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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00789009
First received: November 8, 2008
Last updated: April 1, 2014
Last verified: March 2014
  Purpose

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.


Condition
HIV Infections
AIDS
Opportunistic Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 269
Study Start Date: November 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789009

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Michael C Sneller, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00789009     History of Changes
Other Study ID Numbers: 090030, 09-I-0030
Study First Received: November 8, 2008
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HIV
Natural History
Stored Sample
AIDS

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Opportunistic Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Infection
Parasitic Diseases

ClinicalTrials.gov processed this record on July 28, 2014