HIV InfectionsNCT00131807
A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy
An observational study of HIV Infections, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to explore the association between blood pressure, HIV and/or its treatment in a cross sectional observational study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Blood Pressure Measurement and Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2005to Sep 2006
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Attending St. Mary's sexual health outpatient department
- Patients willing to give written informed consent
- Ability to communicate in English
Who cannot join
- Failure to give written informed consent in English
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the association between blood pressure, HIV and/or its treatment in a cross sectional observational study.
Read the detailed description
Deaths from AIDS have declined dramatically since the introduction of highly active antiretroviral therapy in HIV infected patients. However the incidence of heart disease has increased four-fold and is now one of the major causes of death in HIV infected patients. While HIV drugs are known to adversely affect serum lipids, the evidence concerning the association between raised blood pressure (a major risk for cardiovascular disease) HIV and/or its treatment is limited and conflicting. The researchers believe it of interest to study heart disease risk factors in patients with HIV infection to avoid one premature cause of death (AIDS) being replaced with another potentially preventable cause of death and disability (heart disease). In this cross sectional observational study the researchers will systematically measure blood pressure and other cardiovascular risk factors in HIV positive patients on and off antiretroviral therapy. These individuals will be matched for age, sex and ethnic group with HIV negative individuals.
- Conditions
- HIV Infections
- Being tested
- Blood Pressure Measurement, Questionnaire
- Keywords
- Blood Pressure, HIV, Antiretroviral therapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure MeasurementProcedure or surgery
QuestionnaireProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startSep 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 3,000 participants
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- The Hypertension Trust
- Investigators
- Neil R Poulter, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131807
- Sponsor's protocol ID
- NPSW03
- Status last verified
- Apr 2007
- First submitted
- 18 Aug 2005
- Last updated
- 28 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00131807
- Acronym / sponsor ID
- NPSW03
- Conditions
- HIV Infections
- Keywords
- Blood Pressure, HIV, Antiretroviral therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- The Hypertension Trust
- Study start
- Sep 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Aug 2005 (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 purpose of this study is to explore the association between blood pressure, HIV and/or its treatment in a cross sectional observational study.
Detailed description
Deaths from AIDS have declined dramatically since the introduction of highly active antiretroviral therapy in HIV infected patients. However the incidence of heart disease has increased four-fold and is now one of the major causes of death in HIV infected patients. While HIV drugs are known to adversely affect serum lipids, the evidence concerning the association between raised blood pressure (a major risk for cardiovascular disease) HIV and/or its treatment is limited and conflicting. The researchers believe it of interest to study heart disease risk factors in patients with HIV infection to avoid one premature cause of death (AIDS) being replaced with another potentially preventable cause of death and disability (heart disease). In this cross sectional observational study the researchers will systematically measure blood pressure and other cardiovascular risk factors in HIV positive patients on and off antiretroviral therapy. These individuals will be matched for age, sex and ethnic group with HIV negative individuals.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Attending St. Mary's sexual health outpatient department
- Patients willing to give written informed consent
- Ability to communicate in English
Key exclusion criteria (1 listed)
- Failure to give written informed consent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Pressure Measurement | Procedure or surgery | – |
| Questionnaire | Procedure or surgery | – |
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 28 May 2015.
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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.
Neil R Poulter principal investigator
Imperial College London
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 Infections, run by Imperial College London 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 3 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 28 May 2015. 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 28 May 2015.