Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects

Exclusion Criteria

• •1. Evidence of resistance to or 3TC or DRV/r, TDF, FTC o 3TC based in the results of the resistance testing done in the screening visit, such resistance being considered in accordance with IAS-USA panel, version dated March 2013.
• •Any of the following mutations will be considered resistance to DRV/r :
• •* I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V.
• •* Any of the following mutations will be considered resistance to 3TC or FTC : M184V/I and /or K65R and / or Q151M.
• •* Any of the following mutations will be considered resistance to TDF: K65R, K70E, double insertion 69 or 3 TAMS including M41L or L210W.
• •2. Prior HIV-2 documented infection.
• •3. The use of disallowed concomitant therapy (see Appendix C).
• •4. Active Hepatitis B infection (at any stage).
• •5. The patient was diagnosed with acute active hepatitis by any cause, or chronic hepatitis C WITH levels of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 5 higher than the upper limit of normal (ULN) AND/OR may require one-year treatment.
• •6. Any clinical significant active disease (for instance, tuberculosis, heart failure, pancreatitis) or any medical history or physical examination findings that, according to the investigator's opinion, may risk the patient's safety, the results of the study or adherence to the rules of the protocol.
• •7. The patient has an active AIDS-associated opportunistic disease (Category C according to the CDC classification system for HIV infection as of 1993) within 30 days after the screening. Stabilized patients under treatment for AIDS-associated opportunistic disease may be included in the study.
• •8. Life expectancy \< 1 year according to the investigator
• •9. Laboratory tests performed during the screening visit show any of the following alterations:
• •* Hemoglobin \<8.0 gm/dL
• •* Absolute neutrophil count (ANC) \< 750 cells/µL
• •* Platelet Count \< 50,000 cells/mm3
• •10. The use of any study agent within 30 days as from the screening.
• •11. Use of immunosuppressive drugs, cytokines inhibitors or other cytokines over the prior year.
• •12. Any other condition (including, without limitation, the use of alcohol or drugs) that in the investigator's opinion may compromise the safety of the patient or his/her adherence to the protocol
• •13. Patients who are pregnant or breastfeeding