Infection with HIV (the virus that causes AIDS) can lead to problems with brain function,
such as memory, concentration, judgment, and the speed or control of hands and legs.
Neurologists have called this condition HIV-associated neurocognitive disorder (HAND). This
research is being done to see if insulin taken through the nose as a spray (intranasal
insulin) can help people with HIV who are having problems with memory and brain function, or
HAND.
Participants will be given either insulin or placebo. A placebo is an inactive substance that
looks like the study drug, but does not contain study drug. For this research study, the
placebo will be a clear, saline-based liquid spray that looks like the insulin spray but has
no insulin. Participants will not be told whether they receive insulin or placebo during the
study.
All participants will take the intranasal spray twice a day, about 30 minutes after a meal.
Participants will use a specialized intranasal drug administration device. The total daily
dose of insulin is 40 IU split between 20 IU in the morning and 20 IU in the evening.
Participants will take the intranasal spray for 24 weeks.
The researchers will record symptoms and side effects during the study. Procedures include
neurocognitive testing of memory and brain function, two optional lumbar punctures ("spinal
taps"), two MRI brain scans, monthly blood draws, and clinical assessments.