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Status unknownNCT00564057Updated Dec 6, 2007

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

A Phase 4 interventional study of candesartan and lercanidipine in HIV Infections and Hypertension, sponsored by Università degli Studi dell'Insubria. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-12-06.

Sponsored by Università degli Studi dell'Insubria · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infections
  • Hypertension

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Keywords

  • HIV
  • blood pressure
  • left ventricle
  • metabolic profile
  • treatment experienced
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Università degli Studi dell'Insubria is the lead sponsor of 67 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

    candesartan 8-16 mg once daily

    Drug: candesartan

  • Active comparator
    2

    lercanidipine 10-20 mg once daily

    Drug: lercanidipine

Interventions

  • Drugcandesartan

    tablet 8-16 mg once daily, one year

  • Druglercanidipine

    tablets 10-20 mg once daily, one year

06

What researchers measure

Primary outcomes

  1. morpho-functional left ventricle characteristics

    Time frame: one year

  2. metabolic profile

    Time frame: one year

Secondary outcomes

  1. systolic and diastolic blood pressure

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • University of Insubria, Department of Clinical Medicine
    Varese, 21100, Italy
    Recruiting
08

References and documents

Publications

  • 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. PubMed 15903292 ↗
  • 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. PubMed 12817187 ↗
  • 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. PubMed 14627784 ↗
  • 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. PubMed 12131567 ↗
  • 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. PubMed 12872052 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00564057
Lead sponsor
Università degli Studi dell'Insubria
First posted
Nov 27, 2007
Start date
Sep 2007
Completion
Sep 2009 (estimated)
Last update
Dec 6, 2007

Study contacts

anna maria grandi, MD
Contact
amgrandi@libero.it
+39 0332 278403
anna maria grandi, MD
study chair · University of Insubria, Varese, ITALY
paolo grossi, MD
principal investigator · University of Insubria, Varese, Italy
andrea maria maresca, MD
principal investigator · University of Insubria, Varese, Italy
eleonora nicolini, MD
principal investigator · University of Insubria, Varese, Italy
massimo giola, MD
principal investigator · University of Insubria, Varese, Italy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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