Recruiting

HIV Infection

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT00789009

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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 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.

Conditions

HIV

Study ID

NCT00789009

Start date

Nov 20, 2008

Status verified date

Mar 3, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Consist of HIV positive patients recruited from the Washington DC metropolitan area who will receive long-term care for their HIV infection through the NIAID/CCMD HIV clinic

Group 2

Patients with known or suspected HIV infection, referred to a NIAID/CCMD investigator for reasons such as testing to diagnose or exclude HIV disease or assistance with HIV-related problems.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Aug 27, 2026

Last verified

Mar 3, 2026

Keywords

  • Opportunistic Infections
  • AIDS
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-08-27.