Clinical trial NCT00046280: Multicenter AIDS Cohort Study (MACS)
Official title: Multicenter AIDS Cohort Study (MACS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2002-09-26
Enrollment: 7087
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Homosexual and bisexual men with and without HIV infection

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Public Health Center
state: California
city: Chicago
country: United States
facility: CORE Health Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins School of Public Health
state: Maryland
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Public Health
state: Pennsylvania
Study officials:
References:
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