Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
Condition: HIV Infections; Cognition Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Intervention: Peptide T; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Summary:

      To evaluate the chemical efficacy and safety of intranasally administered peptide T on
      neurocognitive function in HIV seropositive individuals.

      Previous studies have shown that treatment with peptide T can result in cognitive improvement
      in HIV-infected patients.

      Patients are randomized to receive either peptide T or placebo for the first 6 months. All
      patients then receive open-label peptide T for approximately 6 additional months.
      Neuropsychologic tests are used to determine drug effects.
    

Eligibility criteria:

        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 approved
                  regimens 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 antidepressant
                  for relief of peripheral neuropathy that is expected to remain unchanged
                  throughout the first 6 months of the study.

          -  Abstinence or agree to use barrier methods of birth control / contraception during the
             study

          -  Negative pregnancy test within 30 days of study entry

          -  Bilirubin <= 3

          -  CD4 (Must be <= 500 cells/mm3 if patient is without non-cognitive HIV-related
             symptoms. 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 study
                  entry or past history of psychotic disorder or bipolar mania.

               3. History of neurologic disorder not secondary to HIV infection (e.g., head trauma
                  requiring 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 the
                  first 6 months of the study.

               2. Serious underlying medical problems that may complicate interpretation of the
                  treatment results, including unstable diabetes mellitus, severe arteriosclerotic
                  heart disease, uncontrolled hypertension, or hepatic or renal failure.

               3. Non-HIV related condition that is likely to interfere with interpretation of
                  neuropsychologic test results.

               4. Inability to participate in neuropsychologic testing or unable to comply with
                  intranasal 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 as
             likely to interfere with the analyses of neuropsychologic function. Abuse of cocaine,
             marijuana, heroin or other opiates (including methadone), barbiturates, amphetamines
             or other substances within the past 3 months, judged by the investigators as likely to
             interfere 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 / contraception
             during the study