Completed
Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2016-11-07
N/A
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients. 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.
CONDITIONS
Official Title
A Study of HIV in Newly Infected Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Patients must have:
- 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
Co-existing Condition:
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 12 locations
1
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
2
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States, 94102
Status Unknown
3
Denver Dept of Public Health / HIVNET
Denver, Colorado, United States, 80204
Status Unknown
4
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, United States, 60612
Status Unknown
5
Johns Hopkins Univ
Baltimore, Maryland, United States, 21205
Status Unknown
6
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, United States, 02115
Status Unknown
7
New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
8
Bronx-Lebanon Hosp Ctr
The Bronx, New York, United States, 10453
Status Unknown
9
New York Blood Ctr
The Bronx, New York, United States, 10456
Status Unknown
10
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
11
Miriam Hosp
Providence, Rhode Island, United States, 02906
Status Unknown
12
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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