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| ID | Type | Description | Link |
|---|---|---|---|
| IMEA 025 |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | OTHER |
In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment available for HIV-1 infected patients. The combination proposed is a triple antiretroviral therapy with only one intake of 3 pills per day. This combination has already been studied in the North countries.
Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir (TDF) | Drug | |||
| Emtricitabine (FTC) | Drug | |||
| Efavirenz (EFV) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population | S48 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml | S24 and S96 | |
| Viral load evolution | S24 and S48 | |
| Genotype resistance profile evaluation failing patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland Landman | IMEA- Hôpital Bichat Claude Bernard, France | Study Chair |
| Papa Salif Sow | CHU de Fann, Dakar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Traitement Ambulatoire, CHU de Fann | Dakar | Senegal | ||||
| Service des Maladies Infectieuses, CHU de Fann |
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| S24, S48, S96 |
| Immune benefits of the combination |
| Plasma concentrations of FTC, TDF and EFV | S4 |
| Adverse events clinic and lipids |
| Compliance | S48 and S96 |
| Dakar |
| Senegal |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| C075889 | Racivir |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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