-311-1269             4             10
Safety, Tolerability, or Efficacy Reason             3             5
Withdrew Consent             2             1
Investigator's Discretion             1             1
[1]
Two participants completed the third extension and did not enroll in the long-term extension.
Arm/Group Title Tenofovir DF Stavudine or Zidovudine Total
Hide Arm/Group Description Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). Total of all reporting groups
Overall Number of Baseline Participants 48 49 97
Hide Baseline Analysis Population Description
Randomized and Treated Set: participants who were randomized and received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 49 participants 97 participants
7  (3.3) 7  (2.6) 7  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 97 participants
Female
27
  56.3%
20
  40.8%
47
  48.5%
Male
21
  43.8%
29
  59.2%
50
  51.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 97 participants
Hispanic or Latino
35
  72.9%
42
  85.7%
77
  79.4%
Not Hispanic or Latino
13
  27.1%
7
  14.3%
20
  20.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 97 participants
American Indian or Alaska Native
2
   4.2%
0
   0.0%
2
   2.1%
Asian
1
   2.1%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  27.1%
6
  12.2%
19
  19.6%
White
3
   6.3%
6
  12.2%
9
   9.3%
Mestizo
28
  58.3%
37
  75.5%
65
  67.0%
Native Indian (Kuna)
1
   2.1%
0
   0.0%
1
   1.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 48 participants 49 participants 97 participants
United States
13
  27.1%
9
  18.4%
22
  22.7%
Panama
33
  68.8%
39
  79.6%
72
  74.2%
United Kingdom
2
   4.2%
1
   2.0%
3
   3.1%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 48 participants 49 participants 97 participants
118  (19.8) 119  (16.7) 119  (18.2)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 48 participants 49 participants 97 participants
17.59  (3.680) 16.59  (1.762) 17.08  (2.905)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 48 participants 49 participants 97 participants
25.9  (12.03) 24.1  (7.77) 25.0  (10.09)
Plasma HIV-1 RNA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 97 participants
< 50 copies/mL
36
  75.0%
41
  83.7%
77
  79.4%
50 to < 400 copies/mL
11
  22.9%
6
  12.2%
17
  17.5%
400 to < 1000 copies/mL
1
   2.1%
1
   2.0%
2
   2.1%
≥ 1000 copies/mL
0
   0.0%
1
   2.0%
1
   1.0%
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 48 participants 49 participants 97 participants
1190  (541.7) 1144  (388.4) 1167  (468.6)
CD4 Percentage  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 48 participants 49 participants 97 participants
33.9  (7.44) 33.0  (6.82) 33.5  (7.11)
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure
Arm/Group Title Tenofovir DF Stavudine or Zidovudine All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 48 49 89
Measure Type: Number
Unit of Measure: percentage of participants
83.3 91.8 85.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Stavudine or Zidovudine
Comments

The statistical hypotheses for the primary endpoint was as follows:

  • Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations < 400 copies/mL at Week 48.
  • Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.
Type of Statistical Test Non-Inferiority or Equivalence
Comments In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA < 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal approximation
Comments The difference between the two proportions and its CI were based on normal approximation methods.
Method of Estimation Estimation Parameter Difference in percentages between groups
Estimated Value -8.5
Confidence Interval (2-Sided) 95%
-21.5 to 4.5
Estimation Comments Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase)
2.Secondary Outcome
Title Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)
Hide Description This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Analysis Set; only includes participants < 12 years of age at baseline
Arm/Group Title Tenofovir DF Stavudine or Zidovudine
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
Overall Number of Participants Analyzed 44 48
Measure Type: Number
Unit of Measure: percentage of participants
88.6 89.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir DF, Stavudine or Zidovudine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA < 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.
Method of Estimation Estimation Parameter Difference in percentages between groups
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-13.7 to 11.8
Estimation Comments The difference between the two proportions and its CI were based on normal approximation methods.
3.Secondary Outcome
Title Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)
Hide Description This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Analysis Set; only includes participants < 12 years of age at baseline
Arm/Group Title Tenofovir DF Stavudine or Zidovudine
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
Overall Number of Participants Analyzed 44 48
Measure Type: Number
Unit of Measure: percentage of participants
75.0 81.3
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.
Time Frame 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 38 41 79
Measure Type: Number
Unit of Measure: percentage of participants
81.6 85.4 83.5
5.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.
Time Frame 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received tenofovir DF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 38 40 78
Measure Type: Number
Unit of Measure: percentage of participants
73.7 87.5 80.8
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF.
Time Frame 192 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received TDF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 34 40 74
Measure Type: Number
Unit of Measure: percentage of participants
70.6 82.5 77.0
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF.
