A Prospective, Observational Study to Examine the Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty' (POPPY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Imperial College London
Sponsor:
Collaborators:
Gilead Sciences
Janssen, LP
ViiV Healthcare
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01737047
First received: November 1, 2012
Last updated: August 1, 2013
Last verified: April 2013

November 1, 2012
August 1, 2013
April 2013
May 2016   (final data collection date for primary outcome measure)
clinical manifestations of ageing [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
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. White or black african - analysis of demographic details and co-morbidity details collected at each visit.
clinical maniestations of ageing [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
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. White or black african - analysis of demographic details and co-morbity details collected at each visit.
Complete list of historical versions of study NCT01737047 on ClinicalTrials.gov Archive Site
  • variations of anti-retroviral medication associated with age. [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
    Comparison of two groups HIV+ve >50 and HIV+ <50 measurement of blood concentrations of HIV medications
  • to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities. [ Time Frame: two years ] [ Designated as safety issue: No ]
    Comparison of three groups HIV+ve >50, HIV+<50 and HIV-ve >50. Drug related side effects collected at each visit and also Co-morbidity details collected at each visit.
  • variations of anti-retroviral medication associated with age. [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
    Comparison of two groups HIV+ve >50 and HIV+ <50 measurement of blood concetrations of HIV medications
  • to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities. [ Time Frame: two years ] [ Designated as safety issue: No ]
    Comparison of three groups HIV+ve >50, HIV+<50 and HIV-ve >50. Drug realted side effects collected at each visit and also Co-morbity details collected at each visit.
To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients. [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
Comparison of co-morbidities in relation to age in the three groups: HIV+ve >50, HIV+ve <50 and HIV -ve >50.
To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients. [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
Comparison of co-morbidites in realtion to age in the threee groups: HIV+ve >50, HIV+ve <50 and HIV -ve >50.
 
A Prospective, Observational Study to Examine the Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty'
A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in England and Ireland

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 we monitor individuals with HIV infection. The results may also assist in the design of future studies for the treatment of diseases associated with ageing.

Multicentre, prospective, observational study over 3 years.

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

  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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood for storage Blood (serum and plasma,) and urine samples will be collected at visits 1 and 3 stored for subsequent projects of the potential pathogenic mechanisms underlying age-related diseases. This will include assessment of vitamin-D and PTH and probably DNA analysis.

Probability Sample

HIV positive over 50 years HIV positive between 18 and 50 years HIV negative over 50 years White Black african

  • HIV Positive
  • Ageing
Not Provided
  • 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

  • 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

  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
May 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Andrew Whitehouse, MB BS 00442075943413 a.whitehouse@imperial.ac.uk
Contact: Alan `Winston, MD 004420 3312 1603 a.winston@imperial.ac.uk
Ireland,   United Kingdom
 
NCT01737047
CRO: 1992, 2012-003581-40
Yes
Imperial College London
Imperial College London
  • Gilead Sciences
  • Janssen, LP
  • ViiV Healthcare
  • Bristol-Myers Squibb
  • Merck Sharp & Dohme Corp.
Study Director: Caroline Sabine, PhD University College, London
Study Director: Alan Winston, MD Imperial College London
Imperial College London
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP