Clinical Trial: IMPAACT P1073: Study of IRIS for Infants and Children Initiating HAART at Int'l Sites

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: IMPAACT P1073: Study Of Immune Reconstitution Inflammatory Syndrome (IRIS) For International Sites Initiating Highly Active Antiretroviral Therapy (HAART) In Infants And C

Brief Summary: Your child is able to participate in this study, if your child's doctor is planning to start your child on HAART (which is a combination of at least 3 anti HIV drugs). When your child is treated with HAART, the way your child's body is able to fight infection may change. The immune system is the body's defense against infection. Your child's immune system may respond in a stronger way to some types of infections that your child may already have. This immune response may cause your child to become sick and the condition is then called "immune reconstitution inflammatory syndrome" or IRIS.

Detailed Summary:

IMPAACT P1073 is a prospective clinical, observational and pathogenesis study of HIV-infected infants and children who are ART-naïve and will be initiating a HAART regimen at an IMPAACT study site. Where possible, infants and children co-enrolled in IMPAACT studies will be given preference for enrollment in P1073.

The plan is to enroll subjects in P1073 at a timepoint ≤ 1 week prior to starting HAART. For DMC purposes, this is Step 1 for P1073, and subjects are designated as a Non-case, according to the Study Flow Chart


Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Current Primary Outcome:

  • Proportion of study subjects having BCG-related IRIS within 48 weeks of initiating HAART. [ Time Frame: within 48 weeks of iniating HAART ]
  • Proportion of study subjects having unmasking and paradoxical TB-related IRIS within 48 weeks of initiating HAART. [ Time Frame: Within 48 weeks of initiating HAART ]
  • Nadir CD4 T-cell count and percentage and plasma viral load pre-HAART initiation, and two weeks post-HAART and CD4 T-cell count and percentage and plasma viral load at the presumptive BCG or TB-IRIS event, for CASES and the matching controls. [ Time Frame: At Study Entry, 2 weeks post-HAART and within 48 weeks of initiating HAART ]
  • CD4 T-cell count and percentage and plasma viral load, 48 weeks post-HAART initiation for CASES and the matching controls. [ Time Frame: 48 weeks post-HAART ]
  • Frequency of all IRIS-like events and proportion attributed to BCG or TB. [ Time Frame: within 48 weeks of initiating HAART ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Dates:
Date Received: November 11, 2010
Date Started: November 2010
Date Completion:
Last Updated: May 16, 2014
Last Verified: May 2014