HIV InfectionSSAT041NCT01286623
The Pharmacology/Aging Clinic
An observational study of HIV Infection, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial summary
The treatment of HIV and the tests performed for HIV care have changed over the last 20 years. However, improvement of management of HIV-infected subjects is still warranted, especially as the HIV-infected population is aging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2011to 6 Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV-infected patients over 50 years of age
Who may be able to join
- The ability to understand and sign a written informed consent form
- HIV-infected patients attending the Pharmacology/Aging Clinic (HIV/GUM Directorate, Chelsea and Westminster Hospital NHS Foundation Trust)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Title: The Pharmacology/Aging Clinic: Clinical Routine Monitoring of HIV-infected Patients Over 50 Year of Age.
The treatment of HIV and the tests performed for HIV care have changed over the last 20 years. However, improvement of management of HIV-infected subjects is still warranted, especially as the HIV-infected population is aging. Therefore, this study will involve the collection and analysis of clinical information obtained from subjects who are over 50 years of age. For example, patients' risk of heart disease will be measured and monitored by looking at blood tests and clinical data (such as blood pressure). This will allow researchers to understand if the current way of assessing the risk of future heart disease is the best one available for HIV-infected individuals. No genetic research will be done.
Read the detailed description
Patients will be asked to read the information contained in this leaflet. No extra visits will occur; all samples will be collected at their routine visits to the pharmacology clinic. All blood samples and results will be managed by the routine clinical laboratory at Chelsea and Westminster Hospital, with the exception of the assessment of the hsCRP. The latter is a marker of inflammation that is measured to be able to add more information when cardiovascular risk is assessed. The blood sample for this test is sent to a laboratory in London called The Doctors Laboratory (TDL). All shipped samples are anonymous and patient names will not be disclosed outside the Hospital.
The clinical visits will be scheduled approximately once within one year. However, extra visits may be clinically necessary if a clinical condition requires proper follow-up. Furthermore, clinical details will be marked to show patients have agreed to their use for this research study.
- Conditions
- HIV Infection
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study start1 Apr 2011
- Primary completion6 Jun 2013
- Study completion6 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Boffito, Dr, Principal investigator, St Stephen's AIDS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286623
- Sponsor's protocol ID
- SSAT 041
- Acronym
- SSAT041
- Status last verified
- Jun 2017
- First submitted
- 27 Jan 2011
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Title: The Pharmacology/Aging Clinic: Clinical Routine Monitoring of HIV-infected Patients Over 50 Year of Age.
- ClinicalTrials.gov ID
- NCT01286623
- Acronym / sponsor ID
- SSAT041 / SSAT 041
- Conditions
- HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 6 Jun 2013 (actual)
- Study completion
- 6 Jun 2013 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment of HIV and the tests performed for HIV care have changed over the last 20 years. However, improvement of management of HIV-infected subjects is still warranted, especially as the HIV-infected population is aging. Therefore, this study will involve the collection and analysis of clinical information obtained from subjects who are over 50 years of age. For example, patients' risk of heart disease will be measured and monitored by looking at blood tests and clinical data (such as blood pressure). This will allow researchers to understand if the current way of assessing the risk of future heart disease is the best one available for HIV-infected individuals. No genetic research will be done.
Detailed description
Patients will be asked to read the information contained in this leaflet. No extra visits will occur; all samples will be collected at their routine visits to the pharmacology clinic. All blood samples and results will be managed by the routine clinical laboratory at Chelsea and Westminster Hospital, with the exception of the assessment of the hsCRP. The latter is a marker of inflammation that is measured to be able to add more information when cardiovascular risk is assessed. The blood sample for this test is sent to a laboratory in London called The Doctors Laboratory (TDL). All shipped samples are anonymous and patient names will not be disclosed outside the Hospital.
The clinical visits will be scheduled approximately once within one year. However, extra visits may be clinically necessary if a clinical condition requires proper follow-up. Furthermore, clinical details will be marked to show patients have agreed to their use for this research study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-infected patients over 50 years of age
Key inclusion criteria (2 listed)
- The ability to understand and sign a written informed consent form
- HIV-infected patients attending the Pharmacology/Aging Clinic (HIV/GUM Directorate, Chelsea and Westminster Hospital NHS Foundation Trust)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Boffito, Dr principal investigator
St Stephen's AIDS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by St Stephens Aids Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.