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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000948-25 |
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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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The purpose of this study is to evaluate if there are pharmacokinetic interactions between the NRTI 3TC and ABV, and the TDF nucleotide. For this purpose, the intracellular and plasma levels of 3TC and ABV will be compared in patients given these nucleosides with TDF and 30 days after the interruption of the TDF.
There is clear evidence of pharmacokinetic interaction between ddI+TDF. However, the interaction between TDF and other NRTIs, mainly at intracellular level, has not been so well studied.
Since all the NRTIs are anabolized at intracellular level by numerous kinases, and are transported by passive carrier systems, the interaction may be between TDF and other NRTIs.
This study aims to investigate the pharmacokinetic interactions between the TDF and the nucleosides abacavir (ABV) and lamivudine (3TC) at plasma and intracellular level.
With this objective, intracellular and plasma levels will be analysed in a group of patients that receive the combinations 3TC +TDF, ABV+TDF and 3TC+ABV+TDF together with lopinavir/rtv or nevirapine. Subsequently, in a second phase of the study, in the group of patients given ABV and/or 3TC + TDF + lopinavir/rtv, the pharmacokinetic determinations will be repeated after a 4-week interruption of the TDF .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Phase I: 3TC + TDF + NVP or LPV/rtv Phase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: 3TC + LPV/rtv |
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| 2 | Experimental | Phase I: ABV + TDF + NVP or LPV/rtv Phase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: ABV + LPV/rtv |
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| 3 | Experimental | Phase I: 3TC + ABV + TDF + NVP or LPV/rtv Phase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: 3TC + ABV + LPV/rtv |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients in treatment with 3TC + TDF + LPV/rtv, stop tenofovir during 4 weeks | Drug | 3TC (300 mg/24 h, 1 tablet/24 h) + Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h) |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be the variation between the intracellular levels of 3TC and ABC before and after the interruption of the treatment with TDF | At baseline and week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Variations between the plasma levels of 3TC and ABC before and after interruption of the treatment with TDF. | at baseline and week 4 | |
| Correlation between the intracellular and plasma levels of 3TC, ABC and TDF. | at baseline and week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonaventura Clotet, MD,PhD | LLuita contra la Sida Foundation-HIV Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
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| Patients in treatment with ABV + TDF + LPV/rtv, stop tenofovir during 4 weeks | Drug | ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h) |
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| Patients in treatment with 3TC + ABV + TDF+ LPV/rtv, stop TDF during 4 weeks | Drug | 3TC (300 mg/24 h, 1 tablet/24 h)+ ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h). |
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| Changes in the intracellular levels of TDF following the withdrawal of the drug. | At week 4. |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019259 | Lamivudine |
| C558899 | lopinavir-ritonavir drug combination |
| C036986 | VBA protocol |
| C106538 | abacavir |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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