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

Completed

• Conditions: IRIS; HIV

• Registration Number: NCT01240486
• Lead Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

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 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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-11
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Primary Completion: 2013-02
• Study Completion: 2013-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of study subjects having BCG-related IRIS within 48 weeks of initiating HAART.	within 48 weeks of iniating HAART
Proportion of study subjects having unmasking and paradoxical TB-related IRIS within 48 weeks of initiating HAART.	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.	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.	48 weeks post-HAART
Frequency of all IRIS-like events and proportion attributed to BCG or TB.	within 48 weeks of initiating HAART

Trial Locations

Locations (7)

Durban Pediatric HIV CRS (20201); 🇿🇦 Durban, KwaZulu-Natal, South Africa

BJ Medical College CRS (31441); 🇮🇳 Pune, Maharashtra, India

Kilimanjaro Christian Medical CRS (12901); 🇹🇿 IDC Research Offices, Moshi, Tanzania

University of Stellenbosch, Tygerberg Hospital (8950); 🇿🇦 Cape Town, South Africa

Makerere University - JHU Research Collaboration (30293); 🇺🇬 Kampala, Uganda

Soweto IMPAACT CRS (8052); 🇿🇦 Johannesburg, South Africa

UZ-Parirenyatwa CRS (30313); 🇿🇼 Harare, Zimbabwe