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A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).

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ClinicalTrials.gov Identifier: NCT00000393
Recruitment Status : Completed
First Posted : January 18, 2000
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)

Tracking Information
First Submitted Date  ICMJE January 17, 2000
First Posted Date  ICMJE January 18, 2000
Last Update Posted Date March 2, 2015
Study Start Date  ICMJE January 1988
Actual Primary Completion Date January 1990   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
Patients performance on neuropsychological tests [ Time Frame: 10 days plus 10 days plus 3 days ]
The additional 3 days was for only 4 patients with follow-up for 1 year
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).
Official Title  ICMJE Not Provided
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Cognition Disorders
Intervention  ICMJE Drug: Peptide T
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2015)
6
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 1990   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • Not breast-feeding
  • Abstinence or agree to use barrier methods of birth control / contraception during the study
  • Not pregnant
  • Negative pregnancy test
  • CD4 >= 200 cells/mm3 (200 - 300 - 400 - 500 - 600 - 700 - 800 plus).
  • Creatinine <= 1.6 mg/dl
  • Hemoglobin >= 12 g/dl
  • Platelet Count >= 100000 /mm3

Exclusion Criteria:

  • Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known.
  • Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known.
  • Excluded within 4 weeks of study entry:

Antiretroviral agents. Anticancer treatments. Psychoactive agents.

Excluded within 4 months of study entry:

Suramin.

  • Avoid: Antiretroviral medication. Immunomodulating medication. Psychoactive medication.
  • Excluded within 4 weeks of study entry:

Radiation.

  • Breast-feeding
  • Positive pregnancy test
  • Pregnant
  • No abstinence or no agreement to use barrier methods of birth control / contraception during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000393
Other Study ID Numbers  ICMJE 89 MH-28
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Mental Health (NIMH)
Study Sponsor  ICMJE National Institute of Mental Health (NIMH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bridge TP National Institute of Mental Health (NIMH)
PRS Account National Institute of Mental Health (NIMH)
Verification Date April 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP