Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients
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|ClinicalTrials.gov Identifier: NCT01066065|
Recruitment Status : Unknown
Verified February 2010 by Hospital Carlos III, Madrid.
Recruitment status was: Recruiting
First Posted : February 10, 2010
Last Update Posted : June 25, 2010
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 or disease|
|Cardiovascular Disease HIV Infections|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|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|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||January 2011|
Patients taking RAL 400 mg BID with Truvada
Patients taking Darunavir 800 mg QD plus Norvir 100 mg QD with truvada
- 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 ]
- Insulin resistance defined by HOMA index. [ Time Frame: baseline and week 12, 24, 36 and 48 ]
- Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs... [ Time Frame: baseline and week 12, 24, 36 and 48 ]
- Antiretroviral adherence and quality of life items. [ Time Frame: baseline and week 12,24,36,48 ]
- Efficacy defined as viral suppression and CD4 count recovery [ Time Frame: baseline and week 12,24,36,48 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066065
|Contact: Jose Medrano, MDfirstname.lastname@example.org|
|Hospital Carlos III||Recruiting|
|Madrid, Spain, 28029|