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Investigating chronic breathlessness in people living with HIV

What are the causes of chronic breathlessness in people living with and without HIV in the ART era? A pilot study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13866813
Enrollment
60
Registered
2018-11-23
Start date
2018-09-24
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathlessness in HIV positive and HIV negative participants Infections and Infestations Breathlessness in HIV positive and HIV negative participants

Interventions

Part 1 There will be an initial visit specifically for the study, in addition to routine clinical care. At this visit informed consent will be taken by a qualified study team member. A

Sponsors

Royal Free London NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: HIV positive participants: 1. HIV positive 2. Aged 18 years or older 3. Informed consent given 4. Chronic breathlessness (defined as MRC breathlessness score =2 persisting for at least 4 weeks and not due to an acute illness) 5. No definitive diagnosis to explain breathlessness (definitive diagnosis defined as patient or physician reported diagnosis substantiated by recent physiological investigations) 6. Able to participate for the duration of the study HIV negative participants: 1. Negative HIV test (performed as part of routine care) 2. Aged 18 years or older 3. Informed consent given 4. Chronic breathlessness (defined as MRC breathlessness score =2 persisting for at least 4 weeks and not due to an acute illness) 5. No definitive diagnosis to explain breathlessness (definitive diagnosis defined as patient or physician reported diagnosis substantiated by recent physiological investigations) 6. Able to participate for the duration of the study

Exclusion criteria

Exclusion criteria: All participants: 1. Unable to perform lung function tests. 2. Physical disability precluding the ability to complete a cardiopulmonary exercise test (for example wheelchair bound) 3. Pregnant 4. Unable to attend for investigations and review

Design outcomes

Primary

MeasureTime frame
Proportion of participants with breathlessness in HIV positive and HIV negative groups due to: 1. Cardiac disease 2. Respiratory disease 3. Psychological causes 4. Deconditioning 5. Other For each participant group, the causes of breathlessness will be reported as a proportion due to each of the causes above at the end of the study.

Secondary

MeasureTime frame
The following are assessed at the baseline and at the end of the study? 1. Prevalence of depression in HIV positive and negative groups as defined by Patient Health Questionnaire (PHQ-9) score =5, assessed using the PHQ-9 2. Prevalence of severe depression in HIV positive and negative groups as defined by PHQ-9 score =20, assessed using the PHQ-9 3. Prevalence of anxiety in HIV positive and negative groups as defined by Generalised Anxiety Disorder assessment (GAD-7) score =5, assessed using the GAD-7 4. Prevalence of severe anxiety in HIV positive and negative groups as defined by GAD-7 score =15, assessed using the GAD-7

Countries

United Kingdom

Contacts

Public ContactAmina Jaffer

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026