Completed

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

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 1988
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1988

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS). 
NCT00000393
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeMental DisordersCognition DisordersCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsNeurocognitive Disorders

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Los Angeles County - USC Med Ctr

Los Angeles, United StatesSee the location
CompletedOne Study Center