Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients

Study Overview
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Brief Summary
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This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol levels. Randomization will be stratified according to the values of the ratio of total cholesterol/HDL cholesterol obtained during the screening visit (as they will be <4.5 or ≥ 4.5).

Conditions
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HIV-1

Intervention / Treatment
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* Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine
* Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes aged 18 years or more. Women of childbearing potential must commit to sexual abstinence or use barrier contraceptive methods during the study. Diagnosis of infection by HIV-1 (according to standard diagnostic criteria) Not previously treated with antiretroviral drugs Plasma viral load > = 1000 copies / ml Clinically stable patients in the investigator's opinion at the time of inclusion Able to meet the schedule of study visits and other protocol requirements Written informed consent to participate in the study and undergo tests and examinations that entails Exclusion Criteria: ALT, AST levels greater than or equal to 5 times ULN (upper limit of normal) serum creatinine level greater than 2 times ULN Diabetes Mellitus (according to clinical and / or use of anti-diabetic agents) Obesity (BMI ≥ 30 kg/m2) Use of drugs that may affect lipid and / or glucose metabolism for at least 30 days prior to inclusion in the study. Active opportunistic infection requiring intravenous treatment Patients with known hypersensitivity to any of the products under study Use of drugs formally contraindicated in the product information for any of the drugs under study Contraindication to the use of any of the drugs under study Women pregnant or lactating at the time of study inclusion or anticipating pregnancy in the follow-up period provided by the test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darunavir / Ritonavir<br> | Drug: Darunavir / Ritonavir + Tenofovir / Emtricitabine<br>* oral, 800/100 mg, qd + oral, 300/200 mg, qd<br>|
| Experimental: Atazanavir / Ritonavir<br> | Drug: Atazanavir / Ritonavir + Tenofovir / Emtricitabine<br>* oral, 300/100 mg, qd + oral, 300/200 mg, qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total cholesterol |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol |  | 24, 48 and 96 weeks | 
| Cardiovascular risk according to the Framingham scale. |  | 24, 48 and 96 weeks. | 
| Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index)) |  | 24, 48 and 96 weeks | 
| inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin) |  | 24, 48 and 96 weeks | 
| RNA viral load <50 copies / mL |  | 24, 48 and 96 weeks. | 
| CD4+ cells count |  | 24, 48 and 96 weeks | 
| clinical adverse events, including events related to depositional patterns, laboratory abnormalities and incidence of treatment discontinuation because of toxicity or intolerance in each of the treatment arms. |  | 24, 48 and 96 weeks | 
| distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan |  | 48 and 96 weeks |