Condition category
Respiratory
Date applied
21/04/2017
Date assigned
27/04/2017
Last edited
10/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The human immunodeficiency virus (HIV) is a type of virus known as a retrovirus. HIV attacks and weakens the immune system, making it more difficult for a sufferer to fight infections. It is a highly contagious disease, through bodily fluids such as blood, semen and vaginal fluids. There is currently no cure for HIV, but there are a range of drug treatments (antiretroviral therapy) that can help people who are HIV positive to lead a long and full life. HIV infection is associated with a high rate of respiratory (breathing) disease despite the use of antiretroviral therapy. As the HIV positive population in the UK ages, long-term lung diseases such as COPD will become increasingly important. A better understanding of the causes of respiratory illness in this population is therefore needed to help find ways to reduce the impact of disease. The aim of this study is to look at the frequency of acute respiratory illness (a sudden illness that affects breathing) in those with HIV who have access to antiretroviral therapy compared to people without HIV.

Who can participate?
Adults who are HIV positive and those who are HIV negative.

What does the study involve?
All participants are followed for a period of 12 months. During this time they are asked to complete weekly diaries to assess the development of any acute respiratory illness. When such illnesses occur, participants are asked to attend for review - at these times the severity and duration of these acute respiratory illnesses are measured using breathing tests, blood tests, and questionnaires. In addition, samples are taken from the nose and throat using nasal swabs and lungs which are analysed to find out what has caused the condition in the laboratory.

What are the possible benefits and risks of participating?
Participants benefit from receiving the results of their lung function tests, which can also be passed onto their GP. This could help their future care. During the study participants are asked to contact one of the research team if they get any new respiratory symptoms such as coughing, blocked or runny nose, breathlessness or chest pain. If this happens the researchers will then arrange to see the participants again and to take samples. If any micro-organisms that are causing infection are identified at these times then this might help with treatment. There are no significant risks anticipated. The swabs taken from participant's noses and throats and blood testing may cause mild discomfort. In a few cases collecting samples from the chest may cause wheezing.

Where is the study run from?
Royal Free Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2014 to February 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr James Brown
james.brown.14@ucl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr James Brown

ORCID ID

http://orcid.org/0000-0002-2820-5847

Contact details

Department of Respiratory Medicine
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
+44 20 7794 0500 extension 34304
james.brown.14@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RFL9065

Study information

Scientific title

Acute respiratory tract illness in an HIV infected population with a high uptake of antiretroviral therapy

Acronym

Study hypothesis

Research questin:
Do HIV positive individuals have a higher frequency of acute respiratory illness in a setting with good access to effective antiretroviral therapy?

Ethics approval

NRES Committee London - Hampstead, 15/09/2014, ref: 14/LO/1409

Study design

Prospective observational epidemiological study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

See additional files

Condition

Acute respiratory illness

Intervention

All participants will have baseline tests and then be asked to report the frequency of acute respiratory illness over a 12 month period. When participants develop an acute respiratory illness, they will be asked to complete a diary recording the severity and duration of this illness and attend to have samples taken for microbiological analysis.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The annual incidence of acute respiratory illness in HIV positive compared to HIV negative participants is measured over 12 months of follow-up with weekly contacts to participants.

Secondary outcome measures

1. Duration of symptoms during respiratory tract illness in HIV infected and uninfected participants is measured by participant diaries completed daily during acute respiratory illness
2. Health-related quality of life measured by the St Georges Respiratory Questionnaire and EuroQoL-5D at baseline
3. Healthcare resource utilisation arising from acute respiratory illness during acute respiratory tract illness measured using participant daily diaries
4. The prevalence of positive microbial isolation in throat swabs and sputum samples at baseline
5. The prevalence of positive microbial isolation during acute respiratory illness in throat swabs and sputum samples
6. The baseline prevalence of obstructive lung disease is measured by pre-bronchodilator spirometry at baseline

Overall trial start date

15/09/2014

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

HIV-infected cohort:
1. HIV positive
2. Willing to participate in study and able to return for review in the event of respiratory tract infections, and to participate for the duration of the study
3. 18 years or above

HIV-uninfected participants:
1. Willing to participate in study and able to return for review in the event of respiratory tract infections, and to participate for the duration of the study
2. 18 years or above
3. Consent to HIV testing
4. Negative HIV test

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. Unable to participate for the full duration of the study
2. Unable to return for review in the event of respiratory tract infection (for instance those living a long distance from the study site)
3. Current significant acute respiratory tract illness such as pulmonary tuberculosis, Pneumocystis jirovecii pneumonia

Recruitment start date

01/12/2015

Recruitment end date

01/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in an open-access peer reviewed journal within 12 months of study completion.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to existing research ethics permissions regarding data storage.

Intention to publish date

01/02/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

10/08/2017: Internal review.