Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.

Inclusion Criteria:

• Patients must have:

1. Cognitive dysfunction on neuropsychological testing.

2. HIV antibody positivity.

3. Expected survival of 6 months.

4. EITHER no use of an antiretroviral within the past 4 weeks OR use of approvedregimens of AZT, ddI, or ddC.

5. Medically stable EKG and urinalysis.

6. Given informed, written consent to participate.

• Allowed:

1. Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis,dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole,acyclovir.

2. Amitriptyline (up to 50 mg/day) or an equivalent dose of another antidepressantfor relief of peripheral neuropathy that is expected to remain unchangedthroughout the first 6 months of the study.

• Abstinence or agree to use barrier methods of birth control / contraception during thestudy

• Negative pregnancy test within 30 days of study entry

• Bilirubin <= 3

• CD4 (Must be <= 500 cells/mm3 if patient is without non-cognitive HIV-relatedsymptoms. CD4 count > 500 cells/mm3 allowed if patient has other (non-cognitive)HIV-related symptoms. ( 0 - 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 plus.)

• Creatinine <= 1.5 mg/dl

• Granulocytes >= 750

• Hemoglobin > 8 g/dl (No more than two transfusions per month permitted.)

• Other Lab Values Prothrombin time > 70 percent of control.

• Platelet Count >= 75000 /mm3

• SGOT(AST) < 5 x ULN (ULN = upper limit of normal).

Exclusion Criteria:

• Patients with the following are excluded:

1. History of mental retardation or learning disability.

2. Evidence of current DSM-III-R Axis I disorder within 3 months prior to studyentry or past history of psychotic disorder or bipolar mania.

3. History of neurologic disorder not secondary to HIV infection (e.g., head traumarequiring medical observation or hospitalization, seizure disorder).

• Patients with the following symptoms or conditions are excluded:

1. Kaposi's sarcoma or other malignancy likely to require chemotherapy during thefirst 6 months of the study.

2. Serious underlying medical problems that may complicate interpretation of thetreatment results, including unstable diabetes mellitus, severe arterioscleroticheart disease, uncontrolled hypertension, or hepatic or renal failure.

3. Non-HIV related condition that is likely to interfere with interpretation ofneuropsychologic test results.

4. Inability to participate in neuropsychologic testing or unable to comply withintranasal study medication administration.

• Excluded within 4 weeks prior to study entry:

1. Antiretrovirals except as allowed in the Patient Inclusion Criteria.

2. Psychoactive agents (e.g., benzodiazepines, antidepressants, antipsychotics,amphetamines) Excluded within 8 weeks prior to study entry: Long-acting psychoactive agents (e.g., Prozac).

• Active alcohol abuse in the past 3 months, or abuse judged by the investigators aslikely to interfere with the analyses of neuropsychologic function. Abuse of cocaine,marijuana, heroin or other opiates (including methadone), barbiturates, amphetaminesor other substances within the past 3 months, judged by the investigators as likely tointerfere with the analyses of neuropsychologic tests.

• Positive pregnancy test within 30 days of study entry

• No abstinence or no agreement to use barrier methods of birth control / contraceptionduring the study