N/A Completed N=81 Other

To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection

Source: ClinicalTrials.gov NCT00959166 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcomePrimary: Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection — 0.18; 0.22 binding potential ratio

Summary

This study plans to evaluate what happens to the brain in patients with HIV and early hepatitis C. The investigators will be comparing 3 groups of individuals: * Group 1: Individuals with HIV infection and acute (early) hepatitis C infection * Group 2: Individuals with HIV infection * Group 3: Healthy volunteers

Outcome Measures

Outcome	Result	p-value
PRIMARY Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection	0.18; 0.22	—
SECONDARY Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites	1.42; 1.35	—

Eligibility Criteria

Inclusion Criteria

HIV-1 antibody positive for at least 12 months
Acute HCV (Blood HCV PCR positive with negative PCR within past 8 months)
HCV genotype 1
Ability to give informed consent
Aged > 25 years
Male
Abbreviated Mental Test Score of at least 8/10

Exclusion Criteria

Evidence of established cirrhosis or encephalopathy
Commencing or any change to HIV medications within 12 weeks
Active opportunistic infection
Taking anti-depressants or any psychoactive medications within past 4 weeks
Use of benzodiazepines within past 4 weeks
Recent significant head injury
Established dementia
Alcohol dependence or recreational drug misuse
Untreated early syphilis
Hepatitis B infection (HBsAg positive)
Pregnancy
Unable to give informed consent
Any contraindication to MR scanning

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00959166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.