IMPAACT P1073: Study of IRIS for Infants and Children Initiating HAART at Int'l Sites (NCT01240486) | Clinical Trial Compass
CompletedNot Applicable
IMPAACT P1073: Study of IRIS for Infants and Children Initiating HAART at Int'l Sites
India, South Africa, Tanzania207 participantsStarted 2010-11
Plain-language 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.
Who can participate
Age range4 Weeks – 72 Months
SexALL
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Inclusion criteria
✓. 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
✓. 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
✓. 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
Exclusion criteria
✕
What they're measuring
1
Proportion of study subjects having BCG-related IRIS within 48 weeks of initiating HAART.
Timeframe: within 48 weeks of iniating HAART
2
Proportion of study subjects having unmasking and paradoxical TB-related IRIS within 48 weeks of initiating HAART.
Timeframe: Within 48 weeks of initiating HAART
3
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.
Timeframe: At Study Entry, 2 weeks post-HAART and within 48 weeks of initiating HAART
4
CD4 T-cell count and percentage and plasma viral load, 48 weeks post-HAART initiation for CASES and the matching controls.
Timeframe: 48 weeks post-HAART
5
Frequency of all IRIS-like events and proportion attributed to BCG or TB.
Timeframe: within 48 weeks of initiating HAART
Trial details
NCT IDNCT01240486
SponsorInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group
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.