Multicenter AIDS-kohortestudie (MACS)
17. juli 2019 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)
Dette er en omfattende observationsundersøgelse af HIV-infektion hos homoseksuelle og biseksuelle mænd.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Multicenter AIDS Cohort Study (MACS) giver vigtig information om den skiftende karakter af HIV-medieret sygdomsprogression, virkningen af antiretroviral behandling, arten af HIV-patogenese og virus- og værtsgenetiske faktorer. Denne undersøgelse vil også vurdere de langsigtede mønstre for terapibrug og risikoadfærd.
Patienterne vil have studiebesøg hver 6. måned. Besøgene vil omfatte interviews, prøveindsamling og en fysisk undersøgelse.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
7087
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Angeles, California, Forenede Stater
- Public Health Center
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Illinois
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Chicago, Illinois, Forenede Stater
- CORE Health Center
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Maryland
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Baltimore, Maryland, Forenede Stater
- Johns Hopkins School of Public Health
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater
- University of Pittsburgh School of Public Health
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Homoseksuelle og biseksuelle mænd med og uden HIV-infektion
Beskrivelse
Inklusionskriterier:
- HIV-negativ, eller
- HIV-positiv og ingen historie eller aktuel brug af højaktiv antiretroviral terapi (HAART), eller
- HIV-positiv HAART-modtager med dokumentation for HAART-initiering, ingen AIDS-diagnose før HAART-initiering og et CD4-celletal og HIV-1 RNA-måling inden for 6 måneder før første brug af HAART.
- Seksuelt samleje med mænd eller mindst 5 mandlige eller kvindelige partnere i de 5 år forud for tilmeldingen.
Ekskluderingskriterier:
- Injektionsbrug inden for 1 år efter tilmelding.
- Perinatalt erhvervet HIV-infektion.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Williams CF, Klinzman D, Yamashita TE, Xiang J, Polgreen PM, Rinaldo C, Liu C, Phair J, Margolick JB, Zdunek D, Hess G, Stapleton JT. Persistent GB virus C infection and survival in HIV-infected men. N Engl J Med. 2004 Mar 4;350(10):981-90. doi: 10.1056/NEJMoa030107.
- Kingsley LA, Zhou SY, Bacellar H, Rinaldo CR Jr, Chmiel J, Detels R, Saah A, VanRaden M, Ho M, Munoz A. Temporal trends in human immunodeficiency virus type 1 seroconversion 1984-1989. A report from the Multicenter AIDS Cohort Study (MACS). Am J Epidemiol. 1991 Aug 15;134(4):331-9. doi: 10.1093/oxfordjournals.aje.a116094.
- Margolick JB, Munoz A, Donnenberg AD, Park LP, Galai N, Giorgi JV, O'Gorman MR, Ferbas J. Failure of T-cell homeostasis preceding AIDS in HIV-1 infection. The Multicenter AIDS Cohort Study. Nat Med. 1995 Jul;1(7):674-80. doi: 10.1038/nm0795-674.
- Jacobson LP, Kirby AJ, Polk S, Phair JP, Besley DR, Saah AJ, Kingsley LA, Schrager LK. Changes in survival after acquired immunodeficiency syndrome (AIDS): 1984-1991. Am J Epidemiol. 1993 Dec 1;138(11):952-64. doi: 10.1093/oxfordjournals.aje.a116815.
- Munoz A, Xu J. Models for the incubation of AIDS and variations according to age and period. Stat Med. 1996 Nov 15-30;15(21-22):2459-73. doi: 10.1002/(sici)1097-0258(19961130)15:223.0.co;2-q.
- Enger C, Graham N, Peng Y, Chmiel JS, Kingsley LA, Detels R, Munoz A. Survival from early, intermediate, and late stages of HIV infection. JAMA. 1996 May 1;275(17):1329-34.
- Munoz A, Sabin CA, Phillips AN. The incubation period of AIDS. AIDS. 1997;11 Suppl A:S69-76. No abstract available.
