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Trial record 10 of 30 for:    " January 10, 2007":" February 09, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya

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ClinicalTrials.gov Identifier: NCT00428116
Recruitment Status : Terminated (DSMB recommended termination because TI was safe but not durable.)
First Posted : January 29, 2007
Results First Posted : August 20, 2015
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Nairobi
National Institutes of Health (NIH)
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
Intervention Drug: HAART
Enrollment 140
Recruitment Details 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Pre-assignment Details Of 140 infants enrolled, 37 infants died, 11 were lost, and 7 were withdrawn.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.
Arm/Group Title Continued HAART Interrupted HAART
Hide Arm/Group Description After 24 months of HAART, infants were continued on HAART. After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
Period Title: Overall Study
Started 21 21
Completed 18 21
Not Completed 3 0
Reason Not Completed
Death             1             0
Withdrawal by Subject             1             0
Lost to Follow-up             1             0
Arm/Group Title Continued HAART Interrupted HAART Total
Hide Arm/Group Description After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months. After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months. Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
following 24 months of HAART
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 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, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 21 participants 21 participants 42 participants
29
(28.8 to 33.8)
30.0
(29.3 to 34.9)
30.0
(28.9 to 34.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
15
  71.4%
8
  38.1%
23
  54.8%
Male
6
  28.6%
13
  61.9%
19
  45.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Kenya Number Analyzed 21 participants 21 participants 42 participants
21 21 42
CD4%  
Median (Inter-Quartile Range)
Unit of measure:  Percent
Number Analyzed 21 participants 21 participants 42 participants
33
(30 to 40)
34
(32 to 38)
33
(30 to 39)
Log10 HIV RNA level  
Median (Inter-Quartile Range)
Unit of measure:  Copies/ml
Number Analyzed 21 participants 21 participants 42 participants
2.18
(2.18 to 2.64)
2.18
(2.18 to 2.71)
2.18
(2.18 to 2.71)
1.Primary Outcome
Title Growth at 18 Months Post-randomization
Hide Description Weight and height will be transformed to the weight-for-age Z-score (i.e., WAZ) and height-for-age Z-score (i.e., HAZ) using World Health Organization Child Growth Standards, taking into account the infant's age and gender.
Time Frame 18 months of post-randomization follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continued HAART Interrupted HAART
Hide Arm/Group Description:
After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: z-score
WAZ (z-score)
-0.57
(-0.88 to -0.28)
-0.17
(-0.56 to 0.37)
HAZ (z-score)
-1.04
(-1.58 to -0.59)
-0.78
(-1.62 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continued HAART, Interrupted HAART
Comments WAZ-score comparison at 18 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Continued HAART, Interrupted HAART
Comments HAZ score at 18 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Morbidity
Hide Description severe adverse events including death, pneumonia, diarrhea, and other adverse events
Time Frame 18 months post-randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continue HAART Interrupted HAART
Hide Arm/Group Description:
After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: participants
Severe adverse events 2 1
Pneumonia 4 3
Diarrhea 7 12
Death 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continue HAART, Interrupted HAART
Comments SAEs
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method log rank or Cox regression
Comments incidence with Cox regression utilized Anderson-Gill method to handle recurrent events
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Continue HAART, Interrupted HAART
Comments Pneumonia
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Cox regression Anderson Gill
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Continue HAART, Interrupted HAART
Comments Pneumonia
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Continue HAART, Interrupted HAART
Comments Diarrhea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Continue HAART, Interrupted HAART
Comments Death
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame 18 months post-randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continued HAART Interrupted HAART
Hide Arm/Group Description After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months. After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
All-Cause Mortality
Continued HAART Interrupted HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Continued HAART Interrupted HAART
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/21 (9.52%)      1/21 (4.76%)    
Hepatobiliary disorders     
Hepatotoxicity   1/21 (4.76%)  1/21 (4.76%) 
Infections and infestations     
Death   1/21 (4.76%)  1 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cellulitis   0/21 (0.00%)  1/21 (4.76%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Continued HAART Interrupted HAART
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/21 (100.00%)      21/21 (100.00%)    
Blood and lymphatic system disorders     
Lymphadenopathy   5/21 (23.81%)  14/21 (66.67%) 
Anemia   12/21 (57.14%)  16/21 (76.19%) 
Gastrointestinal disorders     
Diarrhea   7/21 (33.33%)  12/21 (57.14%) 
Metabolism and nutrition disorders     
High cholesterol   10/21 (47.62%)  4/21 (19.05%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection   21/21 (100.00%)  20/21 (95.24%) 
Pneumonia   4/21 (19.05%)  3/21 (14.29%) 
Skin and subcutaneous tissue disorders     
Rash   11/21 (52.38%)  11/21 (52.38%) 
Indicates events were collected by systematic assessment
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
EMail: gjohn@uw.edu
Publications of Results:
Responsible Party: Grace John-Stewart, University of Washington
ClinicalTrials.gov Identifier: NCT00428116     History of Changes
Other Study ID Numbers: STUDY00001675
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: July 25, 2018