Trial Outcomes & Findings for Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya (NCT NCT00428116)
NCT ID: NCT00428116
Last Updated: 2018-07-26
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
18 months of post-randomization follow-up
Results posted on
2018-07-26
Participant Flow
Infants were identified from Nairobi City Council clinics, the Kenyatta National Hospital (KNH) wards, and the HIV treatment clinic. Recruitment occurred from 2007-2009.
Of 140 infants enrolled, 37 infants died, 11 were lost, and 7 were withdrawn.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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya
Baseline characteristics by cohort
| Measure |
Continued HAART
n=21 Participants
After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
|
Interrupted HAART
n=21 Participants
After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29 months
n=5 Participants
|
30.0 months
n=7 Participants
|
30.0 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
CD4%
|
33 percent
n=5 Participants
|
34 percent
n=7 Participants
|
33 percent
n=5 Participants
|
|
Log10 HIV RNA level
|
2.18 copies/ml
n=5 Participants
|
2.18 copies/ml
n=7 Participants
|
2.18 copies/ml
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 months of post-randomization follow-upWeight 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.
Outcome measures
| Measure |
Continued HAART
n=21 Participants
After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
|
Interrupted HAART
n=21 Participants
After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
|
|---|---|---|
|
Growth at 18 Months Post-randomization
WAZ (z-score)
|
-0.57 z-score
Interval -0.88 to -0.28
|
-0.17 z-score
Interval -0.56 to 0.37
|
|
Growth at 18 Months Post-randomization
HAZ (z-score)
|
-1.04 z-score
Interval -1.58 to -0.59
|
-0.78 z-score
Interval -1.62 to 0.0
|
SECONDARY outcome
Timeframe: 18 months post-randomizationsevere adverse events including death, pneumonia, diarrhea, and other adverse events
Outcome measures
| Measure |
Continued HAART
n=21 Participants
After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
|
Interrupted HAART
n=21 Participants
After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
|
|---|---|---|
|
Morbidity
Severe adverse events
|
2 participants
|
1 participants
|
|
Morbidity
Pneumonia
|
4 participants
|
3 participants
|
|
Morbidity
Diarrhea
|
7 participants
|
12 participants
|
|
Morbidity
Death
|
1 participants
|
0 participants
|
Adverse Events
Continued HAART
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Interrupted HAART
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continued HAART
n=21 participants at risk
After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
|
Interrupted HAART
n=21 participants at risk
After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
|
|---|---|---|
|
Infections and infestations
Death
|
4.8%
1/21 • Number of events 1 • 18 months post-randomization
|
0.00%
0/21 • 18 months post-randomization
|
|
Hepatobiliary disorders
Hepatotoxicity
|
4.8%
1/21 • 18 months post-randomization
|
4.8%
1/21 • 18 months post-randomization
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/21 • 18 months post-randomization
|
4.8%
1/21 • 18 months post-randomization
|
Other adverse events
| Measure |
Continued HAART
n=21 participants at risk
After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
|
Interrupted HAART
n=21 participants at risk
After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
100.0%
21/21 • 18 months post-randomization
|
95.2%
20/21 • 18 months post-randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
19.0%
4/21 • 18 months post-randomization
|
14.3%
3/21 • 18 months post-randomization
|
|
Metabolism and nutrition disorders
High cholesterol
|
47.6%
10/21 • 18 months post-randomization
|
19.0%
4/21 • 18 months post-randomization
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
7/21 • 18 months post-randomization
|
57.1%
12/21 • 18 months post-randomization
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
23.8%
5/21 • 18 months post-randomization
|
66.7%
14/21 • 18 months post-randomization
|
|
Skin and subcutaneous tissue disorders
Rash
|
52.4%
11/21 • 18 months post-randomization
|
52.4%
11/21 • 18 months post-randomization
|
|
Blood and lymphatic system disorders
Anemia
|
57.1%
12/21 • 18 months post-randomization
|
76.2%
16/21 • 18 months post-randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place