- Mellors JW, Munoz A, Giorgi JV, Margolick JB, Tassoni CJ, Gupta P, Kingsley LA, Todd JA, Saah AJ, Detels R, Phair JP, Rinaldo CR Jr. Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med. 1997 Jun 15;126(12):946-54. doi: 10.7326/0003-4819-126-12-199706150-00003.
- Lyles RH, Munoz A, Yamashita TE, Bazmi H, Detels R, Rinaldo CR, Margolick JB, Phair JP, Mellors JW. Natural history of human immunodeficiency virus type 1 viremia after seroconversion and proximal to AIDS in a large cohort of homosexual men. Multicenter AIDS Cohort Study. J Infect Dis. 2000 Mar;181(3):872-80. doi: 10.1086/315339.
- Detels R, Tarwater P, Phair JP, Margolick J, Riddler SA, Munoz A; Multicenter AIDS Cohort Study. Effectiveness of potent antiretroviral therapies on the incidence of opportunistic infections before and after AIDS diagnosis. AIDS. 2001 Feb 16;15(3):347-55. doi: 10.1097/00002030-200102160-00008.
- Tarwater PM, Mellors J, Gore ME, Margolick JB, Phair J, Detels R, Munoz A. Methods to assess population effectiveness of therapies in human immunodeficiency virus incident and prevalent cohorts. Am J Epidemiol. 2001 Oct 1;154(7):675-81. doi: 10.1093/aje/154.7.675.
- Detels R, Munoz A, McFarlane G, Kingsley LA, Margolick JB, Giorgi J, Schrager LK, Phair JP. Effectiveness of potent antiretroviral therapy on time to AIDS and death in men with known HIV infection duration. Multicenter AIDS Cohort Study Investigators. JAMA. 1998 Nov 4;280(17):1497-503. doi: 10.1001/jama.280.17.1497.
- Yamashita TE, Phair JP, Munoz A, Margolick JB, Detels R, O'Brien SJ, Mellors JW, Wolinsky SM, Jacobson LP. Immunologic and virologic response to highly active antiretroviral therapy in the Multicenter AIDS Cohort Study. AIDS. 2001 Apr 13;15(6):735-46. doi: 10.1097/00002030-200104130-00009.
- Tarwater PM, Margolick JB, Jin J, Phair JP, Detels R, Rinaldo C, Giorgi J, Munoz A. Increase and plateau of CD4 T-cell counts in the 3(1/2) years after initiation of potent antiretroviral therapy. J Acquir Immune Defic Syndr. 2001 Jun 1;27(2):168-75. doi: 10.1097/00126334-200106010-00012.
- Kleeberger CA, Phair JP, Strathdee SA, Detels R, Kingsley L, Jacobson LP. Determinants of heterogeneous adherence to HIV-antiretroviral therapies in the Multicenter AIDS Cohort Study. J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):82-92. doi: 10.1097/00126334-200101010-00012.
- Sacktor N, Lyles RH, Skolasky R, Kleeberger C, Selnes OA, Miller EN, Becker JT, Cohen B, McArthur JC; Multicenter AIDS Cohort Study. HIV-associated neurologic disease incidence changes:: Multicenter AIDS Cohort Study, 1990-1998. Neurology. 2001 Jan 23;56(2):257-60. doi: 10.1212/wnl.56.2.257.
- Jacobson LP, Li R, Phair J, Margolick JB, Rinaldo CR, Detels R, Munoz A. Evaluation of the effectiveness of highly active antiretroviral therapy in persons with human immunodeficiency virus using biomarker-based equivalence of disease progression. Am J Epidemiol. 2002 Apr 15;155(8):760-70. doi: 10.1093/aje/155.8.760.
- Munoz A, Kirby AJ, He YD, Margolick JB, Visscher BR, Rinaldo CR, Kaslow RA, Phair JP. Long-term survivors with HIV-1 infection: incubation period and longitudinal patterns of CD4+ lymphocytes. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Apr 15;8(5):496-505. doi: 10.1097/00042560-199504120-00010.