Time Frame 240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received TDF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 34 37 71
Measure Type: Number
Unit of Measure: percentage of participants
70.6 75.7 73.2
8.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF.
Time Frame 288 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received TDF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 27 37 64
Measure Type: Number
Unit of Measure: percentage of participants
81.5 67.6 73.4
9.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF.
Time Frame 336 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received TDF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 22 21 43
Measure Type: Number
Unit of Measure: percentage of participants
90.9 100.0 95.3
10.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF.
Time Frame 384 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received TDF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 17 9 26
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0
11.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF.
Time Frame 432 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received TDF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 13 7 20
Measure Type: Number
Unit of Measure: percentage of participants
100.0 85.7 95.0
12.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF.
Time Frame 480 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received TDF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 9 2 11
Measure Type: Number
Unit of Measure: percentage of participants
88.9 100.0 90.9
13.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF.
Time Frame 528 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
All participants who received TDF in the randomized and/or extension phases (All TDF group)
Overall Number of Participants Analyzed 6 0 6
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0
14.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF Stavudine or Zidovudine All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks)
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 48 49 89
Measure Type: Number
Unit of Measure: percentage of participants
70.8 85.7 68.5
15.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.
Time Frame 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 38 41 79
Measure Type: Number
Unit of Measure: percentage of participants
76.3 68.3 72.2
16.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.
Time Frame 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 38 40 78
Measure Type: Number
Unit of Measure: percentage of participants
63.2 75.0 69.2
17.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF.
Time Frame 192 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 34 40 74
Measure Type: Number
Unit of Measure: percentage of participants
67.6 75.0 71.6
18.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF.
Time Frame 240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 34 37 71
Measure Type: Number
Unit of Measure: percentage of participants
70.6 73.0 71.8
19.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF.
Time Frame 288 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 27 37 64
Measure Type: Number
Unit of Measure: percentage of participants
81.5 62.2 70.3
20.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF.
Time Frame 336 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 22 21 43
Measure Type: Number
Unit of Measure: percentage of participants
86.4 90.5 88.4
21.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF.
Time Frame 384 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 17 9 26
Measure Type: Number
Unit of Measure: percentage of participants
88.2 100.0 92.3
22.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF.
Time Frame 432 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 13 7 20
Measure Type: Number
Unit of Measure: percentage of participants
100.0 71.4 90.0
23.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF.
Time Frame 480 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 9 2 11
Measure Type: Number
Unit of Measure: percentage of participants
77.8 50.0 72.7
24.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
Hide Description This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF.
Time Frame 528 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 6 0 6
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0
25.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 48 Weeks
Hide Description This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.
Time Frame Baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF Stavudine or Zidovudine All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 46 48 86
Mean (Standard Deviation)
Unit of Measure: percentage
0.3  (4.49) 1.1  (4.73) 0.6  (3.85)
26.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 96 Weeks
Hide Description This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.
Time Frame Baseline and 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 37 38 75
Mean (Standard Deviation)
Unit of Measure: percentage
1.3  (4.08) -0.1  (3.60) 0.6  (3.88)
27.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 144 Weeks
Hide Description This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.
Time Frame Baseline and 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 33 38 71
Mean (Standard Deviation)
Unit of Measure: percentage
0.8  (5.61) -0.1  (3.83) 0.3  (4.73)
28.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 192 Weeks
Hide Description This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.
Time Frame Baseline and 192 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 29 37 66
Mean (Standard Deviation)
Unit of Measure: percentage
1.1  (5.57) 0.6  (3.69) 0.8  (4.58)
29.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 240 Weeks
Hide Description This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.
Time Frame Baseline and 240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 28 32 60
Mean (Standard Deviation)
Unit of Measure: percentage
1.3  (5.98) -0.9  (4.13) 0.1  (5.16)
30.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 288 Weeks
Hide Description This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.
Time Frame Baseline and 288 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 26 26 52
Mean (Standard Deviation)
Unit of Measure: percentage
2.0  (6.30) 0.5  (4.77) 1.3  (5.58)
31.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 336 Weeks
Hide Description This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.
Time Frame Baseline and 336 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 23 22 45
Mean (Standard Deviation)
Unit of Measure: percentage
2.0  (7.19) 0.8  (4.01) 1.4  (5.82)
32.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 384 Weeks
Hide Description This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.
Time Frame Baseline and 384 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 19 10 29
Mean (Standard Deviation)
Unit of Measure: percentage
0.5  (7.80) 1.6  (1.90) 0.9  (6.37)
33.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 432 Weeks
Hide Description This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.
Time Frame Baseline and 432 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 14 7 21
Mean (Standard Deviation)
Unit of Measure: percentage
0.3  (6.41) 2.9  (3.53) 1.1  (5.66)
34.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 480 Weeks
Hide Description This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.
