Status:

COMPLETED

A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.

Lead Sponsor:

National Institute of Mental Health (NIMH)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To study the safety and toxicity of intranasal peptide T (D-Ala-1-peptide-T-amide) in humans, and to find out how quickly and how much of a given dose enters the bloodstream and how quickly it leaves ...

Eligibility Criteria

Inclusion Criteria:

  • Patients must have:

HIV infection. Ability to give informed consent. Ability to participate in an outpatient study.

  • Allowed: Short course antimicrobials.
  • Not breast-feeding
  • Abstinence or agree to use barrier methods of birth control / contraception during the study
  • Not pregnant
  • Negative pregnancy test
  • CD4 100 to 500 cells/mm3 (100 - 200 - 300 - 400 - 500).
  • Creatinine > 1.6 mg/dl
  • Hemoglobin >= 12 g/dl
  • Platelet Count >= 100000 /mm3

Exclusion Criteria:

  • Excluded: Asymptomatic HIV seropositive or lymphadenopathy syndrome diagnoses only (CDC criteria).
  • Patients with the following conditions are excluded: Evidence of life-threatening opportunistic infection at time of entry into trial. Clinical evidence of active central nervous system disease secondary to immune dysregulation associated with HIV infection. Previous history of major psychiatric illness prior to 1977 or the time of initial exposure to HIV, if that is known. Evidence of clinically significant major psychiatric disturbance other than depression.
  • Excluded within 4 weeks of study entry: Suramin. Antiretroviral agents. Anticancer treatments. Psychoactive agents.
  • Excluded: Antivirals or immunomodulators.
  • Excluded within 4 weeks of study entry: Radiation.
  • Evidence of active substance abuse during 30 days prior to entry into trial. All behavior that can put patient at risk for reinfection with HIV: sexual contact with others known to have HIV infection, unsafe sexual practices, or sharing of needles or other intravenous equipment.
  • 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 :

30 Patients enrolled

Trial Details

Trial ID

NCT00000391

Start Date

January 1 1988

Last Update

March 3 2015

Active Locations (1)

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1

Fenway Clinic

Boston, Massachusetts, United States

A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients. | DecenTrialz