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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2002 by National Institute of Mental Health (NIMH). Recruitment status was Active, not recruiting

First Received on January 17, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00000391

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 I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Peptide T

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00000391 History of Changes
Other Study ID Numbers:	89 MH-SF
Study First Received:	January 17, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012