ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000392
  Purpose

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.


Condition Intervention Phase
HIV Infections
Cognition Disorders
Drug: Peptide T
Phase II

MedlinePlus related topics:   AIDS   

Drug Information available for:   Peptide T   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000392

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

Sponsors and Collaborators
  More Information


Study ID Numbers:   90 OD-0013
First Received:   January 17, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000392
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunologic Deficiency Syndromes
Cognition Disorders
Virus Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
HIV Seropositivity
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Dementia
Retroviridae Infections
Delirium

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers