Ageing, HIV Positive
Conditions
Keywords
HIV, Ageing
Brief summary
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.
Detailed description
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. 1. To analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors. 2. 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. 3. 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.
Interventions
None listed
Sponsors
Gilead Sciences
Janssen, LP
ViiV Healthcare
Bristol-Myers Squibb
Merck Sharp & Dohme LLC
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups | 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. |
Countries
Ireland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV Positive Over 50 Years of Age All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn | 699 |
| HIV Positive Under the Age of 50 All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.
Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn | 374 |
| HIV Negative Over the Age of 50 All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study. | 304 |
| Total | 1,377 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 10 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 17 | 11 | 4 |
Baseline characteristics
| Characteristic | HIV Positive Over 50 Years of Age | HIV Positive Under the Age of 50 | HIV Negative Over the Age of 50 | Total |
|---|---|---|---|---|
| Age, Continuous | 57 years | 43 years | 58 years | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 96 Participants | 75 Participants | 31 Participants | 202 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 603 Participants | 299 Participants | 273 Participants | 1175 Participants |
| Sex: Female, Male Female | 87 Participants | 72 Participants | 109 Participants | 268 Participants |
| Sex: Female, Male Male | 612 Participants | 302 Participants | 195 Participants | 1109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 699 | 0 / 379 | 0 / 304 |
| other Total, other adverse events | 0 / 699 | 0 / 379 | 0 / 304 |
| serious Total, serious adverse events | 0 / 699 | 0 / 379 | 0 / 304 |
Outcome results
Primary
The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups
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.
Time frame: after 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Positive Over 50 Years of Age (Median Age 57) | The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups | 473 participants |
| HIV Positive Under the Age of 50 (Median Age 43) | The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups | 224 participants |
| HIV Negative Over the Age of 50 (Median Age 58) | The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups | 188 participants |