HIV and AIDS Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people with HIV who have not recently been on treatment (ART-Naive Arm):

• People who have a confirmed HIV-1 diagnosis (records from other medical facilities are accepted)
• People who have not been on combination HIV treatment in the past two years (those with very limited recent use of 2–3 weeks or less may still be considered, at the investigator's discretion)
• People whose CD4+ cell count (an immune system measure) was 100 cells/mm³ or lower within the past 8 weeks
• People who live within 100 miles of the NIH Bethesda campus in the Washington D.C. area, and who plan to remain in that area for 48 weeks
• Men or women aged 18 or older
• People who are able and willing to understand the study requirements and provide consent (or have a legal guardian who can do so on their behalf)
• People willing to allow blood or tissue samples to be stored for future research
• People willing to undergo study procedures including blood draws, a blood cell collection process (apheresis), and optionally a PET/CT scan and lymph node biopsy
• People willing to have genetic testing done
• People who already have a primary care doctor, or who agree to have one arranged by 24 weeks into the study

For people who may be experiencing a condition called IRIS (Immune Reconstitution Inflammatory Syndrome Arm):

• People who have a confirmed HIV-1 diagnosis (records from other medical facilities are accepted)
• People who meet at least 4 out of 5 specific criteria suggesting IRIS — this includes recently starting, restarting, or changing HIV treatment; showing signs of immune recovery (such as a rise in CD4+ count or a drop in viral load); having symptoms of an infectious or inflammatory condition; those symptoms not being fully explained by a new infection, an expected illness course, or side effects of HIV treatment; and the condition being linked to a specific identified cause (confirm with trial site for full details)
• People who live within 100 miles of the NIH Bethesda campus (those living further away may be considered case by case)
• Men or women aged 18 or older
• People who are able and willing to understand the study requirements and provide consent
• People willing to allow blood or tissue samples to be stored for future research
• People willing to undergo study procedures including blood draws, apheresis, and optionally a PET/CT scan and lymph node biopsy
• People willing to have genetic testing done
• People who have a primary care doctor who will make the referral to the study

Who may not be able to join:

• People whose drug or alcohol use, in the study team's opinion, would make it difficult to follow the study requirements
• People who are currently pregnant, due to the intensive nature of the study procedures (blood draws, apheresis, biopsies, and PET/CT imaging)
• People whose veins are assessed by the study team as not suitable for the required blood draws and apheresis procedures
• People who are currently breastfeeding
• People with a life-threatening illness that the study team determines needs immediate medical treatment before study participation could be considered
• People whose inability to give consent is considered by the study team to be permanent
• People with a significant history of not following medical instructions, which the investigator believes would interfere with taking part in the study

Important: Always verify eligibility with the trial site directly before applying.