Time Frame Baseline and 480 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 10 3 13
Mean (Standard Deviation)
Unit of Measure: percentage
2.3  (7.15) 5.0  (10.00) 2.9  (7.51)
35.Secondary Outcome
Title Change From Baseline in CD4 Percentage at 528 Weeks
Hide Description This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.
Time Frame Baseline and 528 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 6 0 6
Mean (Standard Deviation)
Unit of Measure: percentage
4.5  (3.89) 4.5  (3.89)
36.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks
Hide Description This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.
Time Frame Baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF Stavudine or Zidovudine All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 46 48 86
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-97  (416.4) -11  (280.2) 2  (385.9)
37.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks
Hide Description This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.
Time Frame Baseline and 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 37 37 74
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-77  (408.3) -56  (305.6) -67  (358.3)
38.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks
Hide Description This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.
Time Frame Baseline and 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 33 38 71
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-139  (438.2) -146  (245.3) -142  (345.9)
39.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks
Hide Description This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.
Time Frame Baseline and 192 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 29 37 66
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-304  (529.0) -177  (288.5) -233  (413.2)
40.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks
Hide Description This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.
Time Frame Baseline and 240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 27 32 59
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-369  (529.9) -296  (252.6) -329  (401.7)
41.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks
Hide Description This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.
Time Frame Baseline and 288 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 26 25 51
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-346  (507.5) -256  (292.5) -302  (414.6)
42.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks
Hide Description This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.
Time Frame Baseline and 336 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 23 22 45
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-415  (569.4) -283  (252.2) -350  (443.8)
43.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks
Hide Description This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.
Time Frame Baseline and 384 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 19 10 29
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-620  (635.6) -305  (238.2) -512  (548.8)
44.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks
Hide Description This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.
Time Frame Baseline and 432 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 14 7 21
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-795  (559.2) -302  (355.2) -631  (545.7)
45.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks
Hide Description This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.
Time Frame Baseline and 480 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 10 3 13
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-923  (755.4) -448  (469.9) -813  (712.9)
46.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks
Hide Description This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.
Time Frame Baseline and 528 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, Missing = Excluded
Arm/Group Title Tenofovir DF (Stavudine or Zidovudine)/TDF All TDF
Hide Arm/Group Description:
Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
All participants who received tenofovir DF in the randomized and/or extension phases
Overall Number of Participants Analyzed 6 0 6
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
-710  (447.0) -710  (447.0)
Time Frame Adverse events (AEs) were reported in the open-label randomized period (Weeks 0-48), and during the extension period when all participants received tenofovir DF.
Adverse Event Reporting Description

Tenofovir DF and Stavudine or Zidovudine groups: AEs were reported from baseline through last dose (up to Week 48) + 30 days. AEs with onset during the extension period were excluded.

All TDF group: AEs were reported from baseline through last dose + 30 days (median duration of exposure = 330.7 weeks)
 
Arm/Group Title Tenofovir DF Stavudine or Zidovudine All TDF
Hide Arm/Group Description Participants in this group received TDF during the randomized phase (48 weeks) Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) All participants who received tenofovir DF in the randomized and/or extension phases
