NCT00000392

Brief Summary

To evaluate the chemical efficacy and safety of intranasally administered peptide T on neurocognitive function in HIV seropositive individuals. Previous studies have shown that treatment with peptide T can result in cognitive improvement in HIV-infected patients. Patients are randomized to receive either peptide T or placebo for the first 6 months. All patients then receive open-label peptide T for approximately 6 additional months. Neuropsychologic tests are used to determine drug effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Jan 1990

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1990

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1996

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2000

Completed
15.6 years until next milestone

Results Posted

Study results publicly available

August 4, 2015

Completed
Last Updated

February 28, 2017

Status Verified

October 1, 2013

Enrollment Period

6.6 years

First QC Date

January 17, 2000

Results QC Date

July 17, 2015

Last Update Submit

February 27, 2017

Conditions

HIV InfectionsCognition Disorders

Keywords

Acquired Immunodeficiency SyndromeAIDS-Related Complex

Outcome Measures

Primary Outcomes (1)

  • Change in Global Neurocognitive Performance z Score From Baseline

    Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)

    Baseline and 6 months

Secondary Outcomes (1)

  • Change in Neurocognitive Performance Domain z Scores From Baseline

    Baseline and 6 months

Study Arms (2)

Peptide T

ACTIVE COMPARATOR

Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months

Drug: Peptide T

Placebo

PLACEBO COMPARATOR

Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months

Drug: Placebo

Interventions

Peptide TDRUG
Peptide T
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must have:
  • Cognitive dysfunction on neuropsychological testing.
  • HIV antibody positivity.
  • Expected survival of 6 months.
  • EITHER no use of an antiretroviral within the past 4 weeks OR use of approved regimens of AZT, ddI, or ddC.
  • Medically stable EKG and urinalysis.
  • Given informed, written consent to participate.
  • Allowed:
  • Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis, dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole, acyclovir.
  • Amitriptyline (up to 50 mg/day) or an equivalent dose of another antidepressant for relief of peripheral neuropathy that is expected to remain unchanged throughout the first 6 months of the study.
  • Abstinence or agree to use barrier methods of birth control / contraception during the study
  • Negative pregnancy test within 30 days of study entry
  • Bilirubin \<= 3
  • CD4 (Must be \<= 500 cells/mm3 if patient is without non-cognitive HIV-related symptoms. CD4 count \> 500 cells/mm3 allowed if patient has other (non-cognitive) HIV-related symptoms. ( 0 - 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 plus.)
  • Creatinine \<= 1.5 mg/dl
  • +5 more criteria

You may not qualify if:

  • Patients with the following are excluded:
  • History of mental retardation or learning disability.
  • Evidence of current DSM-III-R Axis I disorder within 3 months prior to study entry or past history of psychotic disorder or bipolar mania.
  • History of neurologic disorder not secondary to HIV infection (e.g., head trauma requiring medical observation or hospitalization, seizure disorder).
  • Patients with the following symptoms or conditions are excluded:
  • Kaposi's sarcoma or other malignancy likely to require chemotherapy during the first 6 months of the study.
  • Serious underlying medical problems that may complicate interpretation of the treatment results, including unstable diabetes mellitus, severe arteriosclerotic heart disease, uncontrolled hypertension, or hepatic or renal failure.
  • Non-HIV related condition that is likely to interfere with interpretation of neuropsychologic test results.
  • Inability to participate in neuropsychologic testing or unable to comply with intranasal study medication administration.
  • Excluded within 4 weeks prior to study entry:
  • Psychoactive agents (e.g., benzodiazepines, antidepressants, antipsychotics, amphetamines)
  • Excluded within 8 weeks prior to study entry:
  • Long-acting psychoactive agents (e.g., Prozac).
  • Active alcohol abuse in the past 3 months, or abuse judged by the investigators as likely to interfere with the analyses of neuropsychologic function. Abuse of cocaine, marijuana, heroin or other opiates (including methadone), barbiturates, amphetamines or other substances within the past 3 months, judged by the investigators as likely to interfere with the analyses of neuropsychologic tests.
  • Positive pregnancy test within 30 days of study entry
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

UCSD

San Diego, California, 92103, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Heseltine PN, Goodkin K, Atkinson JH, Vitiello B, Rochon J, Heaton RK, Eaton EM, Wilkie FL, Sobel E, Brown SJ, Feaster D, Schneider L, Goldschmidts WL, Stover ES. Randomized double-blind placebo-controlled trial of peptide T for HIV-associated cognitive impairment. Arch Neurol. 1998 Jan;55(1):41-51. doi: 10.1001/archneur.55.1.41.

    PMID: 9443710BACKGROUND

MeSH Terms

Conditions

HIV InfectionsCognition DisordersAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Peptide T

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeurocognitive DisordersMental DisordersSlow Virus Diseases

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Benedetto Vitiello, MD - Supervisory Medical Officer
Organization
NIMH
bvitiell@mail.nih.gov
301-443-3357

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2000

First Posted

January 18, 2000

Study Start

January 1, 1990

Primary Completion

August 1, 1996

Study Completion

August 1, 1996

Last Updated

February 28, 2017

Results First Posted

August 4, 2015

Record last verified: 2013-10

Locations

US(3)