The Lung Impairment after TB-IRIS (LIFT-IRIS) Study: A

Longitudinal Evaluation of Immune Restoration and Lung

Function in HIV/TB

FOLLOW UP VISITTHATO MATUKANE

Study Objectives

• Primary Objectives• Objective 1: To find out whether ART initiation is associated with

increased pulmonary inflammation in HIV/pTB. • Objective 2: To test whether more rapid immune restoration on

ART is associated with impaired lung function in HIV/pTB.

• Secondary Objectives• Objective 1: To explore the relationship between ART initiation and

changes in lung structure and function. • Objective 2: To explore the association between host and pathogen

risk factors for lung injury, including nutritional factors and host and pathogen genetics.

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Patients with CD4 count <200 will be enrolled into a single prospective cohort, with all potential study subjects having a CD4 count <100 cells/mm3 offered entry into Aim 1 until that aim’s sample size (40 subjects) is reached.

Study setting

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•This visit should be done as close as possible to the date corresponding to 4 week after ART initiation, for AIM 1 participants the visit scan should be scheduled soon after this visit, the visit window for every visit is +/-5 days. The following procedures will be done on this visit:

VISIT 1 WEEK 4

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This test will be performed using the spirometer which will measure the person’s pulmonary function (ability to breath) by using FEV1/FVC (forced expiratory volume/forced volume capacity) as ratios. The spirometer has filter mouth pieces to prevent the spread of micro-organisms.

PFTs=Pulmonary function test

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CD4 count (if results from within 30 days are not available)HIV Viral loadClinical evaluations (vital signs, signs and symptoms etc)Collection of blood for PBMCs (peripheral blood mononuclear cells)

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This procedure is only performed on participants who have concerned for AIM 1. Its a radiation procedure it should be done 1-3 days prior to ART initiation and at week 4 after ART initiation, participants with a haemoglobin A1C that is greater than 6.5% will be excluded from this AIM.

FDG PET-CT

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CAT=Chronic Obstructive Pulmonary Disease Assessment Test. This questionnaire is designed to measure the impact of COPD in a person’s life.

CAT questionnaire

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The participant will be asked to walk for 6 minutes as fast as he can making up as many laps as possible. This test is used to measure exercise capacity.

6-minute walking test with O2 saturation

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• Only clinical evaluation will be done for this visit:• Vital signs• Physical examination• Medical history• Aes and SAEs• Symptom profile

Visit 2 (Week 8)

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The following procedures will be performed:• PFTs• Clinical evaluations• HIV viral load• 6-minute walking test• Collection of blood for PBMCs• CAT questionnaire

Visit 3 (Week 12)

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Only clinical evaluations will be done

Visit 4 (Week 16)

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Clinical evaluations

Visit 5 (Week 20)

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• PFTs• Clinical evaluations• 6-minute walking test with O2 saturation• CAT questionaire

Visit 6 (Week 24)

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Clinical evaluations

Visit 7 (Week 36)

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Visit 8 (Week 48)• PFTs• Clinical evaluations• 6-minutes walking test• CAT questionnaire

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Unscheduled visitIf a participant come to site for an unscheduled visit (a visit between scheduled visits but after the previous visit has been completed. A 97 visit should be added on the participant record and the AD001 visit contact form completed as to the reason for the visit.If a participant misses 3 visits is regarded as “lost to follow up” and an early withdrawal visit should be completed, only when the participant hasn’t had their week 48 visit. Efforts should be made to close up all open Aes, concomitant medications and other outstanding information.

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Possible challenges• Missing data• Over writing• Omitted information• GCP• Inconsistent data• Two ICF might be inconsistency in terms of language and

version• Database is still new a lot of errors could be done resulting in a

lot of queries• PFTs; participant may refuse to continue with the test. This

test is difficult.

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Thank You