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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Cognition Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Neurocognitive Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peptide T

Drug

Primary outcomes

Patients performance on neuropsychological tests

Time frame: 10 days plus 10 days plus 3 days

The additional 3 days was for only 4 patients with follow-up for 1 year

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health (NIMH)

Nih

Registry information

Important dates

Study start: 1988
Primary completion: 1990
First posted: Jan 18, 2000
Registry last updated: Mar 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed