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

This study is ongoing, but not recruiting participants.
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: February 19, 2016
Last verified: October 2015
  Purpose

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.


Condition
HIV Positive
Ageing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in England and Ireland

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
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.

Enrollment: 1374
Study Start Date: April 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
HIV positive over 50 years HIV positive between 18 and 50 years HIV negative over 50 years White Black african
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737047

Locations
Ireland
University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital
Dublin, Ireland, 7
United Kingdom
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom, BN2 5BE
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR
Royal Free Hospital
London, United Kingdom, NW3 2QG
Kings College Hospital NHS Trust
London, United Kingdom, SE5 9RJ
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
St Marys Hospital NHS Trust
London, United Kingdom, W2 1NY
University College NHS Trust
London, United Kingdom, WC1E 6JB
Sponsors and Collaborators
Imperial College London
Gilead Sciences
Janssen, LP
ViiV Healthcare
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Investigators
Study Director: Caroline Sabine, PhD University College, London
Study Director: Alan Winston, MD Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01737047     History of Changes
Other Study ID Numbers: CRO: 1992  2012-003581-40 
Study First Received: November 1, 2012
Last Updated: February 19, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
HIV
Ageing

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 05, 2016