The Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty'

The purpose of this study is to identify medical conditions that may cause particular problems to individuals receiving care for HIV infection over the age of 50. In addition, as the effects and potentially the side effects, of HIV medication may change with age, this study will also investigate the association between age and differing effects of antiretroviral therapies such as treatment outcomes, side effects and the levels of drugs in blood.

Results from this study may inform future HIV treatment guidelines on how individuals with HIV infection are monitored. The results may also assist in the design of future studies for the treatment of diseases associated with ageing.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Positive Ageing Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital, Dublin, Ireland

About this study

Multicentre, prospective, observational study over 3 years.

The study will describe the impact of advancing age on the experience of living with HIV in England and Ireland. To address this cohorts of HIV-positive people aged >50 and <50 years (as well as demographically matched HIV-negative people aged >50 years) will be established.

To analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors.
To evaluate associations between antiretroviral drug concentrations and age, and to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities.
To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients.

2000 will be recruited in all either white or black african individuals (self reported) 1000 will be Over 50 years of age and HIV positive, 500 will be under the age of 50 and will be HIV positive and 500 will be over the age of 50 and be HIV negative.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Older HIV-positive cohort (n=1000):

documented HIV infection
age >50 years at study entry
self defined white or black African ethnicity
likely route of HIV acquisition via sexual exposure Either by male to male exposure if white or by heterosexual exposure if white or black African
able to comprehend study patient information leaflet

-Younger HIV-positive cohort (n=500):

documented HIV infection
age <50 at study entry*
self defined white or black African ethnicity
likely route of HIV acquisition via sexual exposure Either by male to male exposure if white or by heterosexual exposure if white or black African.
able to comprehend study patient information leaflet

this group will comprise of at least 150 subjects in each of the following age groups: 20-29, 30-39, 40-49 years. Recruitment will be monitored by the Study Monitoring Team.

HIV-negative cohort (n=500):

documented negative HIV test at screening
age >50 years at study entry
self defined white or black African ethnicity
registered with a General Practitioner and gives permission for contact with that General Practitioner.

Exclusion criteria

in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
life expectancy less than 6 months

Treatment and study plan

Primary outcomes

The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups

Time frame: after 1 year

The number of patients reporting aches and pains in the 3 arms were used to analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors.Comparison of three groups HIV+ve >50, HIV+<50 and HIV-ve >50.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

Bristol-Myers Squibb
Gilead Sciences
Janssen, LP
Merck Sharp & Dohme LLC
ViiV Healthcare

Registry information

Official study title

A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in England and Ireland

Acronym: POPPY

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2023
First posted: Nov 29, 2012
Registry last updated: Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed