Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
OBSERVATIONAL
2008-05-31
Brief Summary
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Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.
Detailed Description
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This study consists of two parts. Part A includes HIV-infected patients who enrolled in HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been closely monitored and characterized. This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. Part B includes newly HIV-infected patients. These patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through Year 5.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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A
HIV-infected individuals enrolled in HIVNET D01
No interventions assigned to this group
B
Individuals with newly acquired HIV infection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* HIV infection, as documented by enrollment in HIVNET D01.1 (Part A patients) or by standard HIV serological tests or demonstrated HIV infection on virologic assay (Part B patients).
Part A only:
* Previous enrollment in infected-participants cohort of HIVNET D01.
Part B only:
* Initial HIV-seronegativity on an HIVNET protocol (other than an HIV vaccine protocol) and testing positive for HIV at a subsequent clinic visit.
* Confirmation of HIV infection and documentation of HIV negative antibody test within 8 months of first positive test.
Exclusion Criteria
Patients with the following conditions are excluded:
* An obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study.
Prior Medication:
Excluded:
* Participation in a HIVNET HIV vaccine trial.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Celum C
Role: STUDY_CHAIR
Buchbinder S
Role: STUDY_CHAIR
Sheppard H
Role: STUDY_CHAIR
Locations
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Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, United States
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States
Denver Dept of Public Health / HIVNET
Denver, Colorado, United States
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, United States
Johns Hopkins Univ
Baltimore, Maryland, United States
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, United States
New York Univ Med Ctr
New York, New York, United States
Bronx-Lebanon Hosp Ctr
The Bronx, New York, United States
New York Blood Ctr
The Bronx, New York, United States
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, United States
Miriam Hosp
Providence, Rhode Island, United States
Univ of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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HIVNET 019
Identifier Type: -
Identifier Source: org_study_id