Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00000393 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).
A Phase 1 study of HIV Infections and Cognition Disorders, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT00000393 is a Phase 1 study of HIV Infections and Cognition Disorders that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 6 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00000393, a Phase 1 study of HIV Infections and Cognition Disorders, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Peptide T
Study Locations (1)
California
- Los Angeles County - USC Med Ctr - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 1988-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000393
The ClinicalTrials.gov registry entry for NCT00000393 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Peptide T is the first listed.
NCT00000393 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00000393 about?
NCT00000393 is a clinical study titled "A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).". 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 im...
What is the current status of trial NCT00000393?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 1988-01.
What conditions does trial NCT00000393 study?
This clinical trial studies the following conditions: HIV Infections, Cognition Disorders.
What interventions are being tested in trial NCT00000393?
The interventions under investigation include: Peptide T (DRUG).
Who is sponsoring clinical trial NCT00000393?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000393 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
RECRUITING · Phase 1
-
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
RECRUITING · Phase 1
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
RECRUITING · Phase 1
-
First Time in Human Study of Long Acting VH4524184 Formulations
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.