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| Name | Class |
|---|---|
| University of Liege | OTHER |
| Ministry of Public Health, Democratic Republic of the Congo | OTHER_GOV |
| Pierre and Marie Curie University | OTHER |
| University Paris 7 - Denis Diderot |
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In resource-limited setting, concerns remain regarding the emergence of virologic failure and high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for Human immunodeficiency virus 1 (HIV1) infected patients. The study hypothesis is that a boosted-protease inhibitor regimen has a better outcome than a NNRTI-based regimen with a low genetic barrier to resistance.
The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment- naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP) each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine (3TC). The primary end point is the incidence of therapeutic (clinical and/or virologic)failure by study week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nevirapine and tenofovir/emtricitabine | Active Comparator | nevirapine 200 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks |
|
| lopinavir/r and tenofovir/emtricitabine | Experimental | ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks |
|
| Nevirapine and zidovudine/lamivudine | Active Comparator | nevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks |
|
| Lopinavir/r and zidovudine/lamivudine | Experimental | ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg once daily combined with zidovudine 300 mg/lamivudine 150 mg once daily, per os for 96 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nevirapine | Drug | Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of therapeutic failure | The primary end point is the proportion of patients with therapeutic failure defined as:
| At week 48 with follow-up until week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA viral load less than 50 copies/ml | The percentage of patients with HIV-1 RNA < 50 copies/ml | Through week 96 |
| Immunologic response | Cluster of differentiation 4 (CD4) cell count change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Clumeck, MD, PhD | Centre Hospitalier Universitaire Saint Pierre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires de Lubumbashi | Lubumbashi | Katanga | Republic of the Congo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25028911 | Derived | Clumeck N, Mwamba C, Kabeya K, Matanda S, Vaira D, Necsoi C, Kadiebwe D, Delforge M, Kasamba E, Milolo C, Ilunga J, Kapend L. First-line antiretroviral therapy with nevirapine versus lopinavir-ritonavir based regimens in a resource-limited setting. AIDS. 2014 May 15;28(8):1143-53. doi: 10.1097/QAD.0000000000000214. |
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| OTHER |
| Gilead Sciences | INDUSTRY |
| Abbott | INDUSTRY |
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|
| ritonavir-boosted Lopinavir | Drug | ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks |
|
|
| Tenofovir/emtricitabine | Drug | tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks |
|
|
| Zidovudine/lamivudine | Drug | zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks |
|
|
| Through week 96 |
| HIV-1 resistance mutations | At baseline and at the time of virologic failure |
| Safety and tolerability | Incidence of adverse events and laboratory abnormalities | Through week 96 |
| Changes in laboratory parameters | Through week 96 |
| ID | Term |
|---|---|
| D019829 | Nevirapine |
| C558899 | lopinavir-ritonavir drug combination |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C109078 | lamivudine, zidovudine drug combination |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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