Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/13/2019 |
| Start Date: | December 1, 2008 |
| Contact: | Kathleen R Gittens |
| Email: | gittenskr@mail.nih.gov |
| Phone: | (301) 435-8003 |
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
NIAID s 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.
patients. The study will also serve as a means for recruiting HIV-infected individuals to
NIAID s 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.
This study is designed as a prospective natural history study with ongoing monitoring of HIV
infection and HIV-related disease processes. Minimal studies scheduled for each visit will
include: monitoring of immune status and viral load, routine safety laboratory tests, and
collection of blood for research and storage. Treatment plans will be in accordance with
standard medical practice, and the number and length of additional visits and diagnostic
evaluations will vary accordingly. Specific treatment regimens will be in accordance with
standard medical practice.
infection and HIV-related disease processes. Minimal studies scheduled for each visit will
include: monitoring of immune status and viral load, routine safety laboratory tests, and
collection of blood for research and storage. Treatment plans will be in accordance with
standard medical practice, and the number and length of additional visits and diagnostic
evaluations will vary accordingly. Specific treatment regimens will be in accordance with
standard medical practice.
- INCLUSION CRITERIA:
Patients are subject to selection by the Principal Investigator, and will satisfy all of
the following inclusion criteria:
1. 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.
2. Age 18 years or older.
3. Ability and willingness of subject to understand study requirements and give written
informed consent.
4. 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.
5. For Group I patients, residence within the greater Washington DC area (approximately
within a 100-mile radius of the NIH Bethesda campus) is required.
EXCLUSION CRITERIA:
A prospective study subject will be ineligible for this study if he or she satisfies either
of the following criteria:
1. Has active drug or alcohol use or dependence or any other condition that, in the
opinion of the investigator, would interfere with adherence to study requirements.
2. Refuses to allow collection and storage of samples for research purposes.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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