NCT00789009 · National Institute of Allergy and Infectious Diseases (NIAID)
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Bethesda, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations