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Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya

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ClinicalTrials.gov Identifier: NCT00427297
Recruitment Status : Terminated (There is no longer equipoise. DSMB recommended termination.)
First Posted : January 29, 2007
Results First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Grace John-Stewart, University of Washington

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: AZT/3TC/NVP (zidovudine/lamivudine/nevirapine)
Drug: d4T/3TC/NVP (stavudine/lamivudine/nevirapine)
Drug: AZT/3TC/ABC (zidovudine/lamivudine/abacavir)
Drug: d4T/3TC/ABC (stavudine/lamivudine/abacavir)
Drug: ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir)
Drug: ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz)
Drug: ABC/3TC/NVP (abacavir/lamivudine/nevirapine)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
NVP-containing

Infants randomized to this arm will receive nevirapine-containing HAART regimen

AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen

d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen

ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen

NVP-sparing

Infants randomized to this arm will receive nevirapine-sparing HAART

AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen

d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of<8g/dl), AZT will be substituted for d4T.

ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen

ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.


Participant Flow:   Overall Study
    NVP-containing   NVP-sparing
STARTED   17   17 
COMPLETED   17   17 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
NVP-containing

Infants randomized to this arm will receive nevirapine-containing HAART regimen

AZT/3TC/NVP (zidovudine/lamivudine/nevirapine): First line regimen

d4T/3TC/NVP (stavudine/lamivudine/nevirapine): First line regimen

ABC/3TC/NVP (abacavir/lamivudine/nevirapine): First line regimen

NVP-sparing

Infants randomized to this arm will receive nevirapine-sparing HAART

AZT/3TC/ABC (zidovudine/lamivudine/abacavir): First line regimen

d4T/3TC/ABC (stavudine/lamivudine/abacavir): First line regimen For children who have anaemia(Hb of<8g/dl), AZT will be substituted for d4T.

ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir): Second line regimen

ABC/ ddI or TDF / NVP or EFV (abacavir / didanosine or tenofovir / nevirapine or efavirenz): Second line regimen - Among children randomized to NVP sparing HAART, who will be initiated on a regimen containing lopinavir/ritonavir, zidovudine and lamivudine will be substituted with abacavir and didanosine or tenofovir (TDF) and lopinavir/ ritonavir will be replaced with nevirapine or efavirenz (EFV) in case of treatment failure of the LPV/r containing regimen.

Total Total of all reporting groups

Baseline Measures
   NVP-containing   NVP-sparing   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   17   34 
Age 
[Units: Months]
Median (Inter-Quartile Range)
 7 
 (6 to 10) 
 8 
 (6 to 10) 
 7 
 (6 to 10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  47.1%      7  41.2%      15  44.1% 
Male      9  52.9%      10  58.8%      19  55.9% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Kenya   17   17   34 
CD4% 
[Units: Percentage of cells]
Median (Inter-Quartile Range)
 22 
 (14 to 29) 
 18 
 (13 to 25) 
 21.5 
 (13 to 27) 


  Outcome Measures

1.  Primary:   Incidence of Mortality   [ Time Frame: 2 years ]

2.  Primary:   Immunologic Failure   [ Time Frame: 2 years ]

3.  Primary:   Viral Failure   [ Time Frame: 2 years ]

4.  Secondary:   Incidence of Severe Adverse Events (Excluding Mortality)   [ Time Frame: 2 years ]


  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
The study team suggested discontinuation of the trial and the DSMB concurred based on slow accrual and based on new data that emerged after the RCT was initiated which made the trial question less relevant.


  More Information

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.


Results Point of Contact:  
Name/Title: Grace John-Stewart
Organization: University of Washington
phone: 206 5434278
e-mail: gjohn@uw.edu



Responsible Party: Grace John-Stewart, University of Washington
ClinicalTrials.gov Identifier: NCT00427297     History of Changes
Other Study ID Numbers: STUDY00002049
2R01HD023412-16 ( U.S. NIH Grant/Contract )
06-1886-D 02
First Submitted: January 22, 2007
First Posted: January 29, 2007
Results First Submitted: June 29, 2018
Results First Posted: August 27, 2018
Last Update Posted: August 27, 2018