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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00000392
First received: January 17, 2000
Last updated: November 14, 2013
Last verified: October 2013

January 17, 2000
November 14, 2013
January 2000
August 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00000392 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
Not Provided

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • HIV Infections
  • Cognition Disorders
Drug: Peptide T
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000392
N01 MH00013, N01MH20004, N01MH20007
Not Provided
National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
Not Provided
Not Provided
National Institute of Mental Health (NIMH)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP