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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
tenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg
tenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg
tenofovir 245 mg / lamivudine 300 mg / raltegravir 800 mg
Hospital Genral de Nova Iguaçu
Nova Iguaçu, Brazil
Hospital Nossa Senhora da Coceiçao
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, France
Hôpital Saint-Louis
Paris, France
CHI Villeneuve Saint Georges
Villeneuve-Saint-Georges, France
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
Time frame: 24 weeks
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
Time frame: 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
Time frame: 24 and 48 weeks
Evolution in HIV RNA and HIV DNA (total and 2 LTR circular) from baseline to week 48
Time frame: 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
Time frame: At the time of virologic failure
Evolution of CD4 cell counts from baseline to week 48
Time frame: 48 weeks
Frequency, type and time to a new AIDS-defining event or death
Time frame: Through out the trial
Frequency, type, time to grade 3 or 4 adverse event
Time frame: Through out the trial
Rate of success of TB treatment
Time frame: 48 weeks
Anti-TB resistance rate
Time frame: 48 weeks
Evolution of raltegravir and efavirenz trough concentration
Time frame: Through out the trial
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