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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Hypertension

Keywords

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HIV blood pressure left ventricle metabolic profile treatment experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

candesartan 8-16 mg once daily

Group Type EXPERIMENTAL

candesartan

Intervention Type DRUG

tablet 8-16 mg once daily, one year

2

lercanidipine 10-20 mg once daily

Group Type ACTIVE_COMPARATOR

lercanidipine

Intervention Type DRUG

tablets 10-20 mg once daily, one year

Interventions

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candesartan

tablet 8-16 mg once daily, one year

Intervention Type DRUG

lercanidipine

tablets 10-20 mg once daily, one year

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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anna maria grandi, MD

Role: STUDY_CHAIR

University of Insubria, Varese, ITALY

paolo grossi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Insubria, Varese, Italy

andrea maria maresca, MD

Role: PRINCIPAL_INVESTIGATOR

University of Insubria, Varese, Italy

eleonora nicolini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Insubria, Varese, Italy

massimo giola, MD

Role: PRINCIPAL_INVESTIGATOR

University of Insubria, Varese, Italy

Locations

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University of Insubria, Department of Clinical Medicine

Varese, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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anna maria grandi, MD

Role: CONTACT

Phone: +39 0332 278403

Email: [email protected]

References

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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.

Reference Type BACKGROUND

PMID: 15903292 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12817187 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14627784 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12131567 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12872052 (View on PubMed)

Other Identifiers

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44758

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

candesartan

2

lercanidipine

Interventions

candesartan

lercanidipine

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Università degli Studi dell'Insubria

Principal Investigators

anna maria grandi, MD

paolo grossi, MD

andrea maria maresca, MD

eleonora nicolini, MD

massimo giola, MD

Locations

University of Insubria, Department of Clinical Medicine

Countries

Central Contacts

anna maria grandi, MD

References

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.

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.

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.

Other Identifiers

44758