Clinical trial NCT01237444 (phase 3, status: completed)
Conditions: hiv infection
ICD codes: Z21
Drugs: lopinavir/ritonavir plus one nucleoside, lopinavir /ritonavir plus two nucleosides
SMILES: OC(=O)[C@@H]1CCCN1, CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          1. > 18 years of age.

          2. Patient with documented HIV-1 infection

          3. Subject has voluntarily signed and dated an informed consent form

          4. Subject agrees not to take any medication during the study, including over the counter
             medicines or herbal preparations, without the approval of the trial physician.

          5. Documented HIV-1 RNA >1,000 copies/mL

          6. Subject naïve to ARV. (Patients who had received ARV ≤ 48 hours are allowed).

          7. Subject has indication to receive an antiretroviral regimen.

          8. Subjects can comply with protocol requirements.

          9. Subject's general medical condition, in the investigator's opinion, does not interfere
             with assessments and completion of the trial.

         10. If female, :

               1. use 2 different methods of birth control including, at least, one barrier method,
                  and are acceptable to both the subject and investigator, and

               2. has a urine pregnancy test performed at the Screening Visit and on Baseline.
                  Results of both tests must be negative.

               3. continue using 2 different methods of birth control including, at least, one
                  barrier method for at least 30 days after the end of the treatment period

        Exclusion Criteria:

          -  1. Evidence of viral resistance against lopinavir/ritonavir, and/or FTC or 3TC, and/or
             other nucleoside analogues based on the genotype resistance test performed at
             screening, considering resistance according to the panel IAS - USA, version in
             December, 2009.

             2. The presence of any of the following major mutations: V32I; I47V / A; L76V;
             V82A/F/T/S or the presence of two or more minor mutations at
             positions:10,20,24,33,46,50,53,54,63,71,73,84,90 is considered resistance to
             lopinavir/ritonavir.

             3. The presence of mutation M184V/I and/or K65R is considered resistance to 3TC or
             FTC. At the discretion of the investigator and based on the resistance test, a
             treatment based on lopinavir / ritonavir, plus 3TC or FTC and other similar nucleoside
             / nucleotide active could not be constructed.

             4. Previously documented HIV-2 infection. 5. Use of disallowed concomitant therapy 6.
             Patient has a current (active) diagnosis of acute hepatitis due to any cause OR
             chronic Hepatitis C WITH aspartate aminotransferase (AST) and/or alanine
             aminotransferase (ALT) >5 x upper limit of normal (ULN) AND/OR is likely to require
             treatment in the next year.

             7. Active Hepatitis B infection (regardless of stage of infection). 8. Any active
             clinically significant disease . 9. Subject has a currently active AIDS defining
             illness (Category C)30 days of screening. Subjects who are on stable maintenance
             therapy for an opportunistic infection may be enrolled.

             10. Life expectancy < 1 year according to the judgment of the investigator. 11.
             Screening laboratory analysis shows any of the following abnormal laboratory results:

             a. Hemoglobin < 8.0 g/dL b. Absolute neutrophil count < 750 cells/µL c. Platelet count
             < 50,000 mm3 d. Creatinine> 1.5 times the normal upper limit. 12. Subject enrolled in
             other clinical trials . 13. Use of any investigational agents within 30 days prior to
             screening. 14. Use of immunosuppressive drugs, cytokine inhibitors or other cytokines
             in the last year.

             15. Active substance use or abuse that the investigator determines may significantly
             interfere with study procedures 16. Any condition (including but not limited to
             alcohol and drug use) which in the opinion of the investigator, could compromise the
             subject's safety or adherence to the protocol.

             17. Subject is pregnant or breast-feeding.