Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART) (PUSH)
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|ClinicalTrials.gov Identifier: NCT02063880|
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : July 25, 2017
Last Update Posted : May 14, 2018
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Design: Randomized clinical trial involving hospitalized HIV-1 infected children. Children will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy (7-14 days). This trial will be unblinded.
Population: Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve ≤ 12 years of age.
Sample size: 360 children will be randomized (180 per arm).
Treatment: All infants will be treated with ART according to World Health Organization (WHO) and Kenyan national guidelines.
Study duration: Enrollment into the study will occur over the course of 36-48 months and each infant will be routinely followed for a maximum of 6 months.
Study site: Kenyan hospitals.
HIV-1 infected children hospitalized with severe co-infection either may be unsalvageable due to too far advanced immunosuppression/co-infection or may benefit from urgent ART.
Urgent ART during an acute infection could potentially result in increased risk of immune reconstitution inflammatory syndrome (IRIS) or drug toxicities/interactions.
- To compare the 6 month all-cause mortality rate, incidence of immune reconstitution inflammatory syndrome (IRIS), and incidence of drug toxicity in HIV-1 infected children (≤ 12 years old) presenting to hospital with a serious infection randomized to urgent (<48 hours) versus early ART (7-14 days).
- To determine co-factors for mortality, IRIS, and drug toxicity. Potential cofactors will include: baseline weight-for-age, height-for-age, weight-for-height (Z-scores), CD4, HIV-1 RNA, type of co-infection, age, rate of viral load and CD4 change following ART, immune activation markers, pathogen and HIV-1 specific immune responses.
Secondary aim: To determine etiologies of IRIS and to compare immune reconstitution to HIV, TB, EBV and CMV following ART overall and in each trial arm.
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus Immune Reconstitution Inflammatory Syndrome||Other: Urgent ART Other: Early ART||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Urgent Versus Post-Stabilization ART in HIV-1 Infected Children With Severe Co-Infections|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: 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.
Other: Urgent ART
Children will be started on HAART <48 hours after enrollment.
Other Name: HAART regimens recommended by WHO and Kenya MOH.
Active Comparator: Early ART
Initiation of HAART 7-14 days after enrollment.
Other: Early ART
Children will be started on ART after stabilization 7-14 days after enrollment.
- All-cause Mortality [ Time Frame: 6 months post-HAART initiation ]
- Number of Participants With Evidence of Immune Reconstitution and Inflammatory Syndrome (IRIS) [ Time Frame: 6 months post-HAART initiation ]Confirmed, possible or likely IRIS based on external independent review
- Number of Participants With Potential Drug Toxicity [ Time Frame: 6 months post-HAART initiation ]Participants with adverse events that are deemed to be potentially related to medications.
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|Ages Eligible for Study:||up to 12 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Aged ≤ 12 years old (reported)
- HIV-1 positive (for example, two rapid HIV-1 antibody tests for children >18 months and not breastfeeding, or one HIV-1 DNA/RNA test for children ≤18 months or who are breastfeeding)
- Not currently receiving antiretroviral therapy (history of pMTCT does not affect eligibility)
- Eligible to receive ART, according to current WHO guidelines
- Caregiver plans to reside in study catchment area for at least 6 months (reported)
- Caregiver provides sufficient locator information
- Suspected meningitis, any other central nervous system infection, or encephalitis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063880
|Kisumu District Hospital|
|Mbagathi District Hospital|
|Nairobi, Kenya, 0202|
|Kenyatta National Hospital|
|Principal Investigator:||Grace John Stewart, MD, PhD||University of Washington|
|Responsible Party:||Grace John-Stewart, Professor, Global Health, University of Washington|
|Other Study ID Numbers:||
2R01HD023412-21 ( U.S. NIH Grant/Contract )
|First Posted:||February 17, 2014 Key Record Dates|
|Results First Posted:||July 25, 2017|
|Last Update Posted:||May 14, 2018|
|Last Verified:||April 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||after primary and secondary outcomes are published|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Acquired Immunodeficiency Syndrome
Immune Reconstitution Inflammatory Syndrome
Immunologic Deficiency Syndromes
Immune System Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases