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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005981-39 | EudraCT Number |
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Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lopinavir/ritonavir 800 mg / 200mg | Other | Kaletra 200/50 mg comprimidos recubiertos con pelĂcula Lopinavir/ritonavir 800 mg / 200mg will be changed from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir 800 mg / 200mg | Drug | Lopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| plasma viral load <40 copies/mL | HIV Plasma Viral Load <40 copies/ml at week 48. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Stability in the plasma levels of Lopinavir/ritonavir during all study visits | Determination of plasma concentrations of the study drug at weeks 4, 8, 12, 16, 24, 36 and 48 | Weeks 4, 8, 12, 16, 24, 36 and 48 |
| Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Podzamczer, MD | Hospital Universitari de Bellvitge | Principal Investigator |
| Hernando Knobel, MD | Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Bercelona | Barcelona | 08003 | Spain | ||
| Hospital Universitary de Bellvitge |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Possible Adverse Events will be collected in all study visits and laboratory tests will also be performed in all study visits (weeks 4, 8, 12, 16, 24, 36 and 48)
| Weeks 4, 8, 12, 16, 24, 36 and 48 |
| Adherence | Medication adherence will be evaluated in all the study visits after making a reconciliation of the medication dispensed and returned by the patients | Weeks 4, 8, 12, 16, 24, 36 and 48 |
| Satisfaction | Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ) | Weeks 4, 8, 12, 16, 24, 36 and 48 |
| - Efficacy in CSF | - In a subsample of patients (10) HIV-1 RNA in CSF will be assessed (added as per amendment) | At least 4 weeks on study treatment |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |