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

NCT01240486 | Completed

• 2 other identifiers: IMPAACT P1073U01AI068632
• Study Type: observational
• Target: 207
• Locations: 5 countries
• Sites: 7

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.

Conditions

IRIS; HIV

Keywords

IRIS; HIV; Immune; Reconstitution; Inflammatory; Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 4 Weeks - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This is a prospective, clinical observational and pathogenesis study of HIV-infected infants and children stratified into 2 age groups: ≥ 4 weeks to ≤ 12 months of age; and \> 12 to \< 72 months of age who will enroll into P1073 at a timepoint ≤ 1 week prior to initiating HAART

You may qualify if:

• Past or current documentation of a confirmed diagnosis of HIV-1 infection. Documentation of HIV-1 infection is defined as positive results from two samples collected at different time points. All samples tested must be whole blood, serum, or plasma.
• Sample #1 may be tested by non-study public or PEPFAR programs. However, both the result and the assay date must be recorded in subject's chart. Source documentation (patient's medical record/chart, Ministry of Health (MOH) registers, laboratory results, etc.) must be available if requested.
• Sample #2 must be performed in a CAP/CLIA-approved laboratory (for US sites) or in a laboratory that operates according to GCLP guidelines and participates in an appropriate external quality assurance program (for international sites).
• For P1073, the subject may be enrolled before the result of Sample #2 is available. However, the subject will be taken off study should the 2nd result be negative.
• Acceptable tests when subjects are ≤ 18 months of age
• Sample #1 may be tested using any of the following: One HIV DNA PCR; One quantitative HIV RNA PCR (\>5,000 copies/mL); One qualitative HIV RNA PCR; One total HIV nucleic acid test
• \*\*If Sample #1 is positive, collect and test Sample #2.
• Sample #2 may be tested using any of the assays listed above for Sample #1.
• Acceptable tests when subjects are \> 18 months of age
• Sample #1 may be tested using any of the following: Two rapid antibody tests from different manufacturers or based on different principles and epitopes; One EIA OR Western Blot OR immunofluorescence OR chemiluminescence; One HIV DNA PCR; One quantitative HIV RNA PCR (\>5,000 copies/mL; One qualitative HIV RNA PCR; One HIV culture (prior to August 2009); One total HIV nucleic acid test
• \*\*If Sample #1 is positive, then collect and test Sample #2.
• Sample #2 may be tested using any of the following: One EIA confirmed by Western Blot OR immunofluorescence OR chemiluminescence; One HIV DNA PCR; One quantitative HIV RNA PCR (\>5,000 copies/mL); One qualitative HIV RNA PCR; One HIV culture (prior to August 2009;)One total HIV nucleic acid test
• Rapid antibody tests are not allowed for sample #2
• Age: range is ≥ 4 weeks to \< 72 months of age at time of HAART initiation.
• \*All infants and children ≥ 4 weeks to \< 72 months of age, who are about to initiate HAART according to National or WHO criteria, are eligible.

You may not qualify if:

• Any clinically significant diseases (other than HIV infection) e.g. malignancy, auto-immune or inflammatory diseases requiring long-term immunosuppressive therapy, or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study. Please contact the team at actg.teamp1073@fstrf.org.

Sponsors & Collaborators

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (7)

BJ Medical College CRS (31441)

Pune, Maharashtra, 411001, India

Location

Durban Pediatric HIV CRS (20201)

Durban, KwaZulu-Natal, 50202, South Africa

Location

University of Stellenbosch, Tygerberg Hospital (8950)

Cape Town, South Africa

Location

Soweto IMPAACT CRS (8052)

Johannesburg, 2013, South Africa

Location

Kilimanjaro Christian Medical CRS (12901)

IDC Research Offices, Moshi, Tanzania

Location

Makerere University - JHU Research Collaboration (30293)

Kampala, Uganda

Location

UZ-Parirenyatwa CRS (30313)

Harare, Zimbabwe

Location

MeSH Terms

Conditions

Syndrome

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Cotton, MD

  IMPAACT/Stellenbosch University

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 19, 2014

Record last verified: 2014-05

Locations

UG (1); TA (1); ZA (3); ZI (1); IN (1)