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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
127 participants were screened.

Reporting Groups
  Description
Tenofovir DF 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).
Stavudine or Zidovudine Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).

Participant Flow for 5 periods

Period 1:   Randomized Phase (Baseline to Week 48)
    Tenofovir DF   Stavudine or Zidovudine
STARTED   48   49 
COMPLETED   44   48 
NOT COMPLETED   4   1 
Withdrew Consent                2                1 
Safety, Tolerability, or Efficacy Reason                2                0 

Period 2:   First Extension (Week 48 to Week 144)
    Tenofovir DF   Stavudine or Zidovudine
STARTED   38 [1]   41 [2] 
COMPLETED   35   40 
NOT COMPLETED   3   1 
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 3:   Second Extension (Week 144 to Week 240)
    Tenofovir DF   Stavudine or Zidovudine
STARTED   34 [1]   40 
COMPLETED   27   37 
NOT COMPLETED   7   3 
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 4:   Third Extension (Week 240 to Week 336)
    Tenofovir DF   Stavudine or Zidovudine
STARTED   27   37 
COMPLETED   21   27 
NOT COMPLETED   6   10 
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 5:   Long-Term Extension (Week 336 and On)
    Tenofovir DF   Stavudine or Zidovudine
STARTED   19 [1]   25 [1] 
COMPLETED   9   8 
NOT COMPLETED   10   17 
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.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized and Treated Set: participants who were randomized and received at least 1 dose of study drug

Reporting Groups
  Description
Tenofovir DF Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
Stavudine or Zidovudine Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
Total Total of all reporting groups

Baseline Measures
   Tenofovir DF   Stavudine or Zidovudine   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   49   97 
Age 
[Units: Years]
Mean (Standard Deviation)
 7  (3.3)   7  (2.6)   7  (3.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  56.3%      20  40.8%      47  48.5% 
Male      21  43.8%      29  59.2%      50  51.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   13   9   22 
Panama   33   39   72 
United Kingdom   2   1   3 
Height 
[Units: Cm]
Mean (Standard Deviation)
 118  (19.8)   119  (16.7)   119  (18.2) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 17.59  (3.680)   16.59  (1.762)   17.08  (2.905) 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 25.9  (12.03)   24.1  (7.77)   25.0  (10.09) 
Plasma HIV-1 RNA 
[Units: Participants]
Count of 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 
[Units: Cells/mm^3]
Mean (Standard Deviation)
 1190  (541.7)   1144  (388.4)   1167  (468.6) 
CD4 Percentage 
[Units: Percentage]
Mean (Standard Deviation)
 33.9  (7.44)   33.0  (6.82)   33.5  (7.11) 


  Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48   [ Time Frame: 48 weeks ]

2.  Secondary:   Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)   [ Time Frame: 48 weeks ]

3.  Secondary:   Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)   [ Time Frame: 48 weeks ]

4.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96   [ Time Frame: 96 weeks ]

5.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144   [ Time Frame: 144 weeks ]

6.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks   [ Time Frame: 192 weeks ]

7.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks   [ Time Frame: 240 weeks ]

8.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks   [ Time Frame: 288 weeks ]

9.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks   [ Time Frame: 336 weeks ]

10.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks   [ Time Frame: 384 weeks ]

11.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks   [ Time Frame: 432 weeks ]

12.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks   [ Time Frame: 480 weeks ]

13.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks   [ Time Frame: 528 weeks ]

14.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks   [ Time Frame: 48 weeks ]

15.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks   [ Time Frame: 96 weeks ]

16.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks   [ Time Frame: 144 weeks ]

17.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks   [ Time Frame: 192 weeks ]

18.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks   [ Time Frame: 240 weeks ]

19.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks   [ Time Frame: 288 weeks ]

20.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks   [ Time Frame: 336 weeks ]

21.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks   [ Time Frame: 384 weeks ]

22.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks   [ Time Frame: 432 weeks ]

23.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks   [ Time Frame: 480 weeks ]

24.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks   [ Time Frame: 528 weeks ]

25.  Secondary:   Change From Baseline in CD4 Percentage at 48 Weeks   [ Time Frame: Baseline and 48 weeks ]

26.  Secondary:   Change From Baseline in CD4 Percentage at 96 Weeks   [ Time Frame: Baseline and 96 weeks ]

27.  Secondary:   Change From Baseline in CD4 Percentage at 144 Weeks   [ Time Frame: Baseline and 144 weeks ]

28.  Secondary:   Change From Baseline in CD4 Percentage at 192 Weeks   [ Time Frame: Baseline and 192 weeks ]

29.  Secondary:   Change From Baseline in CD4 Percentage at 240 Weeks   [ Time Frame: Baseline and 240 weeks ]

30.  Secondary:   Change From Baseline in CD4 Percentage at 288 Weeks   [ Time Frame: Baseline and 288 weeks ]

31.  Secondary:   Change From Baseline in CD4 Percentage at 336 Weeks   [ Time Frame: Baseline and 336 weeks ]

32.  Secondary:   Change From Baseline in CD4 Percentage at 384 Weeks   [ Time Frame: Baseline and 384 weeks ]

33.  Secondary:   Change From Baseline in CD4 Percentage at 432 Weeks   [ Time Frame: Baseline and 432 weeks ]

34.  Secondary:   Change From Baseline in CD4 Percentage at 480 Weeks   [ Time Frame: Baseline and 480 weeks ]

35.  Secondary:   Change From Baseline in CD4 Percentage at 528 Weeks   [ Time Frame: Baseline and 528 weeks ]

36.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks   [ Time Frame: Baseline and 48 weeks ]

37.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks   [ Time Frame: Baseline and 96 weeks ]

38.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks   [ Time Frame: Baseline and 144 weeks ]

39.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks   [ Time Frame: Baseline and 192 weeks ]

40.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks   [ Time Frame: Baseline and 240 weeks ]

41.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks   [ Time Frame: Baseline and 288 weeks ]

42.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks   [ Time Frame: Baseline and 336 weeks ]

43.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks   [ Time Frame: Baseline and 384 weeks ]

44.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks   [ Time Frame: Baseline and 432 weeks ]

45.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks   [ Time Frame: Baseline and 480 weeks ]

46.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks   [ Time Frame: Baseline and 528 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures & Transparency
Organization: Gilead Sciences
e-mail: GileadClinicalTrials@gilead.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00528957     History of Changes
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