POPPY Pharmacokinetic and clinical observations in people over fiftyA prospective, observational study to examine the effects of ageing on the clinical outcomes of people living with HIV in England and Ireland.

Phase 1

• Conditions: HIV; MedDRA version: 20.1Level: PTClassification code 10000807Term: Acute HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-003581-40-IE
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-07
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2000

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
•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
•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

The control groups will be frequency matched to the cases on gender, ethnicity, mode of HIV acquisition and clinic location.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified