Chronic Hepatitis CPhase 4NCT00611819
Two Different Treatments 24 vs 48 Weeks Chronic Hepatitis C Genotypes 2 and/or 3 in co-Infected HIV-HCV
A Phase 4 study testing Peg interferon + Ribavirin in people with Chronic Hepatitis C and Co-Infection HIV-HCV, run by University of Valencia at 18 sites in Spain.
Trial summary
The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment. Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C, Co-Infection HIV-HCV
- What is being tested?
- Peg interferon + Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 18 sitesSpain
- Study dates
- Nov 2005to Dec 2008
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients of 18-65 years of age
- Serologic evidence of chronic hepatitis C infection by detectable plasma HCV-RNA
- Serologic evidence of HIV-1 infection by ELISA and Western-blot
- Stable status of HIV-1 infection in the opinion of the investigator
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
- Willingness to give written informed consent and willingness to participate to and comply with the study
Who cannot join
- Women with ongoing pregnancy or breast feeding
- IFN or ribavirin therapy at any previous time
- Any investigational drug <6 weeks prior to the first dose of study drug
- History or other evidence of a medical condition associated with chronic liver disease other than HCV
- Hepatocarcinoma observed
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Show all 23Show fewer
- Active HIV-related opportunistic infection and/or malignancy requiring acute systemic therapy
- Absolute neutrophil count <1500 cells/mm3
- Hgb <12 g/dL in women or 13 g/dL in men or any patient for whom anemia would be medically problematic
- Hemoglobinopathy (e.g. thalassemia) or any other cause of or tendency for hemolysis
- Platelet count <90000 cells/mm3
- Serum creatinine level >1.5 times the upper limit of normal at screening
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of a severe seizure disorder or current anticonvulsant use
- History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
- History or other evidence of chronic pulmonary disease associated with functional limitation
- History of significant cardiac disease that could be worsened by acute anemia
- History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded
- Evidence of severe retinopathy
- History of major organ transplantation with an existing functional graft
- History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
- Drug use within 6 months of 1st dose and excessive alcohol consumption
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Hospital General de Alicante
Alicante, Alicante, 03010
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08915
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital General de Castellón
Castellon, Castellón, 12004
Hospital de Elche
Elche, Alicante, 03202
Hospital de Gandia
Gandia, Valencia, 46700
Hospital Clínico San Cecilio
Granada, Granada, 18013
Hospital Infanta Elena
Huelva, Huelva, 21004
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11009
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital la Paz
Madrid, Madrid, 28046
Hospital Carlos Haya
Málaga, Málaga, 29010
Hospital General de Murcia
Murcia, Murcia, 3003
Hospital Virgen Macarena
Seville, Sevilla, 41008
Hospital la Fe
Valencia, Valencia, 46009
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
Hospital Xeral-Cíes
Vigo, Pontevedra, 36204
About this study
Official title: Open, Randomized and Multicenter Phase IV Study to Compare the Efficacy and Safety of Two Different Treatments Duration 24 Versus 48 Weeks in Chronic Hepatitis C Genotypes 2 and/or 3 co-Infected HIV-HCV Patients.
The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment.
Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment.
Read more
In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%.
In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks.
In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.
Read the detailed description
Patients will randomized to receive 180 µg/weekly of Pef interferon alpha-2a and 800 mg/daily of Ribavirin during 24 weeks or 48 weeks.
- Conditions
- Chronic Hepatitis C, Co-Infection HIV-HCV
- Being tested
- Peg interferon + Ribavirin
- Keywords
- hepatitis, co-infection
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg interferon + RibavirinDrug
Also called Pegasys
Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
Peg interferon + RibavirinDrug
Also called Pegasys
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 24 weeks Receives: Drug: Peg interferon + Ribavirin |
| 2 | Active comparator | Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks Receives: Drug: Peg interferon + Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with RNA-HCV undetectable 24 weeks
Measured: 24 weeks after the end of treatment
Secondary outcomes (1)
% of patients at the end of treatment
Measured: 48 weeks of treatmemt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startNov 2005
- Primary completionApr 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Enrique Ortega, Dr, Study director, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611819
- Sponsor's protocol ID
- KHRONOS
- Other IDs
- 2005-000203-34, 2005
- Status last verified
- Jan 2008
- First submitted
- 25 Jan 2008
- Last updated
- 11 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized and Multicenter Phase IV Study to Compare the Efficacy and Safety of Two Different Treatments Duration 24 Versus 48 Weeks in Chronic Hepatitis C Genotypes 2 and/or 3 co-Infected HIV-HCV Patients.
- ClinicalTrials.gov ID
- NCT00611819
- Acronym / sponsor ID
- KHRONOS
- Conditions
- Chronic Hepatitis C, Co-Infection HIV-HCV
- Keywords
- hepatitis, co-infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Nov 2005
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 11 Feb 2008 (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 rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment.
Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment.
In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%.
In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks.
In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.
Detailed description
Patients will randomized to receive 180 µg/weekly of Pef interferon alpha-2a and 800 mg/daily of Ribavirin during 24 weeks or 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Peg interferon + RibavirinPeg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 24 weeks |
| 2 | Active comparator | Drug: Peg interferon + RibavirinPeg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients of 18-65 years of age
- Serologic evidence of chronic hepatitis C infection by detectable plasma HCV-RNA
- Serologic evidence of HIV-1 infection by ELISA and Western-blot
- Stable status of HIV-1 infection in the opinion of the investigator
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
Key exclusion criteria (23 listed)
- Women with ongoing pregnancy or breast feeding
- IFN or ribavirin therapy at any previous time
- Any investigational drug <6 weeks prior to the first dose of study drug
- History or other evidence of a medical condition associated with chronic liver disease other than HCV
- Hepatocarcinoma observed
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 |
|---|---|---|
| Peg interferon + RibavirinAlso: PegasysPeg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks | Drug | 1 |
| Peg interferon + RibavirinAlso: PegasysPeg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks | Drug | 2 |
Primary outcome
% of patients with RNA-HCV undetectable 24 weeks
Time frame: 24 weeks after the end of treatment
1 secondary outcome
% of patients at the end of treatment
Time frame: 48 weeks of treatmemt
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
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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.
Enrique Ortega, Dr study director
Hospital General Universitario de Valencia
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peg interferon + Ribavirin in people with Chronic Hepatitis C and Co-Infection HIV-HCV, run by University of Valencia at 18 sites in Spain.
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 6 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
% of patients with RNA-HCV undetectable 24 weeks (time frame: 24 weeks after the end of treatment). 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 11 Feb 2008.