Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya

This study has been terminated.
(DSMB recommended termination because TI was safe but not durable.)
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Nairobi
Information provided by (Responsible Party):
Grace John-Stewart, University of Washington
ClinicalTrials.gov Identifier:
NCT00428116
First received: January 22, 2007
Last updated: July 24, 2015
Last verified: July 2015
Results First Received: June 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: HAART

  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
Infants were identified from Nairobi City Council clinics, the Kenyatta National Hospital (KNH) wards, and the HIV treatment clinic. Recruitment occurred from 2007-2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 140 infants enrolled, 37 infants died, 11 were lost, and 7 were withdrawn. Of 75 infants who completed 2 years ART pre-randomization, 33 were ineligible for randomization and 42 were randomized.

Reporting Groups
  Description
Continued HAART After 24 months of HAART, infants were continued on HAART.
Interrupted HAART After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.

Participant Flow:   Overall Study
    Continued HAART     Interrupted HAART  
STARTED     21     21  
COMPLETED     18     21  
NOT COMPLETED     3     0  
Death                 1                 0  
Withdrawal by Subject                 1                 0  
Lost to Follow-up                 1                 0  



  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.
following 24 months of HAART

Reporting Groups
  Description
Continued HAART After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
Interrupted HAART After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
Total Total of all reporting groups

Baseline Measures
    Continued HAART     Interrupted HAART     Total  
Number of Participants  
[units: participants]
  21     21     42  
Age  
[units: participants]
     
<=18 years     21     21     42  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: months]
Median (Inter-Quartile Range)
  29   (28.8 to 33.8)     30.0   (29.3 to 34.9)     30.0   (28.9 to 34.6)  
Gender  
[units: participants]
     
Female     15     8     23  
Male     6     13     19  
Region of Enrollment  
[units: participants]
     
Kenya     21     21     42  
CD4%  
[units: percent]
Median (Inter-Quartile Range)
  33   (30 to 40)     34   (32 to 38)     33   (30 to 39)  
Log10 HIV RNA level  
[units: copies/ml]
Median (Inter-Quartile Range)
  2.18   (2.18 to 2.64)     2.18   (2.18 to 2.71)     2.18   (2.18 to 2.71)  



  Outcome Measures
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1.  Primary:   Growth at 18 Months Post-randomization   [ Time Frame: 18 months of post-randomization follow-up ]

2.  Secondary:   Morbidity   [ Time Frame: 18 months 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 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: 206 543 4278
e-mail: gjohn@uw.edu


No publications provided


Responsible Party: Grace John-Stewart, University of Washington
ClinicalTrials.gov Identifier: NCT00428116     History of Changes
Other Study ID Numbers: 30201-D, 2 RO1 HD023412-16;, 06-1885-D 02
Study First Received: January 22, 2007
Results First Received: June 8, 2015
Last Updated: July 24, 2015
Health Authority: United States: Institutional Review Board