E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Patients over the age of 50 with HIV infection |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000807 |
E.1.2 | Term | Acute HIV infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
|
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
These will be visits at baseline, after 1 year and after 2 years. For HIV negaive participants there will only be a telephone visit at year 1. Recruitment is likely to take 12 months. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To indicate the increased burden of treating concurrent disease in HIV +ve patients over 50 |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 28 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 28 |