Annals of internal medicine · 2020
Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial.
Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Lévy Yves, Lelièvre Jean-Daniel, Assoumou Lambert, Aznar Esther, Pulido Federico, Tambussi Giuseppe, Crespo Manuel, Meybeck Agnès, Molina Jean-Michel, Delaugerre Constance, Izopet Jacques, Peytavin Gilles, Cardon Fanny, Diallo Alpha, Lancar Rémi, Béniguel Lydie, Costagliola Dominique
Аннотация
BACKGROUND: Patients diagnosed with advanced HIV infection have a poor prognosis despite initiation of combined antiretroviral therapy (c-ART).
OBJECTIVE: To assess the benefit of adding maraviroc, an antiretroviral drug with immunologic effects, to standard c-ART for patients with advanced disease at HIV diagnosis.
DESIGN: Randomized controlled trial. (ClinicalTrials.gov: NCT01348308).
SETTING: Clinical sites in France (n = 25), Italy (n = 5), and Spain (n = 20).
PARTICIPANTS: 416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200 × 109 cells/L and/or a previous AIDS-defining event (ADE).
INTERVENTION: C-ART plus placebo or maraviroc (300 mg twice daily with dose modification) for 72 weeks.
MEASUREMENTS: The primary end point was first occurrence of severe morbidity (new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome, or death). Prespecified secondary outcomes included primary outcome components, biological and pharmacokinetic measures, and adverse events graded 2 or higher.
RESULTS: 409 randomly assigned participants (207 in the placebo group and 202 in the maraviroc group) who received more than 1 dose were included in the analysis. During 72 weeks of follow-up, incidence of severe morbidity was 11.1 per 100 person-years in the maraviroc group and 11.2 per 100 person-years in the placebo group (hazard ratio, 0.97 [95% CI, 0.57 to 1.67]). Incidence of adverse events graded 2 or higher was 36.1 versus 41.5 per 100 person-years (incidence rate ratio, 0.87 [CI, 0.65 to 1.15]).
LIMITATIONS: Sixty-four participants discontinued therapy during follow-up. The study was not designed to evaluate time-dependent outcomes or effect modification.
CONCLUSION: Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
PRIMARY FUNDING SOURCE: INSERM-ANRS (French National Agency for Research on AIDS).
OBJECTIVE: To assess the benefit of adding maraviroc, an antiretroviral drug with immunologic effects, to standard c-ART for patients with advanced disease at HIV diagnosis.
DESIGN: Randomized controlled trial. (ClinicalTrials.gov: NCT01348308).
SETTING: Clinical sites in France (n = 25), Italy (n = 5), and Spain (n = 20).
PARTICIPANTS: 416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200 × 109 cells/L and/or a previous AIDS-defining event (ADE).
INTERVENTION: C-ART plus placebo or maraviroc (300 mg twice daily with dose modification) for 72 weeks.
MEASUREMENTS: The primary end point was first occurrence of severe morbidity (new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome, or death). Prespecified secondary outcomes included primary outcome components, biological and pharmacokinetic measures, and adverse events graded 2 or higher.
RESULTS: 409 randomly assigned participants (207 in the placebo group and 202 in the maraviroc group) who received more than 1 dose were included in the analysis. During 72 weeks of follow-up, incidence of severe morbidity was 11.1 per 100 person-years in the maraviroc group and 11.2 per 100 person-years in the placebo group (hazard ratio, 0.97 [95% CI, 0.57 to 1.67]). Incidence of adverse events graded 2 or higher was 36.1 versus 41.5 per 100 person-years (incidence rate ratio, 0.87 [CI, 0.65 to 1.15]).
LIMITATIONS: Sixty-four participants discontinued therapy during follow-up. The study was not designed to evaluate time-dependent outcomes or effect modification.
CONCLUSION: Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
PRIMARY FUNDING SOURCE: INSERM-ANRS (French National Agency for Research on AIDS).