POPPY Pharmacokinetic and clinical observations in people over fifty
Research type
Research Study
Full title
A prospective, observational study to examine the effects of ageing on the clinical outcomes of people living with HIV in England and Ireland.
IRAS ID
106078
Contact name
a winston
Eudract number
2012-003581-40
Clinicaltrials.gov Identifier
Research summary
Research Summary:
Our study will describe the impact of older age on the experience of living with HIV in England and Ireland. In particular, we are interested in documenting the medical conditions that cause particular problems to older individuals who are living with HIV, and the effect of these medical conditions (and any treatment received) on their lives and their HIV care. To do this, we will follow a large group of individuals over the age of 50 who are living with HIV. As control groups, we will also follow two additional groups: younger (<50 years) people living with HIV, and older (>50 years) people without HIV infection. The people living with HIV will be recruited from six clinics in the UK, and one in Ireland. All study participants will be followed over two years, with each person living with HIV being seen four times over that period: at screening, enrolment, 1 year and 2 years (the HIV-negative control group will also be seen at screening, enrolment and 2 years, but will be contacted by phone at the 1-year timepoint). At each visit, participants will undergo a clinical examination (including neurocognitive testing) and will be asked to complete questionnaires about their health, lifestyles and quality-of-life over the past year. A scan of bone density (DXA scan) will be performed at the first visit and again after 2 years. This would detect any signs of osteoporosis or bone thinning. Blood and urine samples will be stored for future analysis and, for those on HIV treatment, drug levels will be measured.
Summary of Results:
The total cohort includes 1377 participants.
1109 (80.5%) of the cohort were male (88.0%, 80.8% and 64.0% in the older PLWH (Patients Living with HIV), younger PLWH and HIV-negative controls, respectively).
963 (70.0%) define themselves as men who have sex with men (MSM) and 1175 (85.3%) have a white ethnic background.
The median age is 56 (53–62) for the older PLWH, 43 (37–47) for the younger PLWH and 58 (53–63) for the HIV-negative controls.
Almost 45% are single (54.0%, 31.0% and 15.0%, respectively).
Around two-thirds (64.7%) of participants are born to parents from the UK/Ireland.REC name
London - Fulham Research Ethics Committee
REC reference
12/LO/1409
Date of REC Opinion
28 Sep 2012
REC opinion
Further Information Favourable Opinion