The purpose of this study is to evaluate the efficacy of raltegravir with optimized background therapy (OBT) in multiple-experienced HIV infected patients, measured by the proportion of patients with undetectable viral load and the mean increase of CD4 cells count at week 24 and 48. It is also intended to evaluate: * viral load suppression and the mean increase of CD4 cells count at week 24 and 48 in patients who needed to change antiretroviral (ARV) therapy due to inacceptable toxicity, as determined by the investigator, including patients who needed to replace T20. * efficacy of raltegravir with OBT in HIV-2 infected patients that were included in this cohort, measured by the percentage of patients with undetectable viral load and the mean change of CD4 cells count at week 24 and 48. Study hypotheses: * Raltegravir with OBT is effective in achieving and maintaining a long term virologic suppression along with a significant increase on CD4 cells count in both HIV-1 and HIV-2 infected patients. * Patients who replaced T20 by raltegravir, due to intolerance, are able to maintain long term virologic suppression.
Considering its novel mechanism of action, potency, safety and tolerability, and pharmacokinetic profile, raltegravir has been used in several clinical scenarios. Since its initial clinical use in multiresistant patients throughout the Expanded Access and Compassionate Use Program (started in March 2007) raltegravir has been used successfully in other clinical scenarios, including but not limited to: enfuvirtide-related serious adverse events and intolerance, nucleoside analogue inhibitors' toxicity, ritonavir and protease inhibitor intolerance and to avoid significant drug-drug interactions. Early access to raltegravir was basically focused on patients on therapeutic failure and triple-class resistance and due to enfuvirtide intolerance. In order to achieve a better understanding of the efficacy and safety profile of raltegravir in the clinical setting, it is intended to evaluate retrospectively HIV patients treated in Portugal with raltegravir since the Early Access and Compassionate Use Program (EAP) was implemented. This is a national, multicenter, observational, clinical cohort study with retrospective collection of data. Each site will include patients who had started treatment with raltegravir under the EAP.
Study Type
OBSERVATIONAL
Enrollment
151
HIV-RNA Levels
Patients with undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at baseline.
Time frame: Baseline
HIV-RNA Levels
Patients achieving undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at week 24.
Time frame: week 24
HIV-RNA Levels
Patients achieving undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at week 48.
Time frame: week 48
CD4 Cells Count
CD4 cells count at baseline.
Time frame: Baseline
CD4 Cells Count
CD4 cells count at week 24.
Time frame: week 24
CD4 Cells Count
CD4 cells count at week 48.
Time frame: week 48
HIV-RNA Levels
For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at baseline.
Time frame: Baseline
HIV-RNA Levels
For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at week 24.
Time frame: Week 24
HIV-RNA Levels
For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at week 48.
Time frame: Week 48
CD4 Cells Count
For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.
Time frame: Baseline
CD4 Cells Count
For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.
Time frame: Week 24
CD4 Cells Count
For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.
Time frame: Week 48
CD4 Cells Count
For the HIV-2 infected patients CD4 cells count will be assessed at baseline.
Time frame: Baseline
CD4 Cells Count
For the HIV-2 infected patients CD4 cells count will be assessed at week 24.
Time frame: Week 24
CD4 Cells Count
For the HIV-2 infected patients CD4 cells count will be assessed at week 48.
Time frame: Week 48
HIV-RNA Levels
For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at baseline.
Time frame: Baseline
HIV-RNA Levels
For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at week 24.
Time frame: Week 24
HIV-RNA Levels
For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA \< 50 copies/mL) at week 48.
Time frame: Week 48
Adverse Drug Reactions
Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.
Time frame: Week 48
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