HIV and AIDS Trial, Recruiting NCT01875588 Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Condition: HIV and AIDS
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HIV and AIDS Trial, Recruiting

NCT01875588
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older.
  • People who are able to read, understand, and sign a consent form on their own.
  • People who have completed at least a seventh-grade level of education and can speak, read, and understand English — either as a native English speaker or as someone born overseas who can demonstrate English understanding at the time of testing.
  • People who agree to have blood and tissue samples stored for research.
  • People who are willing to take part in this study for up to 20 years.

For people living with HIV only:

  • People who have a confirmed HIV-1 diagnosis based on approved testing methods used by the study laboratory.
  • People who have a regular doctor outside of the study who provides their ongoing HIV care.
  • People whose HIV viral load (the amount of virus in the blood) has been undetectable or below 50 copies for more than one year, including those who may have had brief, isolated rises above that level surrounded by undetectable results.
  • People who have been on continuous HIV treatment (antiretroviral therapy) for at least one year.

For HIV-negative participants only:

  • People who test negative for HIV antibodies, including those who may be taking pre-exposure prevention medication (PrEP).

Who may not be able to join:

  • People who have a current illness or health condition that, in the opinion of the study doctor, may interfere with participation — this includes active brain infections such as certain viral brain infections, brain lymphoma, or toxoplasmosis. People who have fully recovered from a treated brain infection and returned to their normal daily activities may be considered (confirm with trial site).
  • People who have had other serious infections not involving the brain, unless they have fully recovered and returned to their normal activity level.
  • People who have conditions unrelated to HIV that affect thinking or memory, such as Alzheimer's disease, Parkinson's disease, a head injury involving more than 30 minutes of unconsciousness, untreated sleep apnoea with daytime sleepiness, or a seizure disorder — although people with a seizure history who have had no seizures and have been on a stable, non-sedating medication for more than six months may be considered.
  • People with severe or unstable mental health conditions that, in the opinion of the study team, may affect participation or make results harder to interpret. People who are stable on psychiatric medications for at least six months may be considered.
  • People with active substance misuse, including illegal drug use or excessive alcohol or narcotic use, that the study team believes may interfere with participation or results. Tobacco use is not an exclusion.
  • People who cannot safely have an MRI scan due to implanted metal devices such as pacemakers, brain stimulators, certain dental implants, aneurysm clips, metal prostheses, cochlear implants, an implanted drug pump, or shrapnel. People with mild to moderate claustrophobia who are able to take a low-dose oral sedative may still be considered. People who could be pregnant must have a negative pregnancy test within 48 hours before any MRI.
  • People who are taking certain medications — including narcotics, most psychiatric medications, and anti-seizure drugs — except under specific conditions described above. People must also be willing to avoid certain medications known to affect alertness or memory (such as sedating antihistamines or sleep aids) within 48 hours before cognitive testing.
  • People whose total radiation exposure from this study, combined with other medical care or research studies, would exceed the recommended safe yearly limit.
  • People who are pregnant, due to exposure to strong magnetic fields and potential radiation from certain procedures. A negative pregnancy test is required within 48 hours before any procedure involving radiation exposure.

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Avindra Nath, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Phone: (301) 538-9531

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
8 July 2013
Est. completion
22 February 2037

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To characterize in detail the natural course of HAND in subjects with prolonged plasma HIV virologic suppression (<50 copies/mL).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov