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

November 8, 2008
April 1, 2014
November 2008
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Complete list of historical versions of study NCT00789009 on ClinicalTrials.gov Archive Site
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Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection

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.

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.

Observational
Time Perspective: Prospective
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  • HIV Infections
  • AIDS
  • Opportunistic Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
269
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  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00789009
090030, 09-I-0030
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Michael C Sneller, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP