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

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000393
• Other study ID #: 89 MH-28
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2000
• Last updated: February 26, 2015
• Start date: January 1988

Study information

• Verified date: April 2002
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. primary completion date: January 1990
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cognition Disorders
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Peptide T

Locations

Country	Name	City	State
United States	Los Angeles County - USC Med Ctr	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients performance on neuropsychological tests	The additional 3 days was for only 4 patients with follow-up for 1 year	10 days plus 10 days plus 3 days	No