NCT01240486

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

IMPAACT P1073: Study Of Immune Reconstitution Inflammatory Syndrome (IRIS) For International Sites Initiating Highly Active Antiretroviral Therapy (HAART) In Infants And Children < 72 Months Of Age

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 207 (actual)
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
• Sex: All
• Age: 4 Weeks – 72 Months
• Healthy volunteers: Not accepted

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 description

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

Conditions

• IRIS
• HIV

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-02-01
• Completion: 2013-10-01
• First posted: 2010-11-15
• Last updated: 2014-05-19

Locations

7 sites across 5 countries: India, South Africa, Tanzania, Uganda, Zimbabwe