Text Size

Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Hospital Carlos III, Madrid.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier:
NCT01066065
First received: February 9, 2010
Last updated: June 24, 2010
Last verified: February 2010
History of Changes
  Purpose

The advent of new antiretroviral drugs improved the management of HIV naive patients in terms of efficacy. However, the long term metabolic profile of this drugs has not yet been compared and associations between new antiretrovirals and cardiovascular events remains controversial.

Moreover, the better tolerability and easy dosage of this new drugs might hypothetically influence adherence and QOL of HIV patients.


Condition
Cardiovascular Disease
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic Profile and Cardiovascular Biomarker Pattern Compared in naíve Patients Initiating HAART With TDF-FTC and Raltegravir 400mg BID Vs Darunavir 800 mg Plus Ritonavir 100 mg QD; a One Year Follow-up Observational Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Carlos III, Madrid:

Primary Outcome Measures:
  • lipid profile defined as a clinically significant increment (delta) in Total cholesterol LDL, HDL y non-LDL cholesterol. [ Time Frame: baseline and week 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Insulin resistance defined by HOMA index. [ Time Frame: baseline and week 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs... [ Time Frame: baseline and week 12, 24, 36 and 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antiretroviral adherence and quality of life items. [ Time Frame: baseline and week 12,24,36,48 ] [ Designated as safety issue: No ]
  • Efficacy defined as viral suppression and CD4 count recovery [ Time Frame: baseline and week 12,24,36,48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Raltegravir Cohort
Patients taking RAL 400 mg BID with Truvada
Darunavir Cohort
Patients taking Darunavir 800 mg QD plus Norvir 100 mg QD with truvada

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive naïve patients regularly attended at a referral outclinic. 1:1 Randomization in two arms by a local electronic process.

Criteria

Inclusion Criteria:

  • VIH-1

Exclusion Criteria:

  • pregnancy
  • previous Antiretroviral exposure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066065

Contacts
Contact: Jose Medrano, MD +34914532531 josemedranolaporte@hotmail.com

Locations
Spain
Hospital Carlos III Recruiting
Madrid, Spain, 28029
Sponsors and Collaborators
Hospital Carlos III, Madrid
  More Information

No publications provided

Responsible Party: Hospital Carlos III, Vicente Soriano
ClinicalTrials.gov Identifier: NCT01066065     History of Changes
Other Study ID Numbers: HCIII0110
Study First Received: February 9, 2010
Last Updated: June 24, 2010
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Carlos III, Madrid:
cardiovascular disease
HIV
metabolic disorder
HIV naive patients initiating HAART with Raltegravir or boosted Darunavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013