Search / Trial NCT00000391

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

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Jan 17, 2000

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex

Description

No description provided

Gender

All

Eligibility 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

Attachments

readout_NCT00000391_2024-05-23.pdf

4.5 MB

NCT00000391_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

12-16 weeks, 1 month

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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