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

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ClinicalTrials.gov Identifier: NCT00000393
Recruitment Status : Completed
First Posted : January 18, 2000
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
HIV Infections Cognition Disorders Drug: Peptide T Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 1988
Actual Primary Completion Date : January 1990

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Study Chair: Bridge TP National Institute of Mental Health (NIMH)
More Information
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000393    
Other Study ID Numbers: 89 MH-28
First Posted: January 18, 2000    Key Record Dates
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:
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Acquired Immunodeficiency Syndrome
Cognition Disorders
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Neurocognitive Disorders
Mental Disorders