HIV MedDRA version: 14.1 Level: PT Classification code 10000807 Term: Acute HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Viread
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tenofovir disoproxil fumarate
CAS Number: 202138-50-9
Current Sponsor code: CRO 1992
Concentration unit: mg milligram(s)
Sponsors
Imperial College, Research Governance Manager
Eligibility
Sex/Gender
All
Inclusion 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 • able to comprehend study patient information leaflet Younger HIV-positive cohort (n=500): • documented HIV infection • 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
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 |
|---|---|
| Main Objective: To analyse the incidence and outcomes of intercurrent illnesses (other illnesses occurring or recurring) in older HIV-positive people and their relationship with demographic( for example age, gender, ethnicity employment, housing and relationship status) and clinical factors (for example any details of past or present illnesses and treatments). Also history of illnesses within the family. ;Secondary Objective: To evaluate associations between antiretroviral drug concentrations and age, and to assess the potential impact of age on drug effectiveness, interactions or side effects becuse of drug combinations and other current illnesses. To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients. Our study, by enrolling both younger and older HIV-positive individuals matched with a HIV-negative control group, will be in the unique position to determine the effects of ageing and HIV status on chronic HIV-infection. In addition, results from this study will be well placed to assist in informing about future HIV treatment in older subjects and assisting in the design of future studies for the treatment of age associated illnesses in older HIV positive patients. It will also assess the use of healthcare resources and other medication in the older HIV positive group. ;Primary end point(s): Clinical events at baseline (prevalence) New clinical events or recurrence. Events considered will specifically include deterioration in neurocognitive function, bone pain, fractures, liver disease, kidney disease, myocardial infarction and malignancy. Other more general problems such as hypertension, changes in blood sugar levels, and cholesterol abnormalities will be addressed. Also it is hoped to be able to develop a measure of general frailty in an individual.;Timepoint(s) of evaluation of this end point: These will be visits at baseline, after 1 year and after 2 years. For HIV | — |
Countries
United Kingdom
Outcome results
None listed