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

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ClinicalTrials.gov Identifier: NCT00000392
Recruitment Status : Completed
First Posted : January 18, 2000
Results First Posted : August 4, 2015
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions HIV Infections
Cognition Disorders
Interventions Drug: Peptide T
Drug: Placebo
Enrollment 215
Recruitment Details  
Pre-assignment Details Of 457 persons screened for cognitive impairment, 205 men and 10 women were randomized (106 to peptide T and 109 to placebo).
Arm/Group Title Peptide T Placebo
Hide Arm/Group Description

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

Peptide T

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

Placebo

Period Title: Overall Study
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
Arm/Group Title Peptide T Placebo Total
Hide Arm/Group Description

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

Peptide T

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

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 106 109 215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
18-39 years Number Analyzed 106 participants 109 participants 215 participants
60 62 122
[1]
Measure Description: Information is not available for all participants.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 109 participants 215 participants
Female
5
   4.7%
5
   4.6%
10
   4.7%
Male
101
  95.3%
104
  95.4%
205
  95.3%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 109 participants 215 participants
White 83 94 177
Hispanic 16 9 25
Black 5 5 10
[1]
Measure Description: Information is not available for all participants.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 109 participants 215 participants
106 109 215
1.Primary Outcome
Title Change in Global Neurocognitive Performance z Score From Baseline
Hide Description Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide T Placebo
Hide Arm/Group Description:

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

Peptide T

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

Placebo

Overall Number of Participants Analyzed 66 77
Mean (Standard Error)
Unit of Measure: z score
0.24  (0.05) 0.16  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peptide T, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Neurocognitive Performance Domain z Scores From Baseline
Hide Description Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide T Placebo
Hide Arm/Group Description:

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

Peptide T

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

Placebo

Overall Number of Participants Analyzed 66 77
Mean (Standard Error)
Unit of Measure: z score
Verbal fluency 0.14  (0.09) 0.15  (0.08)
Visuospatial ability 0.17  (0.06) 0.25  (0.06)
Abstract thinking 0.34  (0.07) 0.23  (0.04)
Speed of information processing 0.23  (0.07) 0.14  (0.05)
Working memory 0.23  (0.09) 0.08  (0.07)
Learning and retention 0.19  (0.07) 0.11  (0.06)
Motor performance 0.19  (0.06) 0.18  (0.06)
Time Frame [Not Specified]
Adverse Event Reporting Description Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.
 
Arm/Group Title Peptide T Placebo
Hide Arm/Group Description

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

Peptide T

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

Placebo

All-Cause Mortality
Peptide T Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Peptide T Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/106 (7.55%)   3/109 (2.75%) 
Immune system disorders     
Death  8/106 (7.55%)  3/109 (2.75%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Peptide T Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   75/106 (70.75%)   57/109 (52.29%) 
Blood and lymphatic system disorders     
Eosinophilia  4/106 (3.77%)  0/109 (0.00%) 
Psychiatric disorders     
Depression or Irritability  7/106 (6.60%)  1/109 (0.92%) 
Renal and urinary disorders     
Proteinuria  18/106 (16.98%)  9/109 (8.26%) 
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion  12/106 (11.32%)  5/109 (4.59%) 
Skin and subcutaneous tissue disorders     
Rash  34/106 (32.08%)  42/109 (38.53%) 
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
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000392     History of Changes
Other Study ID Numbers: N01 MH00013
First Submitted: January 17, 2000
First Posted: January 18, 2000
Results First Submitted: July 17, 2015
Results First Posted: August 4, 2015
Last Update Posted: February 28, 2017