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A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000393
First Posted: January 18, 2000
Last Update Posted: March 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
  Purpose

To study the safety, toxicology, and activity of Peptide T (D-Ala-1-peptide-T-amide) in humans and to find out more about the ability of peptide T to prevent, halt, and/or reverse AIDS-associated immunologic disturbances.

Recent information suggests that the central nervous system (CNS) is often impaired in HIV-infected individuals. The dysfunction of the CNS may be either a direct or an indirect result of HIV infection. One method to prevent HIV infection is to block entry of the virus into the cells of the body. Peptide T shows laboratory evidence of blocking the entrance of HIV into cells that are susceptible to HIV infection. Studies that have been done indicate that peptide T is nontoxic in the doses that are used in this study.

AIDS patients with minimal (group 1) or moderate (group 2) cognitive dysfunction (mental impairment) receive an increasing schedule of three dosage levels of peptide T. All patients receive an intravenous (IV) dose of peptide T for 10 days followed by the intermediate dose and then the highest dose, each intravenously for 10 days. Following successful completion of 3 IV doses, four patients participate in an intranasal pharmacokinetic (blood level study) dosage trial of 3 doses (different from IV) of peptide T once for each of 3 successive days. Follow-up continues for up to 1 year.


Condition Intervention Phase
HIV Infections Cognition Disorders Drug: Peptide T Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Patients performance on neuropsychological tests [ Time Frame: 10 days plus 10 days plus 3 days ]
    The additional 3 days was for only 4 patients with follow-up for 1 year


Enrollment: 6
Study Start Date: January 1988
Primary Completion Date: January 1990 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of either opportunistic infection and/or Kaposi's sarcoma, and/or serologic evidence of past infection with HIV. Ability to give informed consent.
  • Allowed but discouraged: Antiretroviral medication. Immunomodulating medication. Psychoactive medication.
  • Not breast-feeding
  • Abstinence or agree to use barrier methods of birth control / contraception during the study
  • Not pregnant
  • Negative pregnancy test
  • CD4 >= 200 cells/mm3 (200 - 300 - 400 - 500 - 600 - 700 - 800 plus).
  • Creatinine <= 1.6 mg/dl
  • Hemoglobin >= 12 g/dl
  • Platelet Count >= 100000 /mm3

Exclusion Criteria:

  • Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known.
  • Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known.
  • Excluded within 4 weeks of study entry:

Antiretroviral agents. Anticancer treatments. Psychoactive agents.

Excluded within 4 months of study entry:

Suramin.

  • Avoid: Antiretroviral medication. Immunomodulating medication. Psychoactive medication.
  • Excluded within 4 weeks of study entry:

Radiation.

  • Breast-feeding
  • Positive pregnancy test
  • Pregnant
  • No abstinence or no agreement to use barrier methods of birth control / contraception during the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000393


Locations
United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Study Chair: Bridge TP National Institute of Mental Health (NIMH)
  More Information

Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000393     History of Changes
Other Study ID Numbers: 89 MH-28
First Submitted: January 17, 2000
First Posted: January 18, 2000
Last Update Posted: March 2, 2015
Last Verified: April 2002

Keywords provided by National Institute of Mental Health (NIMH):
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Cognition Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Neurocognitive Disorders
Mental Disorders