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| Name | Class |
|---|---|
| Triangle Pharmaceuticals | INDUSTRY |
| Gilead Sciences | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
| Dupont Applied Biosciences |
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In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.
In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Side effects of this products and the number of pills may induce a lower adherence, and thus a lower efficacy. 40 patients with a CD4 count over 100/mm3, a HIV RNA over 5,000 copies/ml and antiretroviral naive, take the once daily combination of FTC, ddI, efavirenz during 24 weeks. The primary end-point is the viral success maintained from 12 weeks until 24 weeks. Secondary end-point is the adherence to the association and safety.
The trial is prolonged during a total of 72 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence | ||
| 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 |
|---|---|---|---|
| 10915095 | Background | Molina JM, Ferchal F, Rancinan C, Raffi F, Rozenbaum W, Sereni D, Morlat P, Journot V, Decazes JM, Chene G. Once-daily combination therapy with emtricitabine, didanosine, and efavirenz in human immunodeficiency virus-infected patients. J Infect Dis. 2000 Aug;182(2):599-602. doi: 10.1086/315711. Epub 2000 Jul 13. | |
| 15012649 | Background |
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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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| Progression of HIV infection |
| Pharmacokinetics criteria |
| Molina JM, Peytavin G, Perusat S, Lascoux-Combes C, Sereni D, Rozenbaum W, Chene G. Pharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial). HIV Med. 2004 Mar;5(2):99-104. doi: 10.1111/j.1468-1293.2004.00194.x. |
| 17591032 | Result | Molina JM, Journot V, Furco A, Palmer P, De Castro N, Raffi F, Morlat P, May T, Rancinan C, Chene G; Montana (ANRS 091) Study Group. Five-year follow up of once-daily therapy with emtricitabine, didanosine and efavirenz (Montana ANRS 091 trial). Antivir Ther. 2007;12(3):417-22. |
| 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 |