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A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).
Plain-language guide to NCT00000393: phase 1 non-randomized trial of Peptide T, 6 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00000393
- Phase
- phase 1
- Status
- completed
- Start
- 1988-01
- Completion (planned or actual)
- 1990-01
- Participants
- 6 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- HIV Infections; Cognition Disorders
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Peptide T.
The dysfunction of the CNS may be either a direct or an indirect result of HIV infection.
The registry classes the interventions as drug.
Who Took Part
The registry lists 6 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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. Abstinence or agree to use barrier methods of birth control / contraception during the study. Negative pregnancy test. CD4 \>= 200 cells/mm3 (200 - 300 - 400 - 500 - 600 - 700 - 800 plus).
The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: excluded within 4 weeks of study entry:; avoid: antiretroviral medication. immunomodulating medication. psychoactive medication; excluded within 4 weeks of study entry:.
How the Study Was Run
It was run as a non-randomized and open-label study.
Everyone knew when Peptide T was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 1988-01 with completion listed for 1990-01.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Patients performance on neuropsychological tests (time frame: 10 days plus 10 days plus 3 days).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Peptide T in 6 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Peptide T compound page, all human trials.
Our Notes on the Compound
Peptide T: A short synthetic peptide studied in the 1980s and 1990s for HIV-related conditions; its research form is D-Ala-Peptide-T-amide.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.