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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Eurotrials Brasil Consultores Cientificos Ltda | INDUSTRY |
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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:
Study hypotheses:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CohortHIV | Adult multiple-experienced HIV infected patients who needed to change their antiretroviral therapy and initiated raltegravir + optimized background therapy under the Early Access Program. |
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| Measure | Description | Time Frame |
|---|---|---|
| HIV-RNA Levels | Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline. | Baseline |
| HIV-RNA Levels | Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24. | week 24 |
| HIV-RNA Levels | Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48. | week 48 |
| CD4 Cells Count | CD4 cells count at baseline. | Baseline |
| CD4 Cells Count | CD4 cells count at week 24. | week 24 |
| CD4 Cells Count | CD4 cells count at week 48. | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| HIV-RNA Levels |
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Inclusion Criteria:
Male or female patients, aged 18 years or older
ARV multi-experienced patients (i.e. experienced at least two prior regimens) with need to change current ARV therapy, including:
Raltegravir-naïve patients who initiated raltegravir since the EAP Program, with optimized background therapy(OBT)
Patient who has been followed at the same clinical site since the start of raltegravir
Exclusion Criteria:
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HIV-infected adult portuguese patients who started treatment with raltegravir since the Early Access Program and Compassionate Use Program (from March 2007 to December 2008)
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| Name | Affiliation | Role |
|---|---|---|
| Manuela S Doroana, MD | Hospital de Santa Maria - Centro Hospitalar Lisboa Norte | Principal Investigator |
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197 patients were included in the database. However, only 151 patients were included in the analysis, as 46 did not meet inclusion/exclusion criteria
Retrospective collection of data took place in 11 portuguese public hospitals. Each site included patients who started treatment with raltegravir from March 2007 until December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV-1 at Virologic Failure | Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL) |
| FG001 | HIV With Need for Therapy Change | Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20) |
| FG002 | HIV-2 With Therapeutic Failure | Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV-1 at Virologic Failure | Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL) |
| BG001 | HIV With Need for Therapy Change |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HIV-RNA Levels | Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline. | Posted | Number | participants | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV-1 at Virologic Failure | Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema of the lower extremities | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doroana, Maria Manuela, M.D. | Hospital de Santa Maria - Centro Hospitalar Lisboa Norte | 351 217938043 | manuela.doroana@hsm.min-saude.pt |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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.
| 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. | Week 48 |
| CD4 Cells Count | For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed. | 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. | 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. | Week 48 |
| CD4 Cells Count | For the HIV-2 infected patients CD4 cells count will be assessed at baseline. | Baseline |
| CD4 Cells Count | For the HIV-2 infected patients CD4 cells count will be assessed at week 24. | Week 24 |
| CD4 Cells Count | For the HIV-2 infected patients CD4 cells count will be assessed at week 48. | 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. | 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. | 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. | 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. | Week 48 |
| Lost to Follow-up |
|
Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
| BG002 | HIV-2 With Therapeutic Failure | Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| HIV-2 With Therapeutic Failure |
Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment) |
|
|
|
| Primary | HIV-RNA Levels | Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24. | Posted | Number | participants | week 24 |
|
|
|
| Primary | HIV-RNA Levels | Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48. | Posted | Number | participants | week 48 |
|
|
|
| Primary | CD4 Cells Count | CD4 cells count at baseline. | Posted | Median | Full Range | cells/mm^3 | Baseline |
|
|
|
|
| Secondary | 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. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | 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. | Posted | Number | participants | Week 24 |
|
|
|
| Secondary | 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. | Posted | Number | participants | Week 48 |
|
|
|
| Secondary | CD4 Cells Count | For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed. | Posted | Median | Full Range | cells/mm^3 | Baseline |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | cells/mm^3 | Week 24 |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | cells/mm^3 | Week 48 |
|
|
|
| Secondary | CD4 Cells Count | For the HIV-2 infected patients CD4 cells count will be assessed at baseline. | Posted | Median | Full Range | cells/mm^3 | Baseline |
|
|
|
| Secondary | CD4 Cells Count | For the HIV-2 infected patients CD4 cells count will be assessed at week 24. | Posted | Median | Full Range | cells/mm^3 | Week 24 |
|
|
|
| Secondary | CD4 Cells Count | For the HIV-2 infected patients CD4 cells count will be assessed at week 48. | Posted | Median | Full Range | cells/mm^3 | Week 48 |
|
|
|
| Secondary | 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. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | 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. | Posted | Number | participants | Week 24 |
|
|
|
| Secondary | 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. | Posted | Number | participants | Week 48 |
|
|
|
| Primary | CD4 Cells Count | CD4 cells count at week 24. | Posted | Median | Full Range | cells/mm^3 | week 24 |
|
|
|
|
| Primary | CD4 Cells Count | CD4 cells count at week 48. | Posted | Median | Full Range | cells/mm^3 | week 48 |
|
|
|
|
| Secondary | 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. | Posted | Number | participants | Week 48 |
|
|
|
| 3 |
| 107 |
| 7 |
| 107 |
| EG001 | HIV With Need for Therapy Change | Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20) | 0 | 24 | 1 | 24 |
| EG002 | HIV-2 With Therapeutic Failure | Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment) | 0 | 20 | 1 | 20 |
| Toxidermia | Skin and subcutaneous tissue disorders |
|
| Anemia | Surgical and medical procedures |
|
| Diarrhea | Gastrointestinal disorders |
|
| Hallucinations | Psychiatric disorders |
|
| Anemia | Blood and lymphatic system disorders |
|
| Elevated CPK | Metabolism and nutrition disorders |
|
| Elevated AST/ALT | Metabolism and nutrition disorders |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| Title | Measurements |
|---|---|
|
| Missing value |
|
| Title | Measurements |
|---|---|
|
| Missing value |
|
|
| Patients that discontinued due to adverse reaction |
|