Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00000392
First received: January 17, 2000
Last updated: July 29, 2015
Last verified: October 2013
Results First Received: July 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: HIV Infections
Cognition Disorders
Interventions: Drug: Peptide T
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 457 persons screened for cognitive impairment, 205 men and 10 women were randomized (106 to peptide T and 109 to placebo).

Reporting Groups
  Description
Peptide T

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

Peptide T

Placebo

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

Placebo


Participant Flow:   Overall Study
    Peptide T     Placebo  
STARTED     106     109  
COMPLETED     66 [1]   77 [1]
NOT COMPLETED     40     32  
[1] provided complete NP outcome data constituted the sample for the primary efficacy analyses



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Peptide T

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

Peptide T

Placebo

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

Placebo

Total Total of all reporting groups

Baseline Measures
    Peptide T     Placebo     Total  
Number of Participants  
[units: participants]
  106     109     215  
Age, Customized [1]
[units: Participants]
     
18-39 years     60     62     122  
Gender  
[units: participants]
     
Female     5     5     10  
Male     101     104     205  
Race/Ethnicity, Customized [1]
[units: Participants]
     
White     83     94     177  
Hispanic     16     9     25  
Black     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     106     109     215  
[1] Information is not available for all participants.



  Outcome Measures
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1.  Primary:   Change in Global Neurocognitive Performance z Score From Baseline   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Change in Neurocognitive Performance Domain z Scores From Baseline   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Benedetto Vitiello, MD - Supervisory Medical Officer
Organization: NIMH
phone: 301-443-3357
e-mail: bvitiell@mail.nih.gov


Publications:

Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000392     History of Changes
Other Study ID Numbers: N01 MH00013, N01MH20004, N01MH20007
Study First Received: January 17, 2000
Results First Received: July 17, 2015
Last Updated: July 29, 2015
Health Authority: United States: Federal Government