Trial Outcomes & Findings for Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment. (NCT NCT00000392)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

215 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2017-02-28

Participant Flow

Of 457 persons screened for cognitive impairment, 205 men and 10 women were randomized (106 to peptide T and 109 to placebo).

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	106	109
Overall Study COMPLETED	66	77
Overall Study NOT COMPLETED	40	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peptide T n=106 Participants Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months Peptide T	Placebo n=109 Participants Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months Placebo	Total n=215 Participants Total of all reporting groups
Age, Customized 18-39 years	60 Participants n=5 Participants	62 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	104 Participants n=7 Participants	205 Participants n=5 Participants
Race/Ethnicity, Customized White	83 Participants n=5 Participants	94 Participants n=7 Participants	177 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Black	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	106 participants n=5 Participants	109 participants n=7 Participants	215 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

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

Outcome measures

Outcome measures
Measure	Peptide T n=66 Participants Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months Peptide T	Placebo n=77 Participants Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months Placebo
Change in Global Neurocognitive Performance z Score From Baseline	0.24 z score Standard Error 0.05	0.16 z score Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Outcome measures

Outcome measures
Measure	Peptide T n=66 Participants Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months Peptide T	Placebo n=77 Participants Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months Placebo
Change in Neurocognitive Performance Domain z Scores From Baseline Motor performance	0.19 z score Standard Error 0.06	0.18 z score Standard Error 0.06
Change in Neurocognitive Performance Domain z Scores From Baseline Verbal fluency	0.14 z score Standard Error 0.09	0.15 z score Standard Error 0.08
Change in Neurocognitive Performance Domain z Scores From Baseline Visuospatial ability	0.17 z score Standard Error 0.06	0.25 z score Standard Error 0.06
Change in Neurocognitive Performance Domain z Scores From Baseline Abstract thinking	0.34 z score Standard Error 0.07	0.23 z score Standard Error 0.04
Change in Neurocognitive Performance Domain z Scores From Baseline Speed of information processing	0.23 z score Standard Error 0.07	0.14 z score Standard Error 0.05
Change in Neurocognitive Performance Domain z Scores From Baseline Working memory	0.23 z score Standard Error 0.09	0.08 z score Standard Error 0.07
Change in Neurocognitive Performance Domain z Scores From Baseline Learning and retention	0.19 z score Standard Error 0.07	0.11 z score Standard Error 0.06

Adverse Events

Peptide T

Serious events: 8 serious events

Other events: 75 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peptide T n=106 participants at risk Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months Peptide T	Placebo n=109 participants at risk Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months Placebo
Immune system disorders Death	7.5% 8/106 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.	2.8% 3/109 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.

Other adverse events

Other adverse events
Measure	Peptide T n=106 participants at risk Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months Peptide T	Placebo n=109 participants at risk Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months Placebo
Psychiatric disorders Depression or Irritability	6.6% 7/106 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.	0.92% 1/109 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.
Skin and subcutaneous tissue disorders Rash	32.1% 34/106 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.	38.5% 42/109 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	11.3% 12/106 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.	4.6% 5/109 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.
Renal and urinary disorders Proteinuria	17.0% 18/106 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.	8.3% 9/109 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.
Blood and lymphatic system disorders Eosinophilia	3.8% 4/106 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.	0.00% 0/109 Only data for the events that were statistically significant between the two treatment groups could be retrieved because adverse event data are lost.

Additional Information

Benedetto Vitiello, MD - Supervisory Medical Officer

NIMH

Phone: 301-443-3357

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place