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Multicenter AIDS Cohort Study (MACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00046280
Recruitment Status : Active, not recruiting
First Posted : September 26, 2002
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a comprehensive observational study of HIV infection in homosexual and bisexual men.

Condition or disease
HIV Infections

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

Study Type : Observational
Estimated Enrollment : 7087 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter AIDS Cohort Study (MACS)
Study Start Date : April 1984
Estimated Primary Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples With DNA
Blood serum, plasma, and cells

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Homosexual and bisexual men with and without HIV infection
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00046280


Locations
United States, California
Public Health Center
Los Angeles, California, United States
United States, Illinois
CORE Health Center
Chicago, Illinois, United States
United States, Maryland
Johns Hopkins School of Public Health
Baltimore, Maryland, United States
United States, Pennsylvania
University of Pittsburgh School of Public Health
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Additional Information:
Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00046280     History of Changes
Other Study ID Numbers: MACS
First Posted: September 26, 2002    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases