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Multicenter AIDS Cohort Study (MACS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00046280
First received: September 24, 2002
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
This is a comprehensive observational study of HIV infection in homosexual and bisexual men.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter AIDS Cohort Study (MACS)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Estimated Enrollment: 7087
Study Start Date: April 1984
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 24, 2002
Last Updated: April 7, 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

ClinicalTrials.gov processed this record on July 19, 2017