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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000391
First Posted: January 18, 2000
Last Update Posted: March 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
  Purpose

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.


Condition Intervention Phase
HIV Infections Drug: Peptide T Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Radioimmunoassay for viral load [ Time Frame: 12-16 weeks, 1 month ]
    The subsequent return to the drug for 1 month is after a 1 month off-drug follow-up


Enrollment: 30
Study Start Date: January 1988
Primary Completion Date: January 1990 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000391


Locations
United States, Massachusetts
Fenway Clinic
Boston, Massachusetts, United States
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Study Chair: Bridge TP National Institute of Mental Health (NIMH)
  More Information

Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000391     History of Changes
Other Study ID Numbers: 89 MH-SF
First Submitted: January 17, 2000
First Posted: January 18, 2000
Last Update Posted: March 3, 2015
Last Verified: April 2002

Keywords provided by National Institute of Mental Health (NIMH):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases