Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection. People 18 years of age and older with suspected or confirmed HIV infection who live in the Washington, D.C., metropolitan area may be eligible for this study. Physician referral is required. Participants come to the NIH Clinical Center a minimum of once every 3 to 4 months for evaluation with a physical examination; blood tests for research purposes, safety, immune status and viral load; and response to any treatment they may be receiving. Other procedures, such as a biopsy, are done only as needed for standard medical practice, and informed consent is obtained before any such procedure is done. Treatment offered is consistent with standard medical practice; no experimental treatments are offered under this protocol. ...

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patients are subject to selection by the Principal Investigator, and will satisfy all of the following inclusion criteria:

• HIV-infection as documented by positive HIV ELISA and Western Blot or positive assay for HIV RNA (serum or plasma). Patients may also be included if they have laboratory or clinical evidence suggestive of possible HIV-infection.

• Age 18 years or older.

• Ability and willingness of subject to understand study requirements and give written informed consent.

• Group I patients are required to have a primary care provider outside NIH to manage non-HIV medical problems. Group II patients must have a referring physician or clinic that will continue to manage HIV and non-HIV medical care.

• For Group I patients, residence within the greater Washington DC area (approximately within a 100-mile radius of the NIH Bethesda campus) is required.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Bryan P Higgins, R.N.
bryan.higgins@nih.gov
(301) 761-7395
Backup
Michael C Sneller, M.D.
msneller@niaid.nih.gov
(301) 496-0491
Time Frame
Start Date: 2008-11-20
Participants
Target number of participants: 600
Treatments
Group 1
Consist of HIV positive patients recruited from the Washington DC metropolitan area who will receive long-term care for their HIV infection through the NIAID/CCMD HIV clinic
Group 2
Patients with known or suspected HIV infection, referred to a NIAID/CCMD investigator for reasons such as testing to diagnose or exclude HIV disease or assistance with HIV-related problems.
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov