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

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Jan 17, 2000

Keywords

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Gender

ALL

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

Trial Officials