IRISNCT01240486
IMPAACT P1073: Study of IRIS for Infants and Children Initiating HAART at Int'l Sites
An observational study of IRIS and HIV, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 7 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 weeks to 72 months
- How many people
- 207 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Nov 2010to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 72 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
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- 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.
- HIV-infected infants and children who meet the ART guidelines of local programs or an IMPAACT or other protocol and who can be enrolled ≤ 1 week prior to starting HAART.
- No known active untreated opportunistic infection.
- Infants ≤ 12 months of age should have received BCG immunization and the date of BCG vaccine has to be known.
- Legal guardian able and willing to provide signed informed consent for participating in the IRIS study.
Who cannot join
- -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.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
South Africa3 sites
University of Stellenbosch, Tygerberg Hospital (8950)
Cape Town
Durban Pediatric HIV CRS (20201)
Durban, KwaZulu-Natal, 50202
Soweto IMPAACT CRS (8052)
Johannesburg, 2013
Tanzania1 site
Kilimanjaro Christian Medical CRS (12901)
IDC Research Offices, Moshi
About this study
Official title: 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
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.
Read the 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
- Keywords
- IRIS, HIV, Immune, Reconstitution, Inflammatory, Syndrome
- Medical subject headings
- Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study subjects having BCG-related IRIS within 48 weeks of initiating HAART.
Measured: within 48 weeks of iniating HAART
Proportion of study subjects having unmasking and paradoxical TB-related IRIS within 48 weeks of initiating HAART.
Measured: 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.
Measured: 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.
Measured: 48 weeks post-HAART
Frequency of all IRIS-like events and proportion attributed to BCG or TB.
Measured: within 48 weeks of initiating HAART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IRISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Mark Cotton, MD, Study chair, IMPAACT/Stellenbosch University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240486
- Sponsor's protocol ID
- IMPAACT P1073
- Other IDs
- U01AI068632
- Status last verified
- May 2014
- First submitted
- 11 Nov 2010
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01240486
- Acronym / sponsor ID
- IMPAACT P1073
- Keywords
- IRIS, HIV, Immune, Reconstitution, Inflammatory, Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 weeks to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (19 listed)
- 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.
- If Sample #1 is positive, collect and test Sample #2.
- If Sample #1 is positive, then collect and test 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.
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of study subjects having BCG-related IRIS within 48 weeks of initiating HAART.
Time frame: within 48 weeks of iniating HAART
Proportion of study subjects having unmasking and paradoxical TB-related IRIS within 48 weeks of initiating HAART.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks post-HAART
Frequency of all IRIS-like events and proportion attributed to BCG or TB.
Time frame: within 48 weeks of initiating HAART
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Cotton, MD study chair
IMPAACT/Stellenbosch University
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IRIS and HIV, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa, India, Tanzania, Uganda, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of study subjects having BCG-related IRIS within 48 weeks of initiating HAART. (time frame: within 48 weeks of iniating HAART). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.