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TNC-CDAAR
Research
Domestic Research |
International Research |
Support |
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Study Profile:
Pilot study to evaluate a multidisciplinary treatment and support program to treat Hepatitis C virus (HCV) in patients coinfected with Human Immunodeficiency Virus (HIV)
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Revised: |
December 12, 2006 |
Study Site: |
The Miriam Hospital/Brown University School of Medicine |
Study Name: |
Pilot study to evaluate a multidisciplinary treatment and support program to treat Hepatitis C virus (HCV) in patients coinfected with Human Immunodeficiency Virus (HIV) |
Study Status: |
Completed |
Principal Investigator: |
Lynn E. Taylor, MD |
Years of Funding: |
2002 – 2003 |
Study Aims: |
The purpose of the project:
- To pilot and determine the feasibility of treating HCV in HIV/HCV coinfected patients with a history of psychiatric illness and/or addiction, with support of an intensive multidisciplinary team
- To pilot and determine the efficacy of a multidisciplinary treatment and support program to identify, monitor and treat side effects of pegylated interferon/ribavirin in HIV/HCV coinfected patients
- To evaluate the efficacy, safety, and tolerability of pegylated interferon/ribavirin in HIV/HCV coinfected patients who have a history of mood disorder and/or addiction
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Study or Clinic Location |
The Miriam Hospital |
# of Participants: |
Goal: |
10 – 15 patients |
Enrolled: |
17 patients |
Inclusion Criteria: |
HIV and HCV co-infection and meets eligibility for HCV treatment |
Exclusion Criteria: |
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Definition of Drug Use |
Use of the following in the past month (as well as frequency of use in the past month): Marijuana; smoked crack, cocaine, or rock; snorted cocaine; injected cocaine; injected cocaine and heroin together (speedballing); snorted heroin; injected heroin; street methadone; alcohol (beer, wine, hard liquor); other drugs smoked, sniffed, ingested, or injected |
Participant Characteristics: |
% Female: |
53% |
% HIV+ |
100% |
% DU (IDU or non-IDU) |
Approximately 94% |
Study Domains: |
Questionnaire:
- Program compliance and retention
- Side effects of treatment, tolerability
- Mood and affect, depression
- Quality of life
- Drug use/addiction status
Lab tests: (collected at baseline and intermittently through 72 weeks of follow-up)
- HCV RNA quantitative
- HCV geno
- CBC with differential
- PT/PTT/INR, UHCG, CD4, HIV PVL, ALT, AST, Alk Phos, Tbili, TSH, chem. 7, ferritin/TIBC/Fe, cholesterol/trig/LDL/HDL
- For cirrhotics: AFP/ultrasound
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Data collection instruments: |
In addition to above, available resources include the following:
- General clinic database: demographics, attendance, Liver biopsy results
- Clinic charts: psychiatric history, addiction history, genotype, ALT, CD4, PVL, HCV RNA, HBV sAg+, Extended LFTs
- Lab reports: IFN dose, Riba dose, growth factor (epo, neupogen, neumega) dose, HCV RNA quantitative, LFTs, TSH, Iron studies, CBC with differential, PT/PTT/INR, Chem 7, lipids, AFP (if cirrhotic)
- Immunology hepatitis database
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