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Human Immunodeficiency VirusPUSHNCT02063880

Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART)

A study testing Urgent ART and Early ART in people with Human Immunodeficiency Virus and Immune Reconstitution Inflammatory Syndrome, run by University of Washington at 4 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 12 years
What is being tested?
Urgent ART and Early ART
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
4 sitesKenya
Study dates
Mar 2013to Nov 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Suspected meningitis, any other central nervous system infection, or encephalitis

Trial locations and contacts

4 sites in 1 country.

Kenya4 sites

  • JOOTRH

    Kisumu

  • Kisumu District Hospital

    Kisumu

  • Mbagathi District Hospital

    Nairobi, 0202

  • Kenyatta National Hospital

    Nairobi

Other trials in Kenya

About this study

Official title: Urgent Versus Post-Stabilization ART in HIV-1 Infected Children With Severe Co-Infections

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.

Read more

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.

Primary hypothesis:

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.

Secondary hypotheses:

Urgent ART during an acute infection could potentially result in increased risk of immune reconstitution inflammatory syndrome (IRIS) or drug toxicities/interactions.

Specific aims:

  1. 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).
  2. 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.

Read the detailed description

Children will be followed and compared for 6-month mortality.

Being tested
Urgent ART, Early ART
Keywords
HIV-1, IRIS
Medical subject headings
Acquired Immunodeficiency Syndrome, Immune Reconstitution Inflammatory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urgent ARTOther

    Also called HAART regimens recommended by WHO and Kenya MOH.

    Children will be started on HAART <48 hours after enrollment.

  • Early ARTOther

    Children will be started on ART after stabilization 7-14 days after enrollment.

Study groups in NCT02063880
Study groupRoleWhat they receive
Urgent ARTExperimentalInitiation of highly active antiretroviral therapy (HAART) within 48 hours of enrollment. Antiretroviral therapy will include regimens recommended by the Kenyan Ministry of Health.
Receives: Other: Urgent ART
Early ARTActive comparatorInitiation of HAART 7-14 days after enrollment.
Receives: Other: Early ART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause Mortality

    Measured: 6 months post-HAART initiation

Secondary outcomes (2)

  1. Number of Participants With Evidence of Immune Reconstitution and Inflammatory Syndrome (IRIS)

    Confirmed, possible or likely IRIS based on external independent review

    Measured: 6 months post-HAART initiation

  2. Number of Participants With Potential Drug Toxicity

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

    Measured: 6 months post-HAART initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2014 (estimated)
  2. Study startMar 2013
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02063880
Sponsor's protocol ID
STUDY00001052
Other IDs
2R01HD023412-21
Acronym
PUSH
Status last verified
Apr 2018
First submitted
21 Aug 2012
Last updated
14 May 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: after primary and secondary outcomes are published

Publications

  • Cherkos AS, Cranmer LM, Njuguna I, LaCourse SM, Mugo C, Moraa H, Maleche-Obimbo E, Enquobahrie DA, Richardson BA, Wamalwa D, John-Stewart G. Effect of tuberculosis-HIV co-treatment on clinical and growth outcomes among hospitalized children newly initiating antiretroviral therapy. AIDS. 2024 Mar 15;38(4):579-588. doi: 10.1097/QAD.0000000000003797. Epub 2023 Nov 27.

    PubMed 38016160

  • Njuguna IN, Cranmer LM, Wagner AD, LaCourse SM, Mugo C, Benki-Nugent S, Richardson BA, Stern J, Maleche-Obimbo E, Wamalwa DC, John-Stewart G. Brief Report: Cofactors of Mortality Among Hospitalized HIV-Infected Children Initiating Antiretroviral Therapy in Kenya. J Acquir Immune Defic Syndr. 2019 Jun 1;81(2):138-144. doi: 10.1097/QAI.0000000000002012.

    PubMed 31095004

  • LaCourse SM, Cranmer LM, Njuguna IN, Gatimu J, Stern J, Maleche-Obimbo E, Walson JL, Wamalwa D, John-Stewart GC, Pavlinac PB. Urine Tuberculosis Lipoarabinomannan Predicts Mortality in Hospitalized Human Immunodeficiency Virus-Infected Children. Clin Infect Dis. 2018 May 17;66(11):1798-1801. doi: 10.1093/cid/ciy011.

    PubMed 29324985

  • Njuguna IN, Cranmer LM, Otieno VO, Mugo C, Okinyi HM, Benki-Nugent S, Richardson B, Stern J, Maleche-Obimbo E, Wamalwa DC, John-Stewart GC. Urgent versus post-stabilisation antiretroviral treatment in hospitalised HIV-infected children in Kenya (PUSH): a randomised controlled trial. Lancet HIV. 2018 Jan;5(1):e12-e22. doi: 10.1016/S2352-3018(17)30167-4. Epub 2017 Nov 14.

    PubMed 29150377

  • Wagner AD, Njuguna IN, Andere RA, Cranmer LM, Okinyi HM, Benki-Nugent S, Chohan BH, Maleche-Obimbo E, Wamalwa DC, John-Stewart GC. Infant/child rapid serology tests fail to reliably assess HIV exposure among sick hospitalized infants. AIDS. 2017 Jul 17;31(11):F1-F7. doi: 10.1097/QAD.0000000000001562.

    PubMed 28609404

  • Njuguna IN, Wagner AD, Cranmer LM, Otieno VO, Onyango JA, Chebet DJ, Okinyi HM, Benki-Nugent S, Maleche-Obimbo E, Slyker JA, John-Stewart GC, Wamalwa DC. Hospitalized Children Reveal Health Systems Gaps in the Mother-Child HIV Care Cascade in Kenya. AIDS Patient Care STDS. 2016 Mar;30(3):119-24. doi: 10.1089/apc.2015.0239.

    PubMed 27308805

Questions about this trial

What is this clinical trial studying?

A study testing Urgent ART and Early ART in people with Human Immunodeficiency Virus and Immune Reconstitution Inflammatory Syndrome, run by University of Washington at 4 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: 6 months post-HAART initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02063880, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.

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