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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Cognition Disorders
• Intervention / Treatment: Drug: Placebo; Drug: Peptide T

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Los Angeles County - USC Med Ctr
    • San Diego, California, United States, 92103
      • UCSD
  • Florida
    • Miami, Florida, United States, 33136
      • Univ of Miami School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peptide T; Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months	Drug: Peptide T
Placebo Comparator: Placebo; Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Global Neurocognitive Performance z Score From Baseline	Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Neurocognitive Performance Domain z Scores From Baseline	Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)	Baseline and 6 months

Collaborators and Investigators

• Sponsor: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Heseltine PN, Goodkin K, Atkinson JH, Vitiello B, Rochon J, Heaton RK, Eaton EM, Wilkie FL, Sobel E, Brown SJ, Feaster D, Schneider L, Goldschmidts WL, Stover ES. Randomized double-blind placebo-controlled trial of peptide T for HIV-associated cognitive impairment. Arch Neurol. 1998 Jan;55(1):41-51. doi: 10.1001/archneur.55.1.41.

Study record dates

Study Major Dates

• Study Start: January 1, 1990
• Primary Completion (Actual): August 1, 1996
• Study Completion (Actual): August 1, 1996

Study Registration Dates

• First Submitted: January 17, 2000
• First Submitted That Met QC Criteria: January 17, 2000
• First Posted (Estimate): January 18, 2000

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: N01 MH00013