Status:

COMPLETED

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

Lead Sponsor:

National Institute of Mental Health (NIMH)

Conditions:

HIV Infections

Cognition Disorders

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 immu...

Eligibility 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

Key Trial Info

Start Date :

January 1 1988

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

6 Patients enrolled

Trial Details

Trial ID

NCT00000393

Start Date

January 1 1988

Last Update

March 2 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Los Angeles County - USC Med Ctr

Los Angeles, California, United States, 90033

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