HIV InfectionsNCT00046280
Multicenter AIDS Cohort Study (MACS)
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
This is a comprehensive observational study of HIV infection in homosexual and bisexual men. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 7,087 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 1984to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Homosexual and bisexual men with and without HIV infection
Who may be able to join
- 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.
Who cannot join
- Injection drug use within 1 year of enrollment.
- Perinatally acquired HIV infection.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins School of Public Health
Baltimore, Maryland
CORE Health Center
Chicago, Illinois
Public Health Center
Los Angeles, California
University of Pittsburgh School of Public Health
Pittsburgh, Pennsylvania
About this study
This is a comprehensive observational study of HIV infection in homosexual and bisexual men.
Read the detailed 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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2002 (estimated)
- Study startApr 1984
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,087 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046280
- Sponsor's protocol ID
- MACS
- Status last verified
- Jul 2019
- First submitted
- 24 Sep 2002
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 14999110Kingsley 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.
PubMed 1877593Margolick 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.
PubMed 7585150Jacobson 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.
PubMed 7903022Munoz 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.
PubMed 8931213Enger 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.
PubMed 8614118Munoz A, Sabin CA, Phillips AN. The incubation period of AIDS. AIDS. 1997;11 Suppl A:S69-76. No abstract available.
PubMed 9451969Mellors 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.
PubMed 9182471Lyles 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.
PubMed 10720507Detels 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.
PubMed 11273215Tarwater 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.
PubMed 11581102Detels 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.
PubMed 9809730Yamashita 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.
PubMed 11371688Tarwater 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.
PubMed 11404539Kleeberger 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.
PubMed 11176272
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter AIDS Cohort Study (MACS)
- ClinicalTrials.gov ID
- NCT00046280
- Acronym / sponsor ID
- MACS
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,087 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 1984
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 26 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a comprehensive observational study of HIV infection in homosexual and bisexual men.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Homosexual and bisexual men with and without HIV infection
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Injection drug use within 1 year of enrollment.
- Perinatally acquired HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Results publication: PubMed 14999110Williams 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.
- Results publication: PubMed 1877593Kingsley 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.
- Results publication: PubMed 7585150Margolick 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.
- Results publication: PubMed 7903022Jacobson 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.
- Results publication: PubMed 8931213Munoz 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.
- Results publication: PubMed 8614118Enger 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.
- Results publication: PubMed 9451969Munoz A, Sabin CA, Phillips AN. The incubation period of AIDS. AIDS. 1997;11 Suppl A:S69-76. No abstract available.
- Results publication: PubMed 9182471Mellors 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.
- Results publication: PubMed 10720507Lyles 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.
- Results publication: PubMed 11273215Detels 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.
- Results publication: PubMed 11581102Tarwater 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.
- Results publication: PubMed 9809730Detels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00046280, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.