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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

February 9, 2010
June 24, 2010
February 2010
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01066065 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients
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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Consecutive naïve patients regularly attended at a referral outclinic. 1:1 Randomization in two arms by a local electronic process.
  • Cardiovascular Disease
  • HIV Infections
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • VIH-1

Exclusion Criteria:

  • pregnancy
  • previous Antiretroviral exposure
Both
18 Years and older
No
Contact: Jose Medrano, MD +34914532531 josemedranolaporte@hotmail.com
Spain
 
NCT01066065
HCIII0110
No
Hospital Carlos III, Vicente Soriano
Hospital Carlos III, Madrid
Not Provided
Not Provided
Hospital Carlos III, Madrid
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP