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| ID | Type | Description | Link |
|---|---|---|---|
| IP.07.33011.004 | Other Grant/Funding Number | EDCTP |
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drug procurement issues
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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
| Ludwig-Maximilians - University of Munich | OTHER |
| Institute of Tropical Medicine, Belgium | OTHER |
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In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen.
This multicentre international, randomized, non-blinded phase III trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : Lopinavir | Active Comparator | Emtricitabine/tenofovir :
Lopinavir/ritonavir :
|
|
| Arm B : Atazanavir | Experimental | Lamivudine/tenofovir :
Atazanavir/ritonavir :
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir | Drug | Evaluation of second line antiretroviral regimen including boosted lopinavir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Virological response | Proportion of patients with plasma HIV RNA < 50 copies/mL | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virological response | Proportion of patients with plasma HIV RNA < 400 copies/mL | 12 and 24 weeks |
| Viral resistance | Incidence of resistance mutations after treatment failure (HIV RNA < 1000 copies/mL) |
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Inclusion Criteria:
age 18 and above
out patient
documented HIV-1 infection
first line treatment failure:
satisfactory compliance (>80%) to 1st line antiretroviral treatment
signed informed consent
agreement for contraception for women of childbearing age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Delaporte | Institut de Recherche pour le Developpement | Principal Investigator |
| Issakwisa Mwakyula | NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Tanzania | Principal Investigator |
| Mzileni O Mogiyana | University of Limpopo | Principal Investigator |
| Alexandra Calmy | University of Geneva, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tshepang clinic, Limpopo University | Pretoria | South Africa | ||||
| NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Institut de Recherche pour le Developpement |
| OTHER_GOV |
| Swiss National Science Foundation | OTHER |
| University of Limpopo | OTHER |
| NIMR-Mbeya Medical Research Program (MMRP)/ Mbeya Referral Hospital, Tanzania | UNKNOWN |
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| Atazanavir | Drug | Evaluation of second line antiretroviral regimen including boosted atazanavir |
|
| 12, 24 and 48 weeks |
| Clinical course of HIV infection | Mortality, occurence of clinical events stage 3 or 4 (WHO classification), immune reconstitution sundrome, non-AIDS clinical events including bacterial infections | Up to 48 weeks |
| Tolerance assessment | Proportion of adverse events related to antiretroviral treatment, proportion of treatement discontinuations due to antiretroviral side effect, variation of biological parameters and metabolic markers between second line antiretroviral initiation and 24/48 weeks. | 24 and 48 weeks |
| Adherence assessment | Measurement of pills consumption at each visit, face-to-face questionnaire with the pharmacist | At each protocol visit : week 2, 4, 12, 24, 36 and 48 |
| Hepatitis B evaluation | Prevalence of HBs AG, HBe Ag, HBV viremia, and HBV asociated drug resistance mutations at baseline | At entry |
| Immunologic response | Variation of circulating total and CD4+ lymphocyte count between second line treatment initiation and 24 weeks/48 weeks | 24 and 48 weeks |
| Mbeya |
| Tanzania |
| D011725 |
| Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |