Human Immunodeficiency VirusDICONCT00909129
Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment
A study testing pegylated interferon-alpha (Pegasys) and ribavirin (COPEGUS) in people with Human Immunodeficiency Virus and Chronic Hepatitis C, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV and determine how these responses are affected by HCV treatment and correlates to response. Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment, and correlate this to treatment outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Chronic Hepatitis C
- What is being tested?
- pegylated interferon-alpha (Pegasys) and ribavirin (COPEGUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
Who may be able to join
- HIV-1 Hepatitis C coinfected adult patients
- Hepatitis C treatment naive
- Stable HIV-1 infection with or without cART
- > 300 CD4+ cell count
Who cannot join
- Decompensated liver disease
- Ongoing depression
- Ongoing drug abuse
- Other contraindications for interferon or ribavirin treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin
The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV and determine how these responses are affected by HCV treatment and correlates to response. Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment, and correlate this to treatment outcome.
- Conditions
- Human Immunodeficiency Virus, Chronic Hepatitis C
- Being tested
- pegylated interferon-alpha (Pegasys), ribavirin (COPEGUS)
- Keywords
- HIV-1, Chronic hepatitis C, Immune activation, HCV kinetics, IP-10
- 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.
pegylated interferon-alpha (Pegasys)Drug
Also called Pegasys (interferon)
Pegylated interferon-alpha 2a 180 micrograms s.c. weekly
ribavirin (COPEGUS)Drug
Also called COPEGUS (RIBAVIRIN)
ribavirin bid 800-1200 mg depending on HCV genotype and body weight
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 HCV coinfected patients | Experimental | HIV-1 HCV coinfected patients undergoing HCV therapy Receives: Drug: pegylated interferon-alpha (Pegasys); Drug: ribavirin (COPEGUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response
Measured: 24 weeks end of treatment (EOT)
Secondary outcomes (1)
T-cell mediated immune responses
Measured: baseline to 24 weeks EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Hoffmann-La Roche
- Investigators
- Annette Alaeus, MD;PhD, Principal investigator, Infectious Diseases Unit, Dept of Medicine Solna, Karolinska Institutet Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909129
- Sponsor's protocol ID
- 03-541
- Acronym
- DICO
- Status last verified
- May 2009
- First submitted
- 15 May 2009
- Last updated
- 27 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez VD, Falconer K, Michaelsson J, Moll M, Reichard O, Alaeus A, Sandberg JK. Expansion of CD56- NK cells in chronic HCV/HIV-1 co-infection: reversion by antiviral treatment with pegylated IFNalpha and ribavirin. Clin Immunol. 2008 Jul;128(1):46-56. doi: 10.1016/j.clim.2008.03.521. Epub 2008 May 20.
PubMed 18495540Falconer K, Askarieh G, Weis N, Hellstrand K, Alaeus A, Lagging M. IP-10 predicts the first phase decline of HCV RNA and overall viral response to therapy in patients co-infected with chronic hepatitis C virus infection and HIV. Scand J Infect Dis. 2010 Dec;42(11-12):896-901. doi: 10.3109/00365548.2010.498019. Epub 2010 Jul 7.
PubMed 20608766
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin
- ClinicalTrials.gov ID
- NCT00909129
- Acronym / sponsor ID
- DICO / 03-541
- Conditions
- Human Immunodeficiency Virus, Chronic Hepatitis C
- Keywords
- HIV-1, Chronic hepatitis C, Immune activation, HCV kinetics, IP-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Hoffmann-La Roche
- First posted
- 27 May 2009 (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.
The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV and determine how these responses are affected by HCV treatment and correlates to response. Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment, and correlate this to treatment outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 HCV coinfected patients | Experimental | Drug: pegylated interferon-alpha (Pegasys), Drug: ribavirin (COPEGUS)HIV-1 HCV coinfected patients undergoing HCV therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-1 Hepatitis C coinfected adult patients
- Hepatitis C treatment naive
- Stable HIV-1 infection with or without cART
- > 300 CD4+ cell count
Key exclusion criteria (4 listed)
- Decompensated liver disease
- Ongoing depression
- Ongoing drug abuse
- Other contraindications for interferon or ribavirin treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated interferon-alpha (Pegasys)Also: Pegasys (interferon)Pegylated interferon-alpha 2a 180 micrograms s.c. weekly | Drug | HIV-1 HCV coinfected patients |
| ribavirin (COPEGUS)Also: COPEGUS (RIBAVIRIN)ribavirin bid 800-1200 mg depending on HCV genotype and body weight | Drug | HIV-1 HCV coinfected patients |
Primary outcome
Sustained virological response
Time frame: 24 weeks end of treatment (EOT)
1 secondary outcome
T-cell mediated immune responses
Time frame: baseline to 24 weeks EOT
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 27 May 2009.
- Results publication: PubMed 18495540Gonzalez VD, Falconer K, Michaelsson J, Moll M, Reichard O, Alaeus A, Sandberg JK. Expansion of CD56- NK cells in chronic HCV/HIV-1 co-infection: reversion by antiviral treatment with pegylated IFNalpha and ribavirin. Clin Immunol. 2008 Jul;128(1):46-56. doi: 10.1016/j.clim.2008.03.521. Epub 2008 May 20.
- Derived from this study: PubMed 20608766Falconer K, Askarieh G, Weis N, Hellstrand K, Alaeus A, Lagging M. IP-10 predicts the first phase decline of HCV RNA and overall viral response to therapy in patients co-infected with chronic hepatitis C virus infection and HIV. Scand J Infect Dis. 2010 Dec;42(11-12):896-901. doi: 10.3109/00365548.2010.498019. Epub 2010 Jul 7.
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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.
Annette Alaeus, MD;PhD principal investigator
Infectious Diseases Unit, Dept of Medicine Solna, Karolinska Institutet Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pegylated interferon-alpha (Pegasys) and ribavirin (COPEGUS) in people with Human Immunodeficiency Virus and Chronic Hepatitis C, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 4 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 27 May 2009. 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 Sweden. 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?
Sustained virological response (time frame: 24 weeks end of treatment (EOT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00909129, which also lists 2 linked publications.
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 27 May 2009.