Chronic Infection With HIV Clinical Trial
Official title:
A Pilot Randomized, Open Label Study to Evaluate Efficacy and Safety of the Combination of RAL+ATV/r in Comparison With TDF/FTC+ATV/r in HIV Infected Patients, Who Failed an Initial NNRTI Containing Regimen
The purpose of this pilot study is to assess the efficacy and safety of the combination of RAL+ATV/r in comparison with TDF/FTC+ATV/r in HIV-1 infected patients presenting virologic failure and PI and TDF naïve.
Overall Study Design and Plan: Description
This is a pilot, randomized, open-label study. All the participants will be assigned to
receive RAL+ATV/r or TDF/FTC+ATV/r. Patients will be evaluated at screening, randomization
(day 0), and on weeks 4, 8, 12, 24, 36 and 48.
At the screening visit, subjects must be willing and able to give written (signed and dated)
informed consent prior to any study specific procedures. They will receive a unique
screening number and will undergo the study procedures associated with the screening visit.
The investigator will evaluate whether the subject meets all eligibility criteria specified
and record the details of the informed consent process and the results of this assessment in
the subject's medical records. Two forms of the ICF will be signed, one for the subject and
the other to file at the site.
At baseline visit, enrollment criteria will be reviewed and subjects who meet all of them
will undergo study procedures. Subjects will receive instructions about study medications
and dosing schedule. Subjects should start study medication within 24 hours of the baseline
visit. Subjects will return to the investigator´s site for study visits and procedures.
Subjects who prematurely discontinue the study must return for a discontinuation visit and
undergo the study procedures identified for the discontinuation visit.
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