- Phair JP, Mellors JW, Detels R, Margolick JB, Munoz A. Virologic and immunologic values allowing safe deferral of antiretroviral therapy. AIDS. 2002 Dec 6;16(18):2455-9. doi: 10.1097/00002030-200212060-00011.
- Anastos K, Gange SJ, Lau B, Weiser B, Detels R, Giorgi JV, Margolick JB, Cohen M, Phair J, Melnick S, Rinaldo CR, Kovacs A, Levine A, Landesman S, Young M, Munoz A, Greenblatt RM. Association of race and gender with HIV-1 RNA levels and immunologic progression. J Acquir Immune Defic Syndr. 2000 Jul 1;24(3):218-26. doi: 10.1097/00126334-200007010-00004.
- Silverberg MJ, Smith MW, Chmiel JS, Detels R, Margolick JB, Rinaldo CR, O'Brien SJ, Munoz A. Fraction of cases of acquired immunodeficiency syndrome prevented by the interactions of identified restriction gene variants. Am J Epidemiol. 2004 Feb 1;159(3):232-41. doi: 10.1093/aje/kwh036.
- Riddler SA, Smit E, Cole SR, Li R, Chmiel JS, Dobs A, Palella F, Visscher B, Evans R, Kingsley LA. Impact of HIV infection and HAART on serum lipids in men. JAMA. 2003 Jun 11;289(22):2978-82. doi: 10.1001/jama.289.22.2978.
- Cole SR, Hernan MA, Robins JM, Anastos K, Chmiel J, Detels R, Ervin C, Feldman J, Greenblatt R, Kingsley L, Lai S, Young M, Cohen M, Munoz A. Effect of highly active antiretroviral therapy on time to acquired immunodeficiency syndrome or death using marginal structural models. Am J Epidemiol. 2003 Oct 1;158(7):687-94. doi: 10.1093/aje/kwg206.
- Sacktor N, Skolasky RL, Tarwater PM, McArthur JC, Selnes OA, Becker J, Cohen B, Visscher B, Miller EN; Multicenter AIDS Cohort Study (MACS). Response to systemic HIV viral load suppression correlates with psychomotor speed performance. Neurology. 2003 Aug 26;61(4):567-9. doi: 10.1212/01.wnl.0000076477.71313.6e.
- Farinpour R, Miller EN, Satz P, Selnes OA, Cohen BA, Becker JT, Skolasky RL Jr, Visscher BR. Psychosocial risk factors of HIV morbidity and mortality: findings from the Multicenter AIDS Cohort Study (MACS). J Clin Exp Neuropsychol. 2003 Aug;25(5):654-70. doi: 10.1076/jcen.25.5.654.14577.
- Thio CL, Seaberg EC, Skolasky R Jr, Phair J, Visscher B, Munoz A, Thomas DL; Multicenter AIDS Cohort Study. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet. 2002 Dec 14;360(9349):1921-6. doi: 10.1016/s0140-6736(02)11913-1.
- Seage GR 3rd, Losina E, Goldie SJ, Paltiel AD, Kimmel AD, Freedberg KA. The relationship of preventable opportunistic infections, HIV-1 RNA, and CD4 Cell counts to chronic mortality. J Acquir Immune Defic Syndr. 2002 Aug 1;30(4):421-8. doi: 10.1097/00042560-200208010-00008.
- Tam HK, Zhang ZF, Jacobson LP, Margolick JB, Chmiel JS, Rinaldo C, Detels R. Effect of highly active antiretroviral therapy on survival among HIV-infected men with Kaposi sarcoma or non-Hodgkin lymphoma. Int J Cancer. 2002 Apr 20;98(6):916-22. doi: 10.1002/ijc.10274.
