A pilot trial of adding maraviroc to suppressive antiretroviral therapy for suboptimal CD4+ T-cell recovery despite sustained virologic suppression: ACTG A5256

Journal of Infectious Diseases

Volumn 206, Issue 4, 2012, Pages 534-542

  Wilkin, Timothy J ^a   Lalama, Christina M ^b   McKinnon, John ^c   Gandhi, Rajesh T ^d,e   Lin, Nina ^d,f   Landay, Alan ^g   Ribaudo, Heather ^b   Fox, Lawrence ^h   Currier, Judith S ⁱ   Mellors, John W ^c   Gulick, Roy ^a   Tenorio, Allan R ^g,j  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b CENTER FOR BIOSTATISTICS IN AIDS RESEARCH   (United States)

^c UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e Ragon Institute   (United States)

^f HARVARD MEDICAL SCHOOL   (United States)

^g RUSH UNIVERSITY   (United States)

^h NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j UNIVERSITY OF THE PHILIPPINES MANILA   (Philippines)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; MARAVIROC; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; PROTEINASE INHIBITOR; RALTEGRAVIR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; VIRUS RNA; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; CYCLOHEXANE DERIVATIVE; TRIAZOLE DERIVATIVE;

ADOLESCENT; ADULT; APOPTOSIS; ARTICLE; BRADYCARDIA; CD4 LYMPHOCYTE COUNT; CD8+ T LYMPHOCYTE; CLINICAL ARTICLE; DYSPNEA; FEMALE; FOLLOW UP; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERGLYCEMIA; HYPOALBUMINEMIA; HYPOCALCEMIA; LYMPHOCYTE PROLIFERATION; MALE; MULTICENTER STUDY; PILOT STUDY; PRIORITY JOURNAL; SENESCENCE; T LYMPHOCYTE SUBPOPULATION; VIROLOGY; AGED; CLINICAL TRIAL; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOLOGY; ISOLATION AND PURIFICATION; METHODOLOGY; MIDDLE AGED; VIRUS LOAD;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4 LYMPHOCYTE COUNT; CYCLOHEXANES; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; TRIAZOLES; VIRAL LOAD; YOUNG ADULT;

EID: 84866951694     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jis376     Document Type: Article

References (35)

