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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004885-24 | EudraCT Number |
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The primary objective of the trial is to assess the ability of an early and intermittent antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV infected adults, to offer a potential alternative strategy to differed and continuous antiretroviral treatment.This is a 2-year phase II, open-label, multicentric "proof of concept" trial. The patients included are treated following a pulse-therapy scheme, i.e. 6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods without antiretroviral therapy. The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the efficacy and the tolerance of the strategy, with clinical, biochemical, immunological, virological and pharmacokinetic evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent treatment | Experimental | 6 months on antiretroviral treatment and 6 months off treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured treatment interruption | Drug | The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir Usual dosage recommended :
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with mean CD4 count at M21 and M24 above or equal to the mean CD4 count at screening and inclusion, without experiencing a decrease below 400/mm3 throughout the study. | M21 and M24 |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients following the strategy of the trial and with AIDS related and non AIDS-related (cardiovascular, renal, hepatic, infectious, cancerous) serious clinical event | M12 and M24 | |
| number, type and time to AIDS and non AIDS-related serious clinical events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lionel PIROTH, MD, PHD | Hôpital de Dijon, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services maladies infectieuses et tropicales CHU | Dijon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26568566 | Derived | Piroth L, Moinot L, Yeni P, Avettand-Fenoel V, Reynes J, Girard PM, Marchou B, Georget A, Rouzioux C, Autran B, Duvillard L, Chene G, Fagard C; ANRS 141 TIPI Trial Study Group. Immunity, inflammation and reservoir in patients at an early stage of HIV infection on intermittent ART (ANRS 141 TIPI Trial). J Antimicrob Chemother. 2016 Feb;71(2):490-6. doi: 10.1093/jac/dkv369. Epub 2015 Nov 14. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000097042 | Treatment Interruption |
| D000069446 | Atazanavir Sulfate |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C492871 | abacavir, lamivudine drug combination |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D001294 | Attitude to Health |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
|
| from week 0 to M24 |
| number, type and time to clinical and biological events (whatever the grade of severity) | from week 0 to M24 |
| existence and nature of HIV genotypic mutations associated with antiretroviral resistance | M9 and M24 and at any time visit in case of failure |
| proportion of patients having followed the strategy of the trial | from week 0 to M24 |
| evolution of HIV RNA and HIV DNA throughout the study | from week 0 to M24 for RNA and each 6 months for DNA |
| Quality of life and observance (questionnaires) | QL each 6 months, observance at M1, M6, M13 and M18 |
| 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 |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |