None listed
Conditions
Interventions
THIS STUDY WILL BE A PERIOD OF 30 DAYS TO SELECTION, A PERIOD TREATMENT OF 48 WEEKS, FOLLOWED BY A PERIOD OF 4 WEEKS POST-TREATMENT FOLLOW (FU, FOLLOWRUP ENGLISH) (FIG. 1) WITH A VISIT FINAL WEEK MADE
Sponsors
Fundacion Huesped,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. ≥ 18 YEARS OLD. 2. DOCUMENTED HIV INFECTION-1 DEFINED BY POSITIVE ELISA PLUS CONFIRMATORY WESTERN BLOT;OR DOCUMENTED PLASMA HIV-RNA VIRAL LOAD ≥ 10,000 COPIES / ML. 3. THE PATIENT HAS VOLUNTARILY SIGNED AND DATED CONSENT FORM APPROVED BY THE COMMITTEE ON ETHICS, AFTER HAVE BEEN EXPLAINED THAT WHAT IS THE STUDY AND THE PATIENT HAS HAD A CHANCE TO ASK QUESTIONS. INFORMED CONSENT MUST BE SIGNED BEFORE ANY SPECIFIC STUDY PROCEDURE. 4. PATIENT AGREE TO DO NOT TAKE MEDICATION DURING THE STUDY, INCLUDING THOSE OVER THE COUNTER VITAMINS, MINERALS OR HERBS PREPARATIONS WITHOUT THE APPROVAL OF TRIAL PHYSICIAN. 5. VIRAL LOAD HIV-RNA> 1,000 COPIES / ML. 6. SUBJECT TREATMENT NAIVE ART (PERMITTED, PATIENTS WHO HAVE RECEIVED ARV 548 HOURS). 7. INDICATION THAT ARE SUBJECT ANTIRETROVIRAL. 8. SUBJECT THAT CAN MEET THE REQUIREMENTS OF THE PROTOCOL. 9. THE PATIENT GENERAL MEDICAL CONDITION, A JUDGMENT OF RESEARCH, NOT INTERFERE WITH OR ASSESSMENTS STUDY COMPLETION.
Exclusion criteria
Exclusion criteria: 1. EVIDENCE OF RESISTANCE LOPINAVIR / RITONAVIR, AND / OR FTC OR 3TC, AND / OR OTHER NUCLEOSIDE ANALOGUES BASED ON TEST RESULTS OF RESISTANCE TOUR MADE IN THE SELECTION PANEL CONSIDERING RESISTANCE BY THE-USA, DECEMBER 2009 VERSION. RESISTANCE IS CONSIDERED LOPINAVIR / RITONAVIR PRESENCE OF ANY OF THE FOLLOWING MAJOR MUTATIONS: V321; 147V / A, L76V; V82A/F/T/SO THE PRESENCE OF 2 OR MORE CHILDREN MUTATIONS IN POSITIONS 10, 20, 24, 33, 46, 50, 53, 54, 63, 71, 73, 84, 90. RESISTANCE IS CONSIDERED 3TC AND / OR THE PRESENCE FTC MUTATION K65R M184V/I Y/O K65R A CRITERION BASED RESEARCH AND TEST OF STRENGTH, CAN NOT BUILD A SYSTEM BASED LOPINAVIR / RITONAVIR, 3TC OR FTC MORE AND OTHER SIMILAR NUCLEOSIDE / NUCLEOTIDE ACTIVE. 2. INFECTION PRIOR HIV-2 DOCUMENTED. 3. MEDICATIONS USING INCIDENTAL NOT ALLOWED (SEE ANNEX H). 4. HAS PATIENT DIAGNOSIS OF ACUTE HEPATITIS ACTIVE FOR ANY CAUSE OR WITH CHRONIC HEPATITIS C ASPARTATE AMINOTRANSFERASE (AST) AND / OR ALANINE AMINOTRANSFERASE (AL N> 5 TIMES THE UPPER LIMIT OF NORMAL (ULN, BY THEIR ACRONYMS ENGLISH) AND / OR PROBABLY REQUIRE TREATMENT IN THE PERIOD OF ONE YEAR. 5. ACTIVE HEPATITIS B INFECTION (WHATEVER INFECTION STADIUM).
Countries
Argentina
Outcome results
None listed