Recruiting

NCT Number: NCT00789009

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 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.

Recruiting

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Opportunistic Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

About this study

This study is designed as a prospective natural history study with ongoing monitoring of HIV infection and HIV-related disease processes. The overall protocol Objective is to determine the long-term clinical outcome of treated HIV infection and investigate aspects of the host immune response that may predict outcomes. Minimal studies scheduled for each visit include: monitoring of immune status and viral load, routine safety laboratory tests, and collection of blood for research and storage. Medical treatment of HIV infection will be provided in accordance with standard medical practice. Specific HIV treatment regimens will be in accordance with standard medical practice and not constitute research.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA:

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.

Exclusion criteria

A prospective study subject will be ineligible for this study if he or she satisfies either of the following criteria:

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.
Refuses to allow collection and storage of samples for research purposes.

Treatment and study plan

Primary outcomes

This study will provide a clinically well-characterized cohort of HIV infected individuals to support ongoing clinical and laboratory based NIAID intramural research programs described above.

Time frame: Every 3 to 6 months

Laboratory results and clinical data

Secondary outcomes

This study will support the NIAID Infectious Disease training program by providing fellows with ongoing training in the management of HIV infection.

Time frame: Yearly

Training

Study contacts

Contact information is provided by the study sponsor or research team.

Bryan P Higgins, R.N.

CONTACT

[email protected]

(301) 761-7395

Michael C Sneller, M.D.

CONTACT

[email protected]

(301) 496-0491

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Important dates

Study start: 2008
First posted: Nov 11, 2008
Registry last updated: Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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