Clinical Trial: Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 randomiz

    Detailed Summary: Children will be followed and compared for 6-month mortality.
    Sponsor: University of Washington

    Current Primary Outcome: All-cause mortality [ Time Frame: 6 months post-HAART initiation ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Immune Reconstitution and Inflammatory Syndrome (IRIS) [ Time Frame: 6 months post-HAART initiation ]
    • Drug toxicity [ Time Frame: 6 months post-HAART initiation ]


    Original Secondary Outcome:

    • IRIS [ Time Frame: 6 months post-HAART initiation ]
    • Drug toxicity [ Time Frame: 6 months post-HAART initiation ]


    Information By: University of Washington

    Dates:
    Date Received: August 21, 2012
    Date Started: March 2013
    Date Completion:
    Last Updated: November 30, 2015
    Last Verified: November 2015