NCT02063880

Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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. 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. 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.

Detailed description

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

Conditions

• Human Immunodeficiency Virus
• Immune Reconstitution Inflammatory Syndrome

Interventions

Type	Name	Description
OTHER	Urgent ART	Children will be started on HAART \<48 hours after enrollment.
OTHER	Early ART	Children will be started on ART after stabilization 7-14 days after enrollment.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-02-17
• Last updated: 2018-05-14
• Results posted: 2017-07-25

Locations

4 sites across 1 country: Kenya

Regulatory

• FDA-regulated drug study