Neuro-AIDS Program

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Clinical Trials

Participating in Mount Sinai’s clinical trials allows you to take advantage of innovative treatments as we work together to advance the future of medicine.

Trials for HIV-Associated Dementia

This Trial is closed to enrollment

Memantine (GCO #86-037CM(104)IRB Approved through 12/31/00)If you are HIV+ and have difficulty thinking, remembering , or concentrating OR you have been diagnoseed with AIDS Dementia Complex, you may be interested in participating in a trail studying Memantine. Memantine is a drug that works through a novel mechanism of blocking oin channels and has promise in the treatment of AIDS dementia.

This trial is free of charge. You will not be reimbursed for travel expenses.

If you qualify for the study, you will receive either placebo or actual medication for 16 weeks. After a 4-week washout, you will be given the option of continuing with active treatment for 48 weeks.

Inclusion Criteria

  • On a stable antiretroviral drug regimen for at least 8 week

Trials for HIV-Associated Neuropathy

HIV infection is associated with painful sensory neuropathy. If you have been diagnosed with HIV-associated neuropathy or have experienced pain, numbness, or burning in your feet and/or hands, you might consider participating in one of these clinical trials.

Lamictal/Lamotrigine (GCO #99-622 NE IRB Approved through 8/14/00): The objective of this study is to assess the effectiveness and safety of Lamotrigine in relieving pain in patients with HIV-associated peripheral neuropathy.

Reports and data from previous clinical trials suggest a significant reduction in pain, and Lamotrigine has been shown safe with no serious side effects.

If you qualify for the study, you will receive either placebo or actual medication for 12 weeks. After the 12 weeks, you will be given the option of continuing with active treatment for another 5 months.

Should you agree to participate in this trial, you will be provided with study drug at no cost to you. This study is free of charge.

Inclusion Criteria

  • Are HIV+
  • Have painful peripheral neuropathy

Exclusion Criteria

  • History of diabetes, alcoholism, and/or other cause for neuropathy.

Lidoderm (GCO #98-855 NE IRB Approved through 9/30/00): Lidoderm is a local topical anesthetic, a gel you can apply to the area of pain, much like the novocaine you receive at your dentist.

You will be given the drug free of charge. You will not be reimbursed for travel expenses. You will be billed for the health services provided at Mount Sinai.

Inclusion Criteria

  • Must be diagnosed with HIV-associated distal sensory polyneuropathy (DSP)

Exclusion Criteria

  • Ulcers, lesions, or infections at site of pain

Lidoderm is an anesthetic, much like the novacaine you receive at your dentist.

Trials for HIV-Associated Myelopathy

Immunoglobin (GCO #96-672 NE IRB Approved through 10/31/00): Myelopathy is a disease which causes degeneration of the spinal cord. We are currently enrolling patients to study the effects of intravenous Immunoglobulin (IVIg) on HIV-associated myelopathy. Below are some symptoms of this disease:

  • Weakness of the arms or (especially) the legs
  • Partial paralysis, spasticity (muscle tightness) or an inability to control the legs
  • Unsteady, stiff, uncoordinated gait
  • Urinary frequency
  • For men: inability or difficulty achieving erection

It is believed that immune (defense system) system dysfunction may play an important role in this disease. Immunoglobulin is a naturally occurring substance found in the blood. It is part of the immune system's protection against harmful substances originating both inside and outside the body.

This study will provide two sets of IVIg infusions over 56 days.

Patients and/or their insurance companies will be responsible for the cost of the IVIg and nursing for the infusions. However, patients will be reimbursed for travel to and from Mount Sinai Hospital.

If you have been diagnosed with HIV-associated myelopathy or possess some of the above symptoms, you might consider participating in this clinical trial.

Exclusion Criteria

  • Active, uncontrolled seizures for 3 months before study entry
  • Major psychiatric disorder
  • Hypersensitivity to IVIg or IgA deficiency

Trials for HIV-Associated Myopathy

Intravenous Immunoglobin (GCO #96-671 NE IRB Approved through 10/31/00): Myopathy is a disease which causes deterioration of the muscles. We are currently enrolling patients for a clinical trial to study the effects of intravenous immunoglobulin (IVIg) on HIV myopathy. Classic symptoms of myopathy are:

  • Weakness of the limbs - especially the legs
  • Difficulty walking up stairs
  • Difficulty raising arms above head
  • Difficulty rising from a chair
  • Aching or cramping in legs

It is thought that immune (defense system) system dysfunction may play an important role in HIV-associated myopathy. Immunoglobulin is a naturally occurring substance found in the blood. It is part of the immune system's protection against harmful substances originating both inside and outside the body. This study will provide two sets of infusions of IVIg over 56 days and may improve the disability caused by the disease.

Patients and/or their insurance will be responsible for the cost of the IVIg and nursing for the infusions. However, patients will be reimbursed for travel to and from The Mount Sinai Hospital.

If you have been diagnosed with HIV-associated myopathy or have some of the above symptoms, you might consider participating in the clinical trial.

Exclusion Criteria

  • Major psychiatric disorder
  • Hypersensitivity to IVIg or IgA deficiency

Upcoming Clinical Trials

  • New agents are being considered for clinical trials for people who suffer from HIV peripheral neuropathy.
  • A hypnotherapy study is in development for people with documented HIV peripheral neuropathy.
  • A study investigating the Central Nervous System (CNS) side-effects of Sustiva (Efavarin) is in development.
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