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Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine

Primary Purpose

HIV Infections, Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
candesartan
lercanidipine
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, blood pressure, left ventricle, metabolic profile, treatment experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV infection
  • office blood pressure > 140/90 mmHg
  • no antihypertensive treatment
  • good quality echocardiogram

Exclusion Criteria:

  • cardiovascular diseases
  • hypothyroidism
  • diabetes
  • secondary hypertension
  • hepatic and renal failure

Sites / Locations

  • University of Insubria, Department of Clinical MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

candesartan 8-16 mg once daily

lercanidipine 10-20 mg once daily

Outcomes

Primary Outcome Measures

morpho-functional left ventricle characteristics
metabolic profile

Secondary Outcome Measures

systolic and diastolic blood pressure

Full Information

First Posted
November 26, 2007
Last Updated
December 5, 2007
Sponsor
Università degli Studi dell'Insubria
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1. Study Identification

Unique Protocol Identification Number
NCT00564057
Brief Title
Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine
Official Title
Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Human immunodeficiency virus infection and highly active antiretroviral therapy (HAART) are associated with an increased risk of cardiovascular disease: a wide range of alterations in lipid and glucose metabolism has been increasingly recognized in HIV patients treated with HAART. Few data are available on the effects of antihypertensive treatment on cardiac morpho-functional characteristics and metabolic parameters in HIV patients. Aim of the study is to assess the effects of chronic therapy with angiotensin receptor blocker(candesartan)or calcium channel blocker (lercanidipine)on metabolic profile and cardiac remodelling in HIV hypertensive patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hypertension
Keywords
HIV, blood pressure, left ventricle, metabolic profile, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
candesartan 8-16 mg once daily
Arm Title
2
Arm Type
Active Comparator
Arm Description
lercanidipine 10-20 mg once daily
Intervention Type
Drug
Intervention Name(s)
candesartan
Intervention Description
tablet 8-16 mg once daily, one year
Intervention Type
Drug
Intervention Name(s)
lercanidipine
Intervention Description
tablets 10-20 mg once daily, one year
Primary Outcome Measure Information:
Title
morpho-functional left ventricle characteristics
Time Frame
one year
Title
metabolic profile
Time Frame
one year
Secondary Outcome Measure Information:
Title
systolic and diastolic blood pressure
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV infection office blood pressure > 140/90 mmHg no antihypertensive treatment good quality echocardiogram Exclusion Criteria: cardiovascular diseases hypothyroidism diabetes secondary hypertension hepatic and renal failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
anna maria grandi, MD
Phone
+39 0332 278403
Email
amgrandi@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
anna maria grandi, MD
Organizational Affiliation
University of Insubria, Varese, ITALY
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
paolo grossi, MD
Organizational Affiliation
University of Insubria, Varese, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
andrea maria maresca, MD
Organizational Affiliation
University of Insubria, Varese, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
eleonora nicolini, MD
Organizational Affiliation
University of Insubria, Varese, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
massimo giola, MD
Organizational Affiliation
University of Insubria, Varese, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Insubria, Department of Clinical Medicine
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
15903292
Citation
Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. doi: 10.1016/j.amjmed.2005.01.047.
Results Reference
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PubMed Identifier
12817187
Citation
Gazzaruso C, Bruno R, Garzaniti A, Giordanetti S, Fratino P, Sacchi P, Filice G. Hypertension among HIV patients: prevalence and relationships to insulin resistance and metabolic syndrome. J Hypertens. 2003 Jul;21(7):1377-82. doi: 10.1097/01.hjh.0000059071.43904.dc.
Results Reference
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PubMed Identifier
14627784
Citation
Friis-Moller N, Sabin CA, Weber R, d'Arminio Monforte A, El-Sadr WM, Reiss P, Thiebaut R, Morfeldt L, De Wit S, Pradier C, Calvo G, Law MG, Kirk O, Phillips AN, Lundgren JD; Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med. 2003 Nov 20;349(21):1993-2003. doi: 10.1056/NEJMoa030218. Erratum In: N Engl J Med. 2004 Feb 26;350(9):955.
Results Reference
background
PubMed Identifier
12131567
Citation
Meng Q, Lima JA, Lai H, Vlahov D, Celentano DD, Strathdee S, Nelson KE, Tong W, Lai S. Use of HIV protease inhibitors is associated with left ventricular morphologic changes and diastolic dysfunction. J Acquir Immune Defic Syndr. 2002 Jul 1;30(3):306-10. doi: 10.1097/00126334-200207010-00006.
Results Reference
background
PubMed Identifier
12872052
Citation
Lindholm LH, Persson M, Alaupovic P, Carlberg B, Svensson A, Samuelsson O. Metabolic outcome during 1 year in newly detected hypertensives: results of the Antihypertensive Treatment and Lipid Profile in a North of Sweden Efficacy Evaluation (ALPINE study). J Hypertens. 2003 Aug;21(8):1563-74. doi: 10.1097/01.hjh.0000084723.53355.76.
Results Reference
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Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine

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