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

This study is ongoing, but not recruiting participants.

First Received: January 17, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00000393

Purpose

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.

Condition	Intervention	Phase
HIV Infections Cognition Disorders	Drug: Peptide T	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Peptide T

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000393

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Study Chair:

Bridge TP

More Information

No publications provided

Study ID Numbers:	89 MH-28
Study First Received:	January 17, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000393 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Cognition Disorders
Immunologic Deficiency Syndromes

Virus Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009