Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00000391 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00000391: Completed Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT00000391 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000391, a Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
The subsequent return to the drug for 1 month is after a 1 month off-drug follow-up
Interventions
- DRUG Peptide T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1988-01 |
| Phase | Phase 1 |
What the finished NCT00000391 record still lists
NCT00000391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Peptide T is the first listed.
NCT00000391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000391 about?
NCT00000391 is a clinical study titled "A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.". 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/...
What is the current status of trial NCT00000391?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 1988-01.
What interventions are being tested in trial NCT00000391?
The interventions under investigation include: Peptide T (DRUG).
Who is sponsoring clinical trial NCT00000391?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000391's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia