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

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000391
• Other study ID #: 89 MH-SF
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2000
• Last updated: March 2, 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 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 the bloodstream. To obtain information on the ability of intranasal peptide T to prevent, halt, and/or reverse the effects of AIDS on the central nervous system.

Studies have shown that AIDS is caused by a retrovirus. This virus works by inactivating or destroying human CD4 cells (which are part of the human immune system). This in turn leads to the observed immunologic defects and related illnesses, including HIV encephalopathy (disease of the brain). One method of preventing AIDS is to prevent HIV from entering the cell. HIV binds to the receptor CD4 site. Peptide T also binds to this site, and thus by competing for that site, can block the binding of the virus to its receptor. Preliminary animal and human studies indicate that peptide T is safe at the doses selected for this trial.

Thirty patients with AIDS or AIDS related complex (ARC) are entered into the study to receive an increasing schedule of three dosage levels of intranasal peptide T for 12 - 16 weeks followed by a 1-month off-drug follow-up period and a subsequent 1-month return to the drug. All patients receive an initial intravenous test dose of peptide T. The test dose is administered over 1 hour, followed by an observation period of 8 hours in the outpatient clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: January 1990
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Peptide T

Locations

Country	Name	City	State
United States	Fenway Clinic	Boston	Massachusetts

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	Radioimmunoassay for viral load	The subsequent return to the drug for 1 month is after a 1 month off-drug follow-up	12-16 weeks, 1 month	Yes