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 range
4 Weeks – 72 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.