Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
| Measure | Description | Time Frame |
|---|---|---|
| lipid profile defined as a clinically significant increment (delta) in Total cholesterol LDL, HDL y non-LDL cholesterol. | baseline and week 12, 24, 36 and 48 | |
| Insulin resistance defined by HOMA index. | baseline and week 12, 24, 36 and 48 | |
| Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs... | baseline and week 12, 24, 36 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Antiretroviral adherence and quality of life items. | baseline and week 12,24,36,48 | |
| Efficacy defined as viral suppression and CD4 count recovery | baseline and week 12,24,36,48 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Consecutive naïve patients regularly attended at a referral outclinic. 1:1 Randomization in two arms by a local electronic process.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Medrano, MD | Contact | +34914532531 | josemedranolaporte@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Carlos III | Recruiting | Madrid | 28029 | Spain |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D015658 | HIV Infections |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009750 | Nutritional and Metabolic Diseases |