A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.
Public ClinicalTrials.gov record NCT00000391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00000391
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 1987
- Primary completion
- Dec 31, 1989
- Completion
- Not listed
- Last update posted
- Mar 2, 2015
Started 1988
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fenway Clinic | Boston | Massachusetts | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 2, 2015 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00000391 live on ClinicalTrials.gov.