All-Cause Mortality
Tenofovir DF Stavudine or Zidovudine All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/49 (0.00%)   0/89 (0.00%) 
Hide Serious Adverse Events
Tenofovir DF Stavudine or Zidovudine All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/48 (4.17%)   2/49 (4.08%)   15/89 (16.85%) 
Blood and lymphatic system disorders       
Lymphadenitis † 1  0/48 (0.00%)  1/49 (2.04%)  0/89 (0.00%) 
Gastrointestinal disorders       
Abdominal adhesions † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Diarrhoea † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Infections and infestations       
Amoebiasis † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Appendicitis † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Cellulitis † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Ear infection † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Gastroenteritis † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Lymph node abscess † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Pharyngotonsillitis † 1  1/48 (2.08%)  0/49 (0.00%)  1/89 (1.12%) 
Pneumonia † 1  1/48 (2.08%)  0/49 (0.00%)  2/89 (2.25%) 
Shigella infection † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Viral infection † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Injury, poisoning and procedural complications       
Joint dislocation † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Snake bite † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Metabolism and nutrition disorders       
Dehydration † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Musculoskeletal and connective tissue disorders       
Haemarthrosis † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Brain neoplasm † 1  0/48 (0.00%)  0/49 (0.00%)  1/89 (1.12%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous † 1  0/48 (0.00%)  0/49 (0.00%)  2/89 (2.25%) 
Respiratory, thoracic and mediastinal disorders       
Asthmatic crisis † 1  0/48 (0.00%)  1/49 (2.04%)  0/89 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tenofovir DF Stavudine or Zidovudine All TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/48 (77.08%)   35/49 (71.43%)   82/89 (92.13%) 
Blood and lymphatic system disorders       
Anaemia † 1  0/48 (0.00%)  0/49 (0.00%)  6/89 (6.74%) 
Lymphadenopathy † 1  0/48 (0.00%)  0/49 (0.00%)  8/89 (8.99%) 
Gastrointestinal disorders       
Dental caries † 1  1/48 (2.08%)  1/49 (2.04%)  22/89 (24.72%) 
Diarrhoea † 1  4/48 (8.33%)  1/49 (2.04%)  20/89 (22.47%) 
Gastritis † 1  2/48 (4.17%)  1/49 (2.04%)  8/89 (8.99%) 
Vomiting † 1  6/48 (12.50%)  0/49 (0.00%)  11/89 (12.36%) 
General disorders       
Pyrexia † 1  1/48 (2.08%)  3/49 (6.12%)  14/89 (15.73%) 
Infections and infestations       
Abscess limb † 1  1/48 (2.08%)  1/49 (2.04%)  5/89 (5.62%) 
Acarodermatitis † 1  0/48 (0.00%)  0/49 (0.00%)  8/89 (8.99%) 
Bronchitis † 1  2/48 (4.17%)  1/49 (2.04%)  6/89 (6.74%) 
Conjunctivitis † 1  2/48 (4.17%)  0/49 (0.00%)  7/89 (7.87%) 
Fungal skin infection † 1  0/48 (0.00%)  0/49 (0.00%)  6/89 (6.74%) 
Gastroenteritis † 1  3/48 (6.25%)  4/49 (8.16%)  18/89 (20.22%) 
Impetigo † 1  0/48 (0.00%)  2/49 (4.08%)  10/89 (11.24%) 
Lice infestation † 1  0/48 (0.00%)  1/49 (2.04%)  5/89 (5.62%) 
Oral herpes † 1  2/48 (4.17%)  1/49 (2.04%)  9/89 (10.11%) 
Otitis media † 1  7/48 (14.58%)  4/49 (8.16%)  16/89 (17.98%) 
Pharyngitis † 1  1/48 (2.08%)  0/49 (0.00%)  16/89 (17.98%) 
Pharyngotonsillitis † 1  1/48 (2.08%)  1/49 (2.04%)  14/89 (15.73%) 
Sinusitis † 1  3/48 (6.25%)  1/49 (2.04%)  5/89 (5.62%) 
Tinea versicolour † 1  1/48 (2.08%)  1/49 (2.04%)  8/89 (8.99%) 
Upper respiratory tract infection † 1  6/48 (12.50%)  4/49 (8.16%)  10/89 (11.24%) 
Varicella † 1  0/48 (0.00%)  1/49 (2.04%)  10/89 (11.24%) 
Viral upper respiratory tract infection † 1  17/48 (35.42%)  17/49 (34.69%)  57/89 (64.04%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  0/48 (0.00%)  1/49 (2.04%)  15/89 (16.85%) 
Myalgia † 1  0/48 (0.00%)  0/49 (0.00%)  6/89 (6.74%) 
Nervous system disorders       
Headache † 1  1/48 (2.08%)  0/49 (0.00%)  14/89 (15.73%) 
Renal and urinary disorders       
Proteinuria † 1  1/48 (2.08%)  1/49 (2.04%)  5/89 (5.62%) 
Respiratory, thoracic and mediastinal disorders       
Asthmatic crisis † 1  0/48 (0.00%)  1/49 (2.04%)  5/89 (5.62%) 
Cough † 1  6/48 (12.50%)  7/49 (14.29%)  20/89 (22.47%) 
Nasal congestion † 1  0/48 (0.00%)  2/49 (4.08%)  8/89 (8.99%) 
Rhinitis allergic † 1  4/48 (8.33%)  0/49 (0.00%)  12/89 (13.48%) 
Skin and subcutaneous tissue disorders       
Acne † 1  0/48 (0.00%)  0/49 (0.00%)  8/89 (8.99%) 
1
Term from vocabulary, MedDRA 20.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures & Transparency
Organization: Gilead Sciences
EMail: GileadClinicalTrials@gilead.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00528957    
Other Study ID Numbers: GS-US-104-0352
2007-003418-32 ( EudraCT Number )
First Submitted: January 3, 2007
First Posted: September 14, 2007
Results First Submitted: February 15, 2012
Results First Posted: March 22, 2012
Last Update Posted: March 14, 2018