Human Immunodeficiency Virus Clinical Trial
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.
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.
Children will be followed and compared for 6-month mortality. ;
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