1. Intensification of Antiretroviral Therapy through Addition of Enfuvirtide in Naive HIV-1-Infected Patients with Severe Immunosuppression Does Not Improve Immunological Response: Results of a Randomized Multicenter Trial (ANRS 130 Apollo)
- Author
-
Charlotte Charpentier, Véronique Joly, Carine Grondin, Sophie Tabuteau, Yazdan Yazdanpanah, François Raffi, André Cabié, Catherine Fagard, Patrick Yeni, Geneviève Chêne, Nathalie Colin de Verdiere, Diane Descamps, Service de maladies infectieuses et tropicales, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Virologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Modélisation, Aide à la Décision, et Coût-Efficacité en Maladies Infectieuses (ATIP-Avenir Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM), Service des Maladies Infectieuses et Tropicales, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Maladies infectieuses et tropicales, Centre d'Investigation Clinique Antilles-Guyane (CIC - Antilles Guyane), CHU de Fort de France-Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française]-CHU Pointe-à-Pitre/Abymes [Guadeloupe] -Institut National de la Santé et de la Recherche Médicale (INSERM)-Université des Antilles et de la Guyane (UAG), ANRS (French National Agency for Research on AIDS and Viral Hepatitis), ANRS 130 Apollo Trial Group, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université des Antilles et de la Guyane (UAG)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pointe-à-Pitre/Abymes [Guadeloupe] -CHU de Fort de France-Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française], Le Corre, Morgane, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Université Bordeaux Segalen - Bordeaux 2
- Subjects
CD4-Positive T-Lymphocytes ,Cyclopropanes ,Male ,Enfuvirtide ,MESH: CD4 Lymphocyte Count ,MESH: HIV Envelope Protein gp41 ,HIV Infections ,Deoxycytidine ,MESH: Antiretroviral Therapy, Highly Active ,Lopinavir ,MESH: HIV-1 ,chemistry.chemical_compound ,0302 clinical medicine ,Antiretroviral Therapy, Highly Active ,Emtricitabine ,Pharmacology (medical) ,030212 general & internal medicine ,MESH: Anti-HIV Agents ,MESH: Peptide Fragments ,MESH: Treatment Outcome ,0303 health sciences ,MESH: Lopinavir ,MESH: CD4-Positive T-Lymphocytes ,virus diseases ,MESH: HIV Infections ,Viral Load ,HIV Envelope Protein gp41 ,3. Good health ,Drug Combinations ,[SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology ,Treatment Outcome ,Infectious Diseases ,MESH: RNA, Viral ,MESH: Benzoxazines ,Alkynes ,RNA, Viral ,Female ,medicine.symptom ,MESH: Viral Load ,MESH: Organophosphonates ,Viral load ,medicine.drug ,Adult ,medicine.medical_specialty ,MESH: Adenine ,MESH: Immune Tolerance ,Efavirenz ,Anti-HIV Agents ,Organophosphonates ,Antiviral Agents ,Asymptomatic ,03 medical and health sciences ,Multicenter trial ,Internal medicine ,Immune Tolerance ,medicine ,Humans ,Tenofovir ,[SDV.MP] Life Sciences [q-bio]/Microbiology and Parasitology ,MESH: Drug Combinations ,Pharmacology ,MESH: Humans ,Ritonavir ,030306 microbiology ,business.industry ,Adenine ,MESH: Deoxycytidine ,MESH: Adult ,MESH: Male ,Peptide Fragments ,Benzoxazines ,CD4 Lymphocyte Count ,Surgery ,chemistry ,HIV-1 ,MESH: Ritonavir ,business ,MESH: Female - Abstract
We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of 3 or stage B/C disease with CD4 counts of 3 . Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥200/mm 3 at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm 3 , and the median HIV-1 RNA load was 5.4 log 10 copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥200/mm 3 at week 24 were 34% and 38% in the ENF and control arms, respectively ( P = 0.53). The proportions of patients with HIV-1 RNA loads of P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up ( P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression.
- Published
- 2013
- Full Text
- View/download PDF