Human Immunodeficiency Virus (HIV)NCT01206933
The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System
An observational study of Human Immunodeficiency Virus (HIV) and Hepatitis C, Chronic, run by George Washington University at 1 site in United States.
Trial summary
Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Hepatitis C, Chronic
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Four groups of subjects will be included in this study, with 5 participants in each group: 1. detectable HIV RNA (Ribonucleic Acid) and detectable HCV RNA 2. undetectable HIV RNA (treated) and detectable HCV RNA 3. undetectable HIV RNA (treated) and undetectable HCV RNA 4. undetectable HCV RNA (mono-infected) 5. detectable HCV RNA (mono-infected) 6. detectable HIV RNA (mono-infected)
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System.
Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis.
Read the detailed description
Samples will be collected from 4 groups of patients with HIV/HCV infection, identified by the virologic control of either HIV, HCV, or both. Sera will be used in an in-vitro hepatocyte model of hepatitis C infection to better understand the pathogenesis of HIV/HCV co-infection, and to gain insight into intracellular mechanisms.
- Keywords
- HIV/HCV Coinfection, Tat Protein, HCV
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Detectable HIV RNA and HCV RNA | HIV and HCV co-infected with detectable HIV RNA and HCV RNA | |
| Undetectable HIV and Detectable HCV | HIV and HCV infected, HIV RNA Undetectable(treated) and Detectable HCV RNA. | |
| Undetectable HIV and HCV | HIV and HCV infected, Undetectable HIV RNA and HCV RNA | |
| Undetectable HCV | HCV(mono-infected,) HCV RNA undetectable | |
| Detectable HCV RNA | Monoinfected HCV, detectable RNA | |
| Detectable HIV RNA | Monoinfected HIV, Detectable RNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory analysis of Tat Protein
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.
Measured: Single sample analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Parenti, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206933
- Sponsor's protocol ID
- GWUIRB #061012
- Status last verified
- Sep 2010
- First submitted
- 17 Sep 2010
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System.
- ClinicalTrials.gov ID
- NCT01206933
- Acronym / sponsor ID
- GWUIRB #061012
- Keywords
- HIV/HCV Coinfection, Tat Protein, HCV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis.
Detailed description
Samples will be collected from 4 groups of patients with HIV/HCV infection, identified by the virologic control of either HIV, HCV, or both. Sera will be used in an in-vitro hepatocyte model of hepatitis C infection to better understand the pathogenesis of HIV/HCV co-infection, and to gain insight into intracellular mechanisms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Detectable HIV RNA and HCV RNA | – | –HIV and HCV co-infected with detectable HIV RNA and HCV RNA |
| Undetectable HIV and Detectable HCV | – | –HIV and HCV infected, HIV RNA Undetectable(treated) and Detectable HCV RNA. |
| Undetectable HIV and HCV | – | –HIV and HCV infected, Undetectable HIV RNA and HCV RNA |
| Undetectable HCV | – | –HCV(mono-infected,) HCV RNA undetectable |
| Detectable HCV RNA | – | –Monoinfected HCV, detectable RNA |
| Detectable HIV RNA | – | –Monoinfected HIV, Detectable RNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Four groups of subjects will be included in this study, with 5 participants in each group: 1. detectable HIV RNA (Ribonucleic Acid) and detectable HCV RNA 2. undetectable HIV RNA (treated) and detectable HCV RNA 3. undetectable HIV RNA (treated) and undetectable HCV RNA 4. undetectable HCV RNA (mono-infected) 5. detectable HCV RNA (mono-infected) 6. detectable HIV RNA (mono-infected)
Key inclusion criteria (8 listed)
- Meets one of the following criteria:
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Parenti, MD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV) and Hepatitis C, Chronic, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory analysis of Tat Protein (time frame: Single sample analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.