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Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children

This study has been completed.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PENTA Foundation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00039741
First received: June 7, 2002
Last updated: March 26, 2012
Last verified: March 2012
History of Changes
Results First Received: December 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT)
Drug: NNRTIs (EFV, NVP)
Drug: PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)

  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
Recruited at Pediatric AIDS Clinical Trials Group (PACTG) units in the U.S. and Puerto Rico, and Paediatric European Network for Treatment of AIDS (PENTA) units in Argentina, Austria, the Bahamas, Brazil, France, Germany, Italy, Romania, Spain, the United Kingdom and Ireland. Enrollment started 9/25/02 and ended 9/7/05.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were stratified by age (<3 years versus 3+ years), origin (PACTG site or PENTA site), and exposure versus no exposure to antiretroviral therapy perinatally. 266 children were randomized, of whom 3 are excluded from all analyses (2 had consent withdrawn by parents after randomization, 1 was ineligible).

Reporting Groups
  Description
PI/1K Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
NNRTI/1K 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
PI/30K Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
NNRTI/30K 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher

Participant Flow:   Overall Study
    PI/1K     NNRTI/1K     PI/30K     NNRTI/30K  
STARTED     66     68     65     64  
Death     0     1     0     0  
COMPLETED     51     56     54     50  
NOT COMPLETED     15     12     11     14  
Death                 0                 1                 0                 0  
Lost to Follow-up                 3                 1                 5                 2  
Confounding medical condition                 1                 0                 0                 0  
Not able to get to clinic                 5                 2                 0                 3  
Moved                 3                 2                 3                 6  
Non-compliance with protocol                 1                 0                 1                 0  
Withdrew consent                 0                 5                 0                 1  
Missed final visit                 2                 1                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
PI/1K Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
NNRTI/1K 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
PI/30K Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
NNRTI/30K 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
Total Total of all reporting groups

Baseline Measures
    PI/1K     NNRTI/1K     PI/30K     NNRTI/30K     Total  
Number of Participants  
[units: participants]
 		  66     68     65     64     263  
Age  
[units: years]
Mean ± Standard Deviation 		  8.0  ± 5.7     7.0  ± 5.4     7.9  ± 5.4     6.9  ± 5.0     7.5  ± 5.4  
Age, Customized  
[units: participants]
 		         
>30 days to <=12 months     10     12     7     11     40  
>12 months to <=3 years     8     7     8     5     28  
>3 to <=9 years     19     27     24     29     99  
>9 to <=14 years     14     13     13     10     50  
>14 years to <18 years     15     9     13     9     46  
Gender  
[units: participants]
 		         
Female     30     33     32     32     127  
Male     36     35     33     32     136  
Region of Enrollment [1]
[units: participants]
 		         
United States     18     20     16     18     72  
Puerto Rico     1     1     1     0     3  
Argentina     1     4     3     3     11  
Austria     1     0     0     1     2  
Bahamas     2     0     2     0     4  
Brazil     12     11     9     9     41  
France     3     3     5     6     17  
Germany     5     6     3     7     21  
Italy     7     4     5     6     22  
Romania     8     7     9     7     31  
Spain     1     0     1     0     2  
United Kingdom     7     11     9     6     33  
Ireland     0     1     2     1     4  
Viral Load [2]
[units: Log10 copies/ml]
Mean ± Standard Deviation 		  5.2  ± 0.8     5.0  ± 0.8     5.0  ± 0.8     5.1  ± 0.8     5.1  ± 0.8  
PENTA/PACTG site  
[units: participants]
 		         
PENTA     47     47     48     46     188  
PACTG     19     21     17     18     75  
CD4 percent (percentage of total lymphocytes that are CD4 cells)  
[units: CD4%]
Mean ± Standard Deviation 		  18  ± 12     18  ± 10     18  ± 11     17  ± 12     18  ± 11  
[1] Sites in the US and Puerto Rico were enrolled through PACTG, and other sites were enrolled through PENTA
[2] Log10 HIV-1 RNA (copies/ml)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml   [ Time Frame: Baseline visit and 4 years after Study Entry ]
  Show Outcome Measure 1

2.  Secondary:   Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced   [ Time Frame: Up to 6 yrs. (average 4.85 yrs.) ]
  Show Outcome Measure 2

3.  Secondary:   Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death   [ Time Frame: Up to 6 yrs. (average 4.85 yrs.) ]
  Show Outcome Measure 3

4.  Secondary:   Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen)   [ Time Frame: Up to 6 yrs. (average 4.85 yrs.) ]
  Show Outcome Measure 4

5.  Secondary:   Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy   [ Time Frame: Up to 6 yrs. (average 4.85 yrs.) ]
  Show Outcome Measure 5

6.  Secondary:   Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy   [ Time Frame: Up to 6 yrs. (average 4.85 yrs.) ]
  Show Outcome Measure 6

7.  Secondary:   Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204   [ Time Frame: Week 204 ]
  Show Outcome Measure 7

8.  Secondary:   Change in CD4% From Randomization to 4 Years   [ Time Frame: Randomization to 4 years ]
  Show Outcome Measure 8

9.  Secondary:   Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks   [ Time Frame: 24 weeks ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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: ClinicalTrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: 617-432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications of Results:

Other Publications:


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00039741     History of Changes
Other Study ID Numbers: P390, PENPACT-1B, 10106, PENTA 9/PACTG 390
Study First Received: June 7, 2002
Results First Received: December 19, 2011
Last Updated: March 26, 2012
Health Authority: United States: Food and Drug Administration