- Tang J, Shelton B, Makhatadze NJ, Zhang Y, Schaen M, Louie LG, Goedert JJ, Seaberg EC, Margolick JB, Mellors J, Kaslow RA. Distribution of chemokine receptor CCR2 and CCR5 genotypes and their relative contribution to human immunodeficiency virus type 1 (HIV-1) seroconversion, early HIV-1 RNA concentration in plasma, and later disease progression. J Virol. 2002 Jan;76(2):662-72. doi: 10.1128/jvi.76.2.662-672.2002.
- Skolasky RL, Phair J, Detels R, Riddler S, Margolick J, Jacobson LP. Thrush and fever as markers of immune competence in the era of highly active antiretroviral therapy. AIDS Res Hum Retroviruses. 2001 Sep 20;17(14):1311-6. doi: 10.1089/08892220152596551.
- Sacktor N, Tarwater PM, Skolasky RL, McArthur JC, Selnes OA, Becker J, Cohen B, Miller EN; Multicenter for AIDS Cohort Study (MACS). CSF antiretroviral drug penetrance and the treatment of HIV-associated psychomotor slowing. Neurology. 2001 Aug 14;57(3):542-4. doi: 10.1212/wnl.57.3.542.
- Lau B, Gange SJ, Phair JP, Riddler SA, Detels R, Margolick JB. Use of total lymphocyte count and hemoglobin concentration for monitoring progression of HIV infection. J Acquir Immune Defic Syndr. 2005 Aug 15;39(5):620-5.
- Chu H, Gange SJ, Yamashita TE, Hoover DR, Chmiel JS, Margolick JB, Jacobson LP. Individual variation in CD4 cell count trajectory among human immunodeficiency virus-infected men and women on long-term highly active antiretroviral therapy: an application using a Bayesian random change-point model. Am J Epidemiol. 2005 Oct 15;162(8):787-97. doi: 10.1093/aje/kwi268. Epub 2005 Aug 31.
- Li X, Margolick JB, Conover CS, Badri S, Riddler SA, Witt MD, Jacobson LP. Interruption and discontinuation of highly active antiretroviral therapy in the multicenter AIDS cohort study. J Acquir Immune Defic Syndr. 2005 Mar 1;38(3):320-8.
- Schneider MF, Gange SJ, Williams CM, Anastos K, Greenblatt RM, Kingsley L, Detels R, Munoz A. Patterns of the hazard of death after AIDS through the evolution of antiretroviral therapy: 1984-2004. AIDS. 2005 Nov 18;19(17):2009-18. doi: 10.1097/01.aids.0000189864.90053.22.
- Modi WS, Scott K, Goedert JJ, Vlahov D, Buchbinder S, Detels R, Donfield S, O'brien SJ, Winkler C. Haplotype analysis of the SDF-1 (CXCL12) gene in a longitudinal HIV-1/AIDS cohort study. Genes Immun. 2005 Dec;6(8):691-8. doi: 10.1038/sj.gene.6364258.
- Minhas AS, Post WS, Liu B, Doria De Vasconcellos H, Haberlen SA, Feinstein M, Stosor V, Budoff M, Chew KW, Magnani JW, Brown T, Lima JAC, Wu KC. Association of HIV Serostatus and Inflammation With Ascending Aortic Size. J Am Heart Assoc. 2022 Mar 15;11(6):e023997. doi: 10.1161/JAHA.121.023997. Epub 2022 Mar 5.
- Haley DF, Edmonds A, Ramirez C, French AL, Tien P, Thio CL, Witt MD, Seaberg EC, Plankey MW, Cohen MH, Adimora AA. Direct-Acting Antiviral Hepatitis C Treatment Cascade and Barriers to Treatment Initiation Among US Men and Women With and Without HIV. J Infect Dis. 2021 Jun 15;223(12):2136-2144. doi: 10.1093/infdis/jiaa686.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 1984
Primær færdiggørelse (Forventet)
30. april 2020
Studieafslutning (Forventet)
30. april 2020
Datoer for studieregistrering
Først indsendt
24. september 2002
Først indsendt, der opfyldte QC-kriterier
25. september 2002
Først opslået (Skøn)
26. september 2002
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MACS
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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