1. Bartlett JA, Fath MJ, Demasi R, et al. An updated systematic overview of triple combination therapy in antiretroviral-naive HIV-infected adults. AIDS 2006; 20:2051-64.
2. Grabar S, Le Moing V, Goujard C, et al. Clinical outcome of patients with HIV-1 infection according to immunologic and virologic response after 6 months of highly active antiretroviral therapy. Ann Intern Med 2000; 133:401-10.
3. Chene G, Sterne JA, May M, et al. Prognostic importance of initial response in HIV-1 infected patients starting potent antiretroviral therapy: analysis of prospective studies. Lancet 2003; 362:679-86.
4. Study Group on Death Rates at High CD4 Count in Antiretroviral Naive Patients, Lodwick RK, Sabin CA, et al. Death rates in HIVpositive antiretroviral-naive patients with CD4 count greater than 350 cells per microL in Europe and North America: a pooled cohort observational study. Lancet 2010; 376:340-5.
5. Bruyand M, Thiebaut R, Lawson-Ayayi S, et al. Immunodeficiency and risk of AIDS-defining and non-AIDS-defining cancers: ANRS CO3 Aquitaine Cohort, 1998 to 2006 [abstract 15]. Paper presented at: 15th Conference on Retroviruses and Opportunistic Infections; 4 February 2008; Boston, MA
6. Wilkin TJ, Ribaudo HR, Tenorio AR, Gulick RM. The relationship of CCR5 antagonists to CD4+ T-cell gain: a meta-regression of recent clinical trials in treatment-experienced HIV-infected patients. HIV Clin Trials 2010; 11:351-8.
7. Cooper DA, Heera J, Goodrich J, et al. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis 2010; 201:803-13.
8. Lin NH, Negusse DM, Beroukhim R, et al. The design and validation of a novel phenotypic assay to determine HIV-1 coreceptor usage of clinical isolates. J Virol Methods 2010; 169:39-46.
9. INSIGHT-ESPRIT Study Group, SILCAAT Scientific Committee, Abrams D, et al. Interleukin-2 therapy in patients with HIV infection. N Engl J Med 2009; 361:1548-59.
10. Teixeira L, Valdez H, McCune JM, et al. Poor CD4 T cell restoration after suppression of HIV-1 replication may reflect lower thymic function. AIDS 2001; 15:1749-56.
11. Garcia F, de Lazzari E, Plana M, et al. Long-term CD4+ T-cell response to highly active antiretroviral therapy according to baseline CD4+ T-cell count. J Acquir Immune Defic Syndr 2004; 36:702-13.
12. Huttner AC, Kaufmann GR, Battegay M, et al. Treatment initiation with zidovudine-containing potent antiretroviral therapy impairs CD4 cell count recovery but not clinical efficacy. AIDS 2007; 21:939-46.
13. Negredo E, Molto J, Burger D, et al. Unexpected CD4 cell count decline in patients receiving didanosine and tenofovir-based regimens despite undetectable viral load. AIDS 2004; 18:459-63.
14. Massanella M, Negredo E, Pérez-Alvarez N, et al. CD4 T-cell hyperactivation and susceptibility to cell death determine poor CD4 T-cell recovery during suppressive HAART. AIDS 2010; 24:959-68.
15. Negredo E, Massanella M, Puig J, et al. Nadir CD4 T cell count as predictor and high CD4 T cell intrinsic apoptosis as final mechanism of poor CD4 T cell recovery in virologically suppressed HIV-infected patients: clinical implications. Clin Infect Dis 2010; 50:1300-8.
16. Benveniste O, Flahault A, Rollot F, et al. Mechanisms involved in the low-level regeneration of CD4+ cells in HIV-1-infected patients receiving highly active antiretroviral therapy who have prolonged undetectable plasma viral loads. J Infect Dis 2005; 191:1670-9.
17. Goicoechea M, Smith DM, Liu L, et al. Determinants of CD4+ T-cell recovery during suppressive antiretroviral therapy: association of immune activation, T cell maturation markers and cellular HIV-1 DNA. J Infect Dis 2006; 194:29-37.
18. Gandhi RT, Spritzler J, Chan E, et al. Effect of baseline- and treatment- related factors on immunologic recovery after initiation of antiretroviral therapy in HIV-1-positive subjects: results from ACTG 384. JAIDS 2006; 42:426-34.
19. Mildvan D, Bosch RJ, Kim RS, et al. Immunophenotypic markers and antiretroviral therapy: T-cell activation and maturation help predict treatment response. J Infect Dis 2004; 189:1811-20.
20. Camargo JF, Quinones MP, Mummidi S, et al. CCR5 expression levels influence NFAT translocation, IL-2 production, and subsequent signaling events during T lymphocyte activation. J Immunol 2009; 182:171-82.
21. Castellino F, Huang AY, Altan-Bonnet G, et al. Chemokines enhance immunity by guiding naive CD8+ T cells to sites of CD4+ T cell-dendritic cell interaction. Nature 2006; 440:890-5.
22. Crane IJ, Xu H, Wallace C, Manivannan A, et al. Involvement of CCR5 in the passage of Th1-type cells across the blood-retina barrier in experimental autoimmune uveitis. J Leukoc Biol 2006; 79:435-43.
23. Nieto M, Frade JM, Sancho D, Mellado M, Martinez-A C, Sánchez- Madrid F. Polarization of chemokine receptors to the leading edge during lymphocyte chemotaxis. J Exp Med 1997; 186:153-8.
24. Rossi R, Lichtner M, De Rosa A, et al. In vitro effect of anti-human immunodeficiency virus CCR5 antagonist maraviroc on chemotactic activity of monocytes, macrophages and dendritic cells. Clin Exp Immunol 2011; 166:184-90.
25. Hunt P, Shulman N, Hayes T, et al. Immunomodulatory effects of MVC intensification in HIV-infected individuals with incomplete CD4+ T cell recovery during suppressive ART [abstract 153LB]. In: Program and abstracts of the 18th Conference on Retroviruses and Opportunistic Infections (Boston, MA). Alexandria VA: Foundation for Retrovirology and Human Health, 2011.
26. Rusconi S, Colella E, Adorni F, et al. ANRS 145 maraviroc (MVC) as intensification strategy in immunological nonresponder HIV-infected patients with virologic success on HAART [abstract PS1/7]. In: Program and abstracts of the 13th European AIDS Conference (Belgrade, Serbia). Paris, France: European AIDS Clinical Society, 2011.
27. Cuzin L, Trabelsi S, Mouillot GL, et al. ANRS 145 Marimuno Study: a multi-centre prospective pilot study evaluating intensification of stable antiviral therapy with maraviroc in HIV-1-infected patients with insufficient immune restoration despite persistently controlled viral replication [abstract PS1/6]. In: Program and abstracts of the 13th European AIDS Conference (Belgrade, Serbia). Paris France: European AIDS Clinical Society, 2011.
28. Lazzarin A, Sierra-Maderno JG, Battegay M, et al. Maraviroc increases CD4+ and CD8+ cells: long-term data from the maraviroc clinical development program [abstract 045]. Paper presented at: Tenth International Congress on Drug Therapy in HIV Infection (Glasgow, Scotland). J Int AIDS Soc 2010; 13:O45.
29. Bedimo RJ, McGinnis KA, Dunlap M, Rodriguez-Barradas MC, Justice AC. Incidence of non-AIDS-defining malignancies in HIV-infected versus noninfected patients in the HAART era: impact of immunosuppression. J Acquir Immune Defic Syndr 2009; 52:203-8.
30. Friis-Moller N, Sabin CA, Weber R, et al. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med 2003; 349:1993-2003.
31. Sackoff JE, Hanna DB, Pfeiffer MR, Torian LV. Causes of death among persons with AIDS in the era of highly active antiretroviral therapy: New York City. Ann Intern Med 2006; 145:397-406.
32. Long JL, Engels EA, Moore RD, Gebo KA. Incidence and outcomes of malignancy in the HAART era in an urban cohort of HIV-infected individuals. AIDS 2008; 22:489-96.
33. Marin B, Thiebaut R, Bucher HC, et al. Non-AIDS-defining deaths and immunodeficiency in the era of combination antiretroviral therapy. AIDS 2009; 23:1743-53.
34. Weber R, Sabin CA, Friis-Moller N, et al. Liver-related deaths in persons infected with the human immunodeficiency virus: the D:A:D study. Arch Intern Med 2006; 166:1632-41.
35. Giorgi JV, Hultin LE, McKeating JA, et al. Shorter survival in advanced human immunodeficiency virus type 1 infection is more closely associated with T lymphocyte activation than with plasma virus burden or virus chemokine coreceptor usage. J Infect Dis 1999; 179:859-70.