Multicenter AIDS Cohort Study (MACS)

HIV Infections Clinical Trial

Official title:

Multicenter AIDS Cohort Study (MACS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00046280
• Other study ID #: MACS
• Status: Active, not recruiting
• Start date: April 1984
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2019
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a comprehensive observational study of HIV infection in homosexual and bisexual men.

Description:

The Multicenter AIDS Cohort Study (MACS) provides important information about the changing nature of HIV-mediated disease progression, the impact of antiretroviral treatment, the nature of HIV pathogenesis, and viral and host genetic factors. This study will also assess the long-term patterns of therapy use and risk-taking behaviors.

Patients will have study visits every 6 months. The visits will include interviews, specimen collection, and a physical examination.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7087
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV negative, or

• HIV positive and no history or current use of highly active antiretroviral therapy (HAART), or

• HIV positive HAART recipient with documentation of HAART initiation, no AIDS diagnosis prior to HAART initiation, and a CD4 cell count and HIV-1 RNA measurement within 6 months prior to first HAART use.

• Sexual intercourse with men or at least 5 male or female partners in the 5 years prior to enrollment.

Exclusion Criteria:

• Injection drug use within 1 year of enrollment.

• Perinatally acquired HIV infection.

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Johns Hopkins School of Public Health	Baltimore	Maryland
United States	CORE Health Center	Chicago	Illinois
United States	Public Health Center	Los Angeles	California
United States	University of Pittsburgh School of Public Health	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (36)

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, Muñoz A, Greenblatt RM. Association of race and gender with HIV-1 RNA levels and immunologic progre — View Citation

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 u — View Citation

Cole SR, Hernán MA, Robins JM, Anastos K, Chmiel J, Detels R, Ervin C, Feldman J, Greenblatt R, Kingsley L, Lai S, Young M, Cohen M, Muñoz A. Effect of highly active antiretroviral therapy on time to acquired immunodeficiency syndrome or death using margi — View Citation

Detels R, Muñoz 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. JAM — View Citation

Detels R, Tarwater P, Phair JP, Margolick J, Riddler SA, Muñoz 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. — View Citation

Enger C, Graham N, Peng Y, Chmiel JS, Kingsley LA, Detels R, Muñoz A. Survival from early, intermediate, and late stages of HIV infection. JAMA. 1996 May 1;275(17):1329-34. — View Citation

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. — View Citation

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. — View Citation

Jacobson LP, Li R, Phair J, Margolick JB, Rinaldo CR, Detels R, Muñoz 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 Ep — View Citation

Kingsley LA, Zhou SY, Bacellar H, Rinaldo CR Jr, Chmiel J, Detels R, Saah A, VanRaden M, Ho M, Muñoz A. Temporal trends in human immunodeficiency virus type 1 seroconversion 1984-1989. A report from the Multicenter AIDS Cohort Study (MACS). Am J Epidemiol — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lyles RH, Muñoz 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 A — View Citation

Margolick JB, Muñoz 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. — View Citation

Mellors JW, Muñoz 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):946-5 — View Citation

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. — View Citation

Muñoz 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):4 — View Citation

Muñoz A, Sabin CA, Phillips AN. The incubation period of AIDS. AIDS. 1997;11 Suppl A:S69-76. Review. — View Citation

Muñoz 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. — View Citation

Phair JP, Mellors JW, Detels R, Margolick JB, Muñoz A. Virologic and immunologic values allowing safe deferral of antiretroviral therapy. AIDS. 2002 Dec 6;16(18):2455-9. — View Citation

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. — View Citation

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( — View Citation

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 — View Citation

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):5 — View Citation

Schneider MF, Gange SJ, Williams CM, Anastos K, Greenblatt RM, Kingsley L, Detels R, Muñoz 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. — View Citation

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. — View Citation

Silverberg MJ, Smith MW, Chmiel JS, Detels R, Margolick JB, Rinaldo CR, O'Brien SJ, Muñoz 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):2 — View Citation

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. — View Citation

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. — View Citation

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 (H — View Citation

Tarwater PM, Margolick JB, Jin J, Phair JP, Detels R, Rinaldo C, Giorgi J, Muñoz 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. — View Citation

Tarwater PM, Mellors J, Gore ME, Margolick JB, Phair J, Detels R, Muñoz 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. — View Citation

Thio CL, Seaberg EC, Skolasky R Jr, Phair J, Visscher B, Muñoz 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. — View Citation

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. — View Citation

Yamashita TE, Phair JP, Muñoz 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. — View Citation

* Note: There are 36 references in all — Click here to view all references

External Links

•   Click here for the MACS homepage.