Trial Outcomes & Findings for Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART) (NCT NCT02063880)

NCT ID: NCT02063880

Last Updated: 2018-05-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 183 participants
• Primary outcome timeframe: 6 months post-HAART initiation
• Results posted on: 2018-05-14

Participant Flow

Participant milestones

Measure	Urgent ART Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health. Urgent ART: Children will be started on HAART \<48 hours after enrollment.	Early ART Initiation of HAART 7-14 days after enrollment. Early ART: Children will be started on ART after stabilization 7-14 days after enrollment.
Overall Study STARTED	90	93
Overall Study COMPLETED	62	66
Overall Study NOT COMPLETED	28	27

Reasons for withdrawal

Measure	Urgent ART Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health. Urgent ART: Children will be started on HAART \<48 hours after enrollment.	Early ART Initiation of HAART 7-14 days after enrollment. Early ART: Children will be started on ART after stabilization 7-14 days after enrollment.
Overall Study Death	21	18
Overall Study Lost to Follow-up	7	7
Overall Study Ineligible	0	2

Baseline Characteristics

Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART)

Baseline characteristics by cohort

Measure	Urgent ART n=90 Participants Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health. Urgent ART: Children will be started on HAART \<48 hours after enrollment.	Early ART n=91 Participants Initiation of HAART 7-14 days after enrollment. Early ART: Children will be started on ART after stabilization 7-14 days after enrollment.	Total n=181 Participants Total of all reporting groups
Age, Continuous	2 Years n=5 Participants	1.8 Years n=7 Participants	1.9 Years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment Kenya	90 participants n=5 Participants	91 participants n=7 Participants	181 participants n=5 Participants
CD4%	12.5 % n=5 Participants	17 % n=7 Participants	14.5 % n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-HAART initiation

Outcome measures

Measure	Urgent ART n=90 Participants Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health. Urgent ART: Children will be started on HAART \<48 hours after enrollment.	Early ART n=91 Participants Initiation of HAART 7-14 days after enrollment. Early ART: Children will be started on ART after stabilization 7-14 days after enrollment.
All-cause Mortality	21 participants	18 participants

SECONDARY outcome

Timeframe: 6 months post-HAART initiation

Confirmed, possible or likely IRIS based on external independent review

Outcome measures

Measure	Urgent ART n=90 Participants Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health. Urgent ART: Children will be started on HAART \<48 hours after enrollment.	Early ART n=91 Participants Initiation of HAART 7-14 days after enrollment. Early ART: Children will be started on ART after stabilization 7-14 days after enrollment.
Number of Participants With Evidence of Immune Reconstitution and Inflammatory Syndrome (IRIS)	10 participants	12 participants

SECONDARY outcome

Timeframe: 6 months post-HAART initiation

Participants with adverse events that are deemed to be potentially related to medications.

Outcome measures

Measure	Urgent ART n=90 Participants Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health. Urgent ART: Children will be started on HAART \<48 hours after enrollment.	Early ART n=91 Participants Initiation of HAART 7-14 days after enrollment. Early ART: Children will be started on ART after stabilization 7-14 days after enrollment.
Number of Participants With Potential Drug Toxicity	23 participants	15 participants

Adverse Events

Urgent ART

Serious events: 34 serious events

Other events: 10 other events

Deaths: 21 deaths

Early ART

Serious events: 40 serious events

Other events: 12 other events

Deaths: 18 deaths

Serious adverse events

Measure	Urgent ART n=90 participants at risk Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health. Urgent ART: Children will be started on HAART \<48 hours after enrollment.	Early ART n=91 participants at risk Initiation of HAART 7-14 days after enrollment. Early ART: Children will be started on ART after stabilization 7-14 days after enrollment.
Infections and infestations Non-mortality SAE	14.4% 13/90 • Number of events 13 • 6 months	24.2% 22/91 • Number of events 22 • 6 months
Infections and infestations Mortality	23.3% 21/90 • Number of events 21 • 6 months	19.8% 18/91 • Number of events 18 • 6 months

Other adverse events

Measure	Urgent ART n=90 participants at risk Initiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health. Urgent ART: Children will be started on HAART \<48 hours after enrollment.	Early ART n=91 participants at risk Initiation of HAART 7-14 days after enrollment. Early ART: Children will be started on ART after stabilization 7-14 days after enrollment.
Blood and lymphatic system disorders IRIS	11.1% 10/90 • Number of events 10 • 6 months	13.2% 12/91 • Number of events 12 • 6 months

Additional Information

Grace John-Stewart

University of Washington

Phone: 206 5434278

Email: gjohn@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place