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| Name | Class |
|---|---|
| Triangle Pharmaceuticals | INDUSTRY |
| Gilead Sciences | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
| Dupont Applied Biosciences |
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The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.
The trial is prolonged for a total of 48 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emtricitabine, FTC (drug) | Drug | |||
| didanosine, ddI (drug) | Drug | |||
| efavirenz (drug) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Virological success from W0 to W48 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of HIV infection | ||
| CD4 cell count | ||
| Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel Molina, MD, PhD | Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France | Principal Investigator |
| Genevieve Chene, MD, PhD | INSERM unité 593, Bordeaux, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Maladies Infectieuses, Hôpital Saint-Louis | Paris | 75475 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21036772 | Result | Gallien S, Journot V, Rozenbaum W, Yeni P, Morlat P, Poizot-Martin I, Reynes J, Reliquet V, Leclercq P, Simon F, Chene G, Molina JM; ALIZE (ANRS 099) Study Group. Four year follow-up of simplification therapy with once-daily emtricitabine, didanosine and efavirenz in HIV-infected patients (ALIZE ANRS 099 trial). J Antimicrob Chemother. 2011 Jan;66(1):184-91. doi: 10.1093/jac/dkq395. Epub 2010 Oct 28. | |
| 15717256 |
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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 |
|---|---|
| D000068679 | Emtricitabine |
| C075889 | Racivir |
| D004364 | Pharmaceutical Preparations |
| D016049 | Didanosine |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| INDUSTRY |
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| Treatment adherence |
| Quality of life |
| Viral mutations |
| Therapeutic strategy failure |
| Result |
| Molina JM, Journot V, Morand-Joubert L, Yeni P, Rozenbaum W, Rancinan C, Fournier S, Morlat P, Palmer P, Dupont B, Goujard C, Dellamonica P, Collin F, Poizot-Martin I, Chene G; ALIZE (Agence Nationale de Recherches sur le SIDA 099) Study Team. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. J Infect Dis. 2005 Mar 15;191(6):830-9. doi: 10.1086/428091. Epub 2005 Feb 10. |
| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015224 | Dideoxynucleosides |
| D012263 | Ribonucleosides |