The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System
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ClinicalTrials.gov Identifier: NCT01206933 |
Recruitment Status :
Completed
First Posted : September 22, 2010
Last Update Posted : February 10, 2016
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Condition or disease |
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Human Immunodeficiency Virus (HIV) Hepatitis C, Chronic |
Study Type : | Observational |
Actual Enrollment : | 20 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System. |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |
Group/Cohort |
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Detectable HIV RNA and HCV RNA
HIV and HCV co-infected with detectable HIV RNA and HCV RNA
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Undetectable HIV and Detectable HCV
HIV and HCV infected, HIV RNA Undetectable(treated) and Detectable HCV RNA.
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Undetectable HIV and HCV
HIV and HCV infected, Undetectable HIV RNA and HCV RNA
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Undetectable HCV
HCV(mono-infected,) HCV RNA undetectable
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Detectable HCV RNA
Monoinfected HCV, detectable RNA
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Detectable HIV RNA
Monoinfected HIV, Detectable RNA
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- Laboratory analysis of Tat Protein [ Time Frame: Single sample analysis ]The validation that HIV Tat protein is a potent inducer of HCV in dual infected patients will likely lead to anti-tat therapy to manage HCV patients for whom treatment options are rather limited.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Four groups of subjects will be included in this study, with 5 participants in each group:
- detectable HIV RNA (Ribonucleic Acid) and detectable HCV RNA
- undetectable HIV RNA (treated) and detectable HCV RNA
- undetectable HIV RNA (treated) and undetectable HCV RNA
- undetectable HCV RNA (mono-infected)
- detectable HCV RNA (mono-infected)
- detectable HIV RNA (mono-infected)
Inclusion Criteria:
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Meets one of the following criteria:
- detectable HIV RNA and detectable HCV RNA
- undetectable HIV RNA (treated) and detectable HCV RNA
- undetectable HIV RNA (treated) and undetectable HCV RNA
- undetectable HCV RNA (mono-infected)
- detectable HCV RNA (mono-infected)
- detectable HIV RNA (mono-infected)
Participants will be men and women, ages 18 and older, and who are patients being seen in the clinics of the Medical Faculty Associates, and meet the above criteria.
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206933
United States, District of Columbia | |
George Washington University Medical Faculty Associates | |
Washington, District of Columbia, United States, 20037 |
Principal Investigator: | David Parenti, MD | George Washington University |
Responsible Party: | George Washington University |
ClinicalTrials.gov Identifier: | NCT01206933 |
Other Study ID Numbers: |
GWUIRB #061012 |
First Posted: | September 22, 2010 Key Record Dates |
Last Update Posted: | February 10, 2016 |
Last Verified: | September 2010 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
HIV/HCV Coinfection Tat Protein HCV |
Hepatitis C Acquired Immunodeficiency Syndrome HIV Infections Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections |
RNA Virus Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Hepatitis, Chronic |