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Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya

This study has been terminated.
(DSMB recommended termination because TI was safe but not durable.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428116
First Posted: January 29, 2007
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fred Hutchinson Cancer Research Center
University of Nairobi
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Grace John-Stewart, University of Washington
Results First Submitted: June 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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Of 140 infants enrolled, 37 infants died, 11 were lost, and 7 were withdrawn.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 
Overall Participants Analyzed 
[Units: Participants]
 21   21   42 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      21 100.0%      21 100.0%      42 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  71.4%      8  38.1%      23  54.8% 
Male      6  28.6%      13  61.9%      19  45.2% 
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
  Show All Outcome Measures

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


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Grace John-Stewart, University of Washington
ClinicalTrials.gov Identifier: NCT00428116     History of Changes
Other Study ID Numbers: 30201-D
R01HD023412 ( U.S. NIH Grant/Contract )
First Submitted: January 22, 2007
First Posted: January 29, 2007
Results First Submitted: June 8, 2015
Results First Posted: August 20, 2015
Last Update Posted: May 3, 2017