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| Name | Class |
|---|---|
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | OTHER |
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Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
The probability of achieving viral replication suppression during the treatment with DRV has been related to both the extent of viral resistance to DRV (inhibitory concentration 50%, IC50) and the drug concentration. Moreover, the DRV virtual inhibitory quotient (vIQ) has been related significantly with the virological response to DRV treatment. So patients with a DRV vIQ >= 1,5 had a 8-times higher probability of having viral load < 50 copies/mL after 24 weeks of treatment than those having a vIQ < 1,5.
Considering the previous arguments, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a DRV vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Darunavir 900mg + ritonavir 100 mg once a day |
|
| 2 | Active Comparator | Darunavir 600mg + ritonavir 100mg twice day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir 900mg + ritonavir 100 mg once a day | Drug | Darunavir 900mg + ritonavir 100 mg once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HIV-1 viral load < 50 copies /mL | Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| DRV plasma trough concentration | Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 | |
| DRV Virtual inhibitory quotient (vIQ) | Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonaventura Clotet, MD,PhD | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol Hospital | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20386077 | Derived | Molto J, Valle M, Santos JR, Mothe B, Miranda C, Cedeno S, Negredo E, Yritia M, Videla S, Barbanoj MJ, Clotet B. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. doi: 10.3851/IMP1519. |
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| Darunavir 600mg + ritonavir 100mg twice day |
| Drug |
Darunavir 600mg + ritonavir 100mg twice day |
|
| CD4 and CD8 lymphocytes count | Screening, Basal, week 12, week 24, week 36 and week 48 |
| Physical examination including weight and height | Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 |
| Karnofsky index | Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48 |
| Adverse events | Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 |
| Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides) | Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 |
| Treatment adherence (assessed by the physician, but not recovered in the data base) | Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 |
| Genotype, if virological failure occurs | When virological failure |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
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| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
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