Chronic Hepatitis CPhase 4PILOT-NRNCT00530972
Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies
A Phase 4 study testing Peginterferon alfa-2a plus ribavirin adjusted to body weight in people with Chronic Hepatitis C and HIV Infections, run by Hospital Carlos III, Madrid at 1 site in Spain.
Trial summary
To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who have relapsed or not responded to a previous suboptimal therapy based in Interferon. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C, HIV Infections
- What is being tested?
- Peginterferon alfa-2a plus ribavirin adjusted to body weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2006to 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 between 18 and 65 years of age
- Anti-HCV positive
- Detectable plasma HCV-RNA
- Relapsers after treatment with interferon o peginterferon +/- ribavirin
- HIV positive
- CD4 >/= 200 cell
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- Patients on clinically stable liver disease with:
- Hgb >/= 12 g/dL in women or 13 g/dL in men
- Leucocytes >/= 3000 mm3
- Neutrophil count (ANC) >/= 1500 cells/mm3
- Platelet count >/= 100.000 cells/mm3
- Normal prothrombin, bilirubin, albumin, creatinine and uric acid
- HBsAg negative
- With antecedents of diabetes or hypertension is necessary an previous ocular exploration
Who cannot join
- Women with ongoing pregnancy or breast feeding
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg
- Hemochromatosis
- Deficit of alfa-1 antitrypsin
- Wilson disease
- Alcoholic liver disease
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- Autoimmune hepatitis
- Hepatitis by toxin exposures
- Hepatitis by obesity
- Hemoglobinopathy (e.g. thalassemia)
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Hepatocarcinoma observed in the liver ecography.
- 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 significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
- Diabetes Mellitus
- 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
- Drug use within 6 months of 1st dose and excessive alcohol consumption.
- Concomitant treatment with ddI
- Male partners of women who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Patients With Chronic Hepatitis C Co-infected With HIV Relapsers or Non Responders, Previous Exposed to Sub-optimal Therapies: Open, Pilot Trial
To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who have relapsed or not responded to a previous suboptimal therapy based in Interferon.
Read the detailed description
An important number of co-infected patients were treated suboptimally in the past with others ineffective therapies interferon-based.
All co-infected patients should be an opportunity of retreatment with actually therapies.
- Conditions
- Chronic Hepatitis C, HIV Infections
- Being tested
- Peginterferon alfa-2a plus ribavirin adjusted to body weight
- Keywords
- co-infected HCV/HIV, relapsers
- Medical subject headings
- Hepatitis C, Chronic, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2a plus ribavirin adjusted to body weightDrug
PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg)
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon alfa-2a plus ribavirin | Experimental | Not described Receives: Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with RNA-HCV undetectable
Measured: 24 weeks after end of treatment
Secondary outcomes (3)
% of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy
Measured: At weeks 4, 12, 24 and 48 on treatment
Ribavirin levels
Measured: At weeks 4, 12, 24 and 48 on treatment
Impact of dose reduction peg-interferon and/or ribavirin
Measured: At weeks 4, 12, 24 and 48 on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionDec 2008
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Carlos III, Madrid
- Sponsor type
- University, hospital or other
- Investigators
- Vicente Soriano, Dr, Principal investigator, Hospital Carlos III. Madrid. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530972
- Sponsor's protocol ID
- 2005-001192-34
- Other IDs
- 2005
- Acronym
- PILOT-NR
- Status last verified
- Sep 2009
- First submitted
- 17 Sep 2007
- Last updated
- 7 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Chronic Hepatitis C Co-infected With HIV Relapsers or Non Responders, Previous Exposed to Sub-optimal Therapies: Open, Pilot Trial
- ClinicalTrials.gov ID
- NCT00530972
- Acronym / sponsor ID
- PILOT-NR / 2005-001192-34
- Conditions
- Chronic Hepatitis C, HIV Infections
- Keywords
- co-infected HCV/HIV, relapsers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Carlos III, MadridUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Sep 2007 (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.
To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who have relapsed or not responded to a previous suboptimal therapy based in Interferon.
Detailed description
An important number of co-infected patients were treated suboptimally in the past with others ineffective therapies interferon-based.
All co-infected patients should be an opportunity of retreatment with actually therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon alfa-2a plus ribavirin | Experimental | Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female patients between 18 and 65 years of age
- Anti-HCV positive
- Detectable plasma HCV-RNA
- Relapsers after treatment with interferon o peginterferon +/- ribavirin
- HIV positive
Key exclusion criteria (21 listed)
- Women with ongoing pregnancy or breast feeding
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg
- Hemochromatosis
- Deficit of alfa-1 antitrypsin
- Wilson disease
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 |
|---|---|---|
| Peginterferon alfa-2a plus ribavirin adjusted to body weightPegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg) | Drug | Peginterferon alfa-2a plus ribavirin |
Primary outcome
% of patients with RNA-HCV undetectable
Time frame: 24 weeks after end of treatment
3 secondary outcomes
% of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy
Time frame: At weeks 4, 12, 24 and 48 on treatment
Ribavirin levels
Time frame: At weeks 4, 12, 24 and 48 on treatment
Impact of dose reduction peg-interferon and/or ribavirin
Time frame: At weeks 4, 12, 24 and 48 on treatment
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 7 Sep 2009.
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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.
Vicente Soriano, Dr principal investigator
Hospital Carlos III. Madrid. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon alfa-2a plus ribavirin adjusted to body weight in people with Chronic Hepatitis C and HIV Infections, run by Hospital Carlos III, Madrid at 1 site 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 14 inclusion and 21 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 7 Sep 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 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?
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?
% of patients with RNA-HCV undetectable (time frame: 24 weeks after 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 7 Sep 2009.