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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1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033