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

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ClinicalTrials.gov Identifier: NCT00789009
Recruitment Status : Recruiting
First Posted : November 11, 2008
Last Update Posted : December 28, 2017
Information provided by (Responsible Party):

Study Description
Brief 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 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 or disease
HIV Infections AIDS Opportunistic Infections

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.

Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Time Perspective: Prospective
Official Title: Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
Study Start Date : December 1, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789009

Contact: Gabriella M Diaz, R.N. (240) 669-5589 diazgm@mail.nih.gov
Contact: Michael C Sneller, M.D. (301) 496-0491 msneller@niaid.nih.gov

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Michael C Sneller, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00789009     History of Changes
Other Study ID Numbers: 090030
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 15, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Natural History
Stored Sample

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