Treatment Options for Protease Inhibitor-exposed Children (NEVEREST-III)

This study has been completed.
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Louise Kuhn, Columbia University
ClinicalTrials.gov Identifier:
NCT01146873
First received: June 8, 2010
Last updated: March 31, 2016
Last verified: March 2016
Results First Received: February 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV/AIDS
HIV Infections
Interventions: Drug: Efavirenz (EFV)
Drug: Lopinavir/ritonavir (LPV/r)
Drug: Stavudine (D4T)
Drug: Abacavir (ABC)

  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
A total of 300 study participants were recruited between June 2010 and October 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two children discontinued the study prior to randomization.

Reporting Groups
  Description
Group 1: Lopinavir/Ritonavir (LPV/r) Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
Group 2: Efavirenz (EFV) Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.

Participant Flow:   Overall Study
    Group 1: Lopinavir/Ritonavir (LPV/r)     Group 2: Efavirenz (EFV)  
STARTED     148     150  
COMPLETED     148     144  
NOT COMPLETED     0     6  
Transfer out                 0                 6  



  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.
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Reporting Groups
  Description
Group 1: Lopinavir/Ritonavir (LPV/r) Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
Group 2: Efavirenz (EFV) Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
Total Total of all reporting groups

Baseline Measures
    Group 1: Lopinavir/Ritonavir (LPV/r)     Group 2: Efavirenz (EFV)     Total  
Number of Participants  
[units: participants]
  148     150     298  
Age  
[units: years]
Mean (Standard Deviation)
  4.26  (1.0)     4.28  (0.9)     4.27  (0.9)  
Gender  
[units: participants]
     
Female     80     78     158  
Male     68     72     140  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Viral Rebound   [ Time Frame: 48 weeks ]

2.  Primary:   Viral Failure   [ Time Frame: 48 weeks ]

3.  Secondary:   CD4 Cell Percentage at 48 Weeks After Randomization   [ Time Frame: 48 weeks ]

4.  Secondary:   Percentage of Participants With Elevated Total Cholesterol, Elevated LDL, Abnormal HDL, or Abnormal Triglycerides at 40 Weeks After Randomization   [ Time Frame: 40 weeks ]

5.  Secondary:   Highest Grade ALT After Randomization   [ Time Frame: through 48 weeks post randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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: Louise Kuhn, PhD
Organization: Columbia University
phone: 212-305-2398
e-mail: lk24@cumc.columbia.edu


Publications of Results:

Responsible Party: Louise Kuhn, Columbia University
ClinicalTrials.gov Identifier: NCT01146873     History of Changes
Other Study ID Numbers: AAAE1145
R01HD061255 ( US NIH Grant/Contract Award Number )
Study First Received: June 8, 2010
Results First Received: February 29, 2016
Last Updated: March 31, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council