
History
The Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study was started in 2013 as the first large-scale study to assess clinical outcomes of people living with HIV (PLWH) over the age of 50 in England and Ireland.
Discussions around the management of HIV as a long-term chronic disease have been ongoing since the mid-1990s when the impressive benefits of antiretroviral therapy (ART) became apparent. Recent studies have suggested that PLWH may experience a speeding up of the aging process, with reports of increases in the rates of several co-morbidities, including cardiovascular disease (CVD), cancers, and end-stage liver and renal disease.
The cohort includes participants from 8 clinics, seven of which are in the UK, and one of which is in Ireland [link to clinical sites]. The cohort includes three specific groups of people:
- 699 PLWH aged >50 years;
- 374 PLWH aged <50 years; and
- 304 HIV-negative people aged >50 years.
The group of older PLWH were selected in such a way as to ensure that this older cohort is broadly representative of older PLWH in the UK and Ireland. The group of younger PLWH and the HIV-negative group were then selectively recruited to ensure that they had similar demographic and lifestyle characteristics to the older PLWH. This helps to ensure that our findings are as robust as possible.
It is hoped that findings from the study will be helpful for the development and implementation of evidence-based recommendations for the management and clinical monitoring of older PLWH. Study results will also contribute to the design of future studies for the treatment of diseases associated with ageing in this population.
Aims of study
Our overarching objectives are:
- to analyse the incidence and outcomes of co-morbidities in older PLWH and to describe the relationship of these co-morbidities 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; and
- to contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients.
Current research objectives:
The POPPY study aims to answer many research questions. As this is a cohort study, in which people are followed up over time, the questions that can be answered can evolve over time, as we identify gaps in our knowledge about the effects of aging in PLWH. Currently, the study investigators are undertaking research to address the following objectives:
- To describe the incidence, presenting features and outcomes of serious medical conditions in the subgroups of participants;
- To compare cognitive function in the three subgroups of participants, and to identify predictors of reduced cognitive function, overall and in each group;
- To compare the levels of chronic pain experienced by participants, to identify factors that are associated with more severe pain, and to describe the health-care resources that people who experience pain are using;
- To compare the frequency of mental health problems among older PLWH and to identify the factors that may be contributing to these problems, including social factors, HIV infection and its treatment, and co-morbidities;
- To investigate whether the concentrations of antiretroviral agents in plasma change as people get older;
- To describe the number of non-ART drugs that people are receiving in the cohort, and to describe the potential for unwanted drug-drug interactions between these drugs, as well as between these drugs and the treatments that people are receiving for their HIV;
- To determine whether there is a build-up of some drugs in the body which may then increase the risk of some side effects (for example, kidney problems).