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- Title
Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial.
- Authors
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
- Abstract
<bold>Background: </bold>Patients diagnosed with advanced HIV infection have a poor prognosis despite initiation of combined antiretroviral therapy (c-ART).<bold>Objective: </bold>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.<bold>Design: </bold>Randomized controlled trial. (ClinicalTrials.gov: NCT01348308).<bold>Setting: </bold>Clinical sites in France (n = 25), Italy (n = 5), and Spain (n = 20).<bold>Participants: </bold>416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200 × 109 cells/L and/or a previous AIDS-defining event (ADE).<bold>Intervention: </bold>C-ART plus placebo or maraviroc (300 mg twice daily with dose modification) for 72 weeks.<bold>Measurements: </bold>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.<bold>Results: </bold>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]).<bold>Limitations: </bold>Sixty-four participants discontinued therapy during follow-up. The study was not designed to evaluate time-dependent outcomes or effect modification.<bold>Conclusion: </bold>Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.<bold>Primary Funding Source: </bold>INSERM-ANRS (French National Agency for Research on AIDS).
- Subjects
IMMUNE reconstitution inflammatory syndrome; HIV infections; ANTIRETROVIRAL agents; PHARMACOLOGY; PLACEBOS; ANTI-HIV agents; RESEARCH; VIRAL load; RESEARCH methodology; ANTIVIRAL agents; EVALUATION research; MEDICAL cooperation; HIGHLY active antiretroviral therapy; TREATMENT effectiveness; COMPARATIVE studies; BLIND experiment; CD4 lymphocyte count; HIV
- Publication
Annals of Internal Medicine, 2020, Vol 172, Issue 5, p297
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/M19-2133