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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00528957
First received: January 3, 2007
Last updated: October 17, 2013
Last verified: October 2013
Results First Received: February 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Tenofovir DF
Drug: Zidovudine
Drug: Stavudine

  Participant Flow
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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 a total of 9 study sites; 6 in the US, 1 in Panama, and 2 in the UK. The first participant was screened on 28 December 2006, and the last participant was randomized on 14 March 2008. The last participant observation (LPO) for the Week 48 was 06 April 2009. The LPO for the Week 144 analysis was 21 February 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 127 screened, 97 were randomized.

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).

Participant Flow for 3 periods

Period 1:   Randomized Phase (Baseline to Week 48)
    Tenofovir DF     Stavudine or Zidovudine  
STARTED     48     49  
COMPLETED     44     48  
NOT COMPLETED     4     1  
Withdrawal by Subject                 2                 1  
Lack of Efficacy                 1                 0  
Intolerability to oral powder                 1                 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  
Physician Decision                 2                 0  
Withdrawal by Subject                 0                 1  
Adverse Event                 1                 0  
[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     0 [2]   0 [2]
NOT COMPLETED     34     40  
Study Ongoing                 28                 38  
Physician Decision                 2                 0  
Adverse Event                 2                 2  
Lack of Efficacy                 1                 0  
Poor adherence                 1                 0  
[1] One participant completed the first extension and did not enroll in the second extension.
[2] Study is ongoing, therefore no participants have completed the study.



  Baseline Characteristics
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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.
No text entered.

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  
Number of Participants  
[units: participants]
  48     49     97  
Age  
[units: years]
Mean ± Standard Deviation
  7  ± 3.3     7  ± 2.6     7  ± 3.0  
Gender  
[units: participants]
     
Female     27     20     47  
Male     21     29     50  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     35     42     77  
Not Hispanic or Latino     13     7     20  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     13     6     19  
White     3     6     9  
Mestizo     28     37     65  
Native Indian (Kuna)     1     0     1  
Region of Enrollment  
[units: 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  



  Outcome Measures
  Show All 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:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96   [ Time Frame: 96 weeks ]

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

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

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

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

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

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

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

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

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

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

14.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks   [ Time Frame: 192 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks   [ Time Frame: 240 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks   [ Time Frame: 288 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks   [ Time Frame: 336 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

18.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks   [ Time Frame: 192 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

19.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks   [ Time Frame: 240 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

20.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks   [ Time Frame: 288 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

21.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks   [ Time Frame: 336 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

22.  Secondary:   Change From Baseline in CD4 Percentage at 192 Weeks   [ Time Frame: Baseline and 192 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

23.  Secondary:   Change From Baseline in CD4 Percentage at 240 Weeks   [ Time Frame: Baseline and 240 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

24.  Secondary:   Change From Baseline in CD4 Percentage at 288 Weeks   [ Time Frame: Baseline and 288 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

25.  Secondary:   Change From Baseline in CD4 Percentage at 336 Weeks   [ Time Frame: Baseline and 336 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

26.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks   [ Time Frame: Baseline and 192 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

27.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks   [ Time Frame: Baseline and 240 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

28.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks   [ Time Frame: Baseline and 288 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

29.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks   [ Time Frame: Baseline and 336 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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.  


Results Point of Contact:  
Name/Title: Dara Wambach, MA, Associate Director, Regulatory Affairs
Organization: Gilead Sciences
phone: 650 522 5163
e-mail: Dara.Wambach@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00528957     History of Changes
Other Study ID Numbers: GS-US-104-0352
Study First Received: January 3, 2007
Results First Received: February 15, 2012
Last Updated: October 17, 2013
Health Authority: United States: Food and Drug Administration