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HIV Infection in Homosexual and Bisexual Men

This study is ongoing, but not recruiting participants.
Study NCT00046280.   Last updated on August 7, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  HIV Infection in Homosexual and Bisexual Men
Official Title 
Brief Summary

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 Phase
Study Type  Observational
Study Design  Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention 
MEDLINE PMIDs 14999110,   1877593,   7585150,   7903022,   8931213,   8614118,   9451969,   9182471,   10720507,   11273215,   11581102,   9809730,   11371688,   11404539,   11176272,   11160967,   11943695,   7697447,   12461420,   10969345,   14742283,   12799406,   14507605,   12939443,   12815503,   12493258,   12138349,   11948473,   11752157,   11602040,   11502933,   16044017,   16135508,   15735452,   15405677,   16260908,   16177829
Links Click here for the MACS homepage. This link exits the ClinicalTrials.gov site
Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  1100
Start Date 
Completion Date
Eligibility 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.
Gender Male
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00046280
Organization ID MACS
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date November 2005
First Received Date  September 24, 2002
Last Updated Date August 7, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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