A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy
| Tracking Information | |||||
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| First Received Date ICMJE | August 18, 2005 | ||||
| Last Updated Date | April 25, 2007 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00131807 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy | ||||
| Official Title ICMJE | A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Allocation: Random Sample Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 3000 | ||||
| Completion Date | September 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00131807 | ||||
| Other Study ID Numbers ICMJE | NPSW03 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Imperial College London | ||||
| Collaborators ICMJE | The Hypertension Trust | ||||
| Investigators ICMJE |
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| Information Provided By | Imperial College London | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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