Monitoring HIV infection and related conditions in patients

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

This study is looking to track the health of people with known or suspected HIV over time to see how the disease progresses and to help improve treatment options.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00789009 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with known or suspected HIV infection, aiming to monitor their health and the progression of the disease over time. Participants will undergo evaluations every 3 to 4 months, including physical exams, blood tests for immune status and viral load, and other necessary procedures. The study also serves to recruit HIV-infected individuals for ongoing clinical and laboratory studies at the NIAID and to provide training for Infectious Disease fellows in managing HIV. The goal is to understand the long-term clinical outcomes of treated HIV infection and the host immune responses that may influence these outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 and older with confirmed or suspected HIV infection residing in the Washington, D.C. metropolitan area.

Not a fit: Patients who do not have HIV infection or who live outside the specified geographic area may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of HIV management and improve treatment strategies for patients.

How similar studies have performed: Other studies focusing on the natural history of HIV have shown success in understanding disease progression and treatment outcomes, making this approach well-supported in the field.

Eligibility 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Michael C Sneller, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Bryan P Higgins, R.N.

Conditions HIV; Opportunistic Infections; AIDS; Natural History