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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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Raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown.
This phase II open-label randomized multicenter trial is designed to estimate the antiviral efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive patients co-infected with active tuberculosis (TB) treated with rifampin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | efavirenz |
|
| 2 | Experimental | raltegravir 400 mg |
|
| 3 | Experimental | raltegravir 800 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efavirenz | Drug | tenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic success, using Time to Loss of Virologic Response (TLOVR) algorithm: -Plasma HIV RNA below 50 copies/ml at week 20, confirmed at week 24 -Absence of permanent treatment discontinuation -Absence of death -Still follow-up at week 24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with virologic response with the following definitions: - Plasma HIV RNA <50 copies/ml at week 24 - Rate of strategy discontinuation and treatment changes - Proportion of death - Proportion of patients loss to follow-up | 24 weeks | |
| Proportion of patients with virologic response with the following definitions: o Plasma HIV RNA <50 copies/ml o Plasma HIV RNA <400 copies/ml |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatriz Grinsztejn, MD | Fiocruz, Rio de Janiero, Brazil | Study Chair |
| Jean-Michel Molina, MD | Hôpital Saint-Louis, Paris, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Genral de Nova Iguaçu | Nova Iguaçu | Brazil | ||||
| Hospital Nossa Senhora da Coceiçao |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24726095 | Derived | Grinsztejn B, De Castro N, Arnold V, Veloso VG, Morgado M, Pilotto JH, Brites C, Madruga JV, Barcellos NT, Santos BR, Vorsatz C, Fagard C, Santini-Oliveira M, Patey O, Delaugerre C, Chene G, Molina JM; ANRS 12 180 Reflate TB study group. Raltegravir for the treatment of patients co-infected with HIV and tuberculosis (ANRS 12 180 Reflate TB): a multicentre, phase 2, non-comparative, open-label, randomised trial. Lancet Infect Dis. 2014 Jun;14(6):459-67. doi: 10.1016/S1473-3099(14)70711-X. Epub 2014 Apr 9. |
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| raltegravir |
| Drug |
tenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg |
|
| raltegravir | Drug | tenofovir 245 mg / lamivudine 300 mg / raltegravir 800 mg |
|
| 24 and 48 weeks |
| Evolution in HIV RNA and HIV DNA (total and 2 LTR circular) from baseline to week 48 | 48 weeks |
| Rate of viral resistance mutations in the plasma at the time of virologic failure and in comparison with HIV-RNA mutations at W0 | At the time of virologic failure |
| Evolution of CD4 cell counts from baseline to week 48 | 48 weeks |
| Frequency, type and time to a new AIDS-defining event or death | Through out the trial |
| Frequency, type, time to grade 3 or 4 adverse event | Through out the trial |
| Rate of success of TB treatment | 48 weeks |
| Anti-TB resistance rate | 48 weeks |
| Evolution of raltegravir and efavirenz trough concentration | Through out the trial |
| Porto Alegre |
| Brazil |
| Hospital Sanatorio Pertenon | Porto Alegre | Brazil |
| Ipec/Fiocruz | Rio de Janeiro | Brazil |
| Hospitral Universitario Pr Edgar Santos | Salvador | Brazil |
| STD/AIDS department | São Paulo | Brazil |
| Hôpital Lariboisière | Paris | 75010 | France |
| Hôpital Saint-Louis | Paris | 75010 | France |
| CHI Villeneuve Saint Georges | Villeneuve-Saint-Georges | 94195 | France |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| 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 |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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