Trial Outcomes & Findings for To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection (NCT NCT00959166)
NCT ID: NCT00959166
Last Updated: 2019-10-22
Results Overview
Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection by PK11195 PET ligand binding. The ligand PK11195 is selective for the peripheral benzodiazepine binding site and exhibits minimal binding in normal brain. In brain lesions, however, there is a massive increase in binding.
COMPLETED
NA
81 participants
30 days
2019-10-22
Participant Flow
Participant milestones
| Measure |
HIV/Acute HCV Coinfection
Subjects with HIV/acute HCV coinfection
|
HIV Mono
HIV-infected individuals without hepatitis C co-infection
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
57
|
|
Overall Study
COMPLETED
|
24
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection
Baseline characteristics by cohort
| Measure |
HIV/Acute HCV Coinfection
n=24 Participants
Subjects with HIV/acute HCV coinfection
|
HIV Mono
n=57 Participants
HIV-infected individuals without hepatitis C co-infection
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
n=99 Participants
|
47 years
n=107 Participants
|
44 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=99 Participants
|
57 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Time-elapsed since HIV diagnosis
|
6 years
n=99 Participants
|
11 years
n=107 Participants
|
8.5 years
n=206 Participants
|
|
Current CD4+ cells
|
590 cells/uL
n=99 Participants
|
505 cells/uL
n=107 Participants
|
547 cells/uL
n=206 Participants
|
|
Number of participants receiving antiretroviral therapy
|
17 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Plasma HIV viral load below 50c/ml
|
16 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 16 subjects in total had PET scans and were included in the PET outcome
Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection by PK11195 PET ligand binding. The ligand PK11195 is selective for the peripheral benzodiazepine binding site and exhibits minimal binding in normal brain. In brain lesions, however, there is a massive increase in binding.
Outcome measures
| Measure |
HIV/Acute HCV Coinfection
n=8 Participants
Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.
|
HIV Mono
n=8 Participants
HIV-infected individuals without hepatitis C co-infection
|
|---|---|---|
|
Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection
|
0.18 binding potential ratio
Standard Deviation 0.10
|
0.22 binding potential ratio
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 24/12 subjects in each study group had MR spectroscopy and could be included in this analysis
Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios. By quantifying the surrogate markers of N-acetylaspartate (NAA), creatine (Cr) offers insight into the neuronal integrity, cell membrane synthesis and turnover, macrophage infiltration, inflammation status, and levels of microglial activation and gliosis within the sampled CNS tissue.
Outcome measures
| Measure |
HIV/Acute HCV Coinfection
n=24 Participants
Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.
|
HIV Mono
n=12 Participants
HIV-infected individuals without hepatitis C co-infection
|
|---|---|---|
|
Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites
|
1.42 ratio
Standard Deviation 0.25
|
1.35 ratio
Standard Deviation 0.10
|
Adverse Events
HIV/Acute HCV Coinfection
HIV Mono
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place