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HIV InfectionsPhase 3NCT00122616

Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C

A Phase 3 study testing Peginterferon alpha-2a (Pegasys®), Ribavirin and HIV antiretroviral therapy in people with HIV Infections and Hepatitis C, Chronic, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Hepatitis C, Chronic
What is being tested?
Peginterferon alpha-2a (Pegasys®), Ribavirin and HIV antiretroviral therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteFrance
Study dates
Nov 2003to Mar 2009
Phase
Phase 3
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 infection (Western Blot +)
  • C hepatitis (RNA viral hepatitis C [VHC] +)
  • Chronic active C hepatitis on liver histological score METAVIR (A over or equal to 1 and F over or equal to 2) on biopsy performed at least 18 months before the expected date of inclusion
  • Previous treatment for C hepatitis for at least 3 months including peg-interferon and ribavirin or peg-interferon alone if counterindication for ribavirin occurred
  • Failure to eradicate C hepatitis virus after well conducted treatment
  • The liver biopsy should have been realised at least 18 months before inclusion :
Show all 10Show fewer
  • Either before treatment for C hepatitis in patients treated at most 7 months Or at least 6 months after anti HCV treatment in patient treated for more than 7 months (wash out period)
  • Regular follow up in an outpatient clinic for HIV
  • Unchanged antiretroviral treatment the last 3 months before inclusion
  • Inform consent

Who cannot join

  • History of transplantation or clinical hepatic failure
  • Opportunistic infection in the past three months before inclusion
  • Any hepatic disease not related to HCV (B hepatitis, hemochromatosis, Wilson disease)
  • Diabetes mellitus
  • Immunocompromised treatment
  • Active intravenous drug addiction
  • Alcohol consumption of more than 50 g per day
  • Counterindication for the use of interferon

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de Maladies Infectieuses et de Réanimation Médicale

    Rennes, 35033

Other trials in France

About this study

Official title: Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and C Hepatitis Who Failed to Active Treatment for HCV. ANRSHC12 Fibrostop

The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. This scientific proof needs a comparative study to be done including two groups of patients randomly allocated: one with the treatment (peginterferon) and the other without any treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed; one before the study and a second 2 years after.

Read the detailed description

C hepatitis in HIV infected patient becomes a major issue although the survival of patients, has improved in the last decades regarding to the advent of HAART, the mortality related to liver disease has increased in this population. Sustained virological response for HCV can be obtained with peg-interferon and ribavirin treatment but more or less 50% of patients experienced failure to this treatment and liver fibrosis due to HCV infection progress and may lead to cirrhosis and hepato-carcinoma. To demonstrate the efficacy of peginterferon therapy to reduce the liver damage causes by HCV infection, a randomised controlled study is needed comparing one group of patient treated by peginterferon and one group without any treatment against HCV infection. In order to show 30% difference between the two groups in reducing one point of fibrosis score (METAVIR scale), 150 patients are needed. The duration of the study is 96 weeks

Being tested
Peginterferon alpha-2a (Pegasys®), Ribavirin, HIV antiretroviral therapy
Keywords
HIV infections, peginterferon alfa-2a, Treatment Failure, Hepatitis C, Chronic, Treatment Experienced
Medical subject headings
HIV Infections, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peginterferon alpha-2a (Pegasys®)Biological

    Peg-Interferon Alpha2a by subcutaneous injection, 180µg, once weekly

  • RibavirinDrug

    Ribavirin: tablet oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over 75 kg, once daily

  • HIV antiretroviral therapyDrug

    All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs

  • HIV antiretroviral therapyDrug

    All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs

Study groups in NCT00122616
Study groupRoleWhat they receive
Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapyActive comparatorDay0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
Receives: Biological: Peginterferon alpha-2a (Pegasys®); Drug: Ribavirin; Drug: HIV antiretroviral therapy
HIV antiretroviral therapyPlacebo comparatorDay0 to week 96: HIV antiretroviral therapy
Receives: Drug: HIV antiretroviral therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir).

    Measured: Week 96

Secondary outcomes (11)

  1. Distribution of the change of fibrosis Metavir score in each group

    Measured: Week 96

  2. Distribution of fibrosis score from Chevallier classification

    Measured: Week 96

  3. Plasmatic fibrosis markers dosages

    Measured: Week 96

  4. Viral load quantification for HIV and HCV

    Measured: Week 96

  5. Number and percentage of CD4/CD8 cell count throughout the study

    Measured: Day 0 to week 96

  6. Number and percentage of patient had more thand 200 copies/ml throughout the study

    Measured: Day 0 to week 96

  7. Occurrence of hepatic complication related to HCV

    Measured: Day0 to week 96

  8. Survival throughout the study

    Measured: Day 0 to week 96

  9. Quality of life questionnaire

    Measured: Day 0 to week 96

  10. Fibrotest (plasmatic fibrosis marker)

    Measured: Day 0, week 48 and week 96

  11. Histological improvement according to the total interferon dose received

    Measured: Day 0 to week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startNov 2003
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00122616
Sponsor's protocol ID
ANRSHC12 FIBROSTOP
Status last verified
Feb 2012
First submitted
19 Jul 2005
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Chapplain JM, Bellissant E, Guyader D, Molina JM, Poizot-Martin I, Perre P, Pialoux G, Turlin B, Mouchel C, Renault A, Michelet C; ANRS HC-12 Study Group. The effects of a maintenance therapy with peg-interferon alpha-2a on liver fibrosis in HIV/HCV co-infected patients: a randomized controlled trial. J Infect. 2013 Oct;67(4):313-21. doi: 10.1016/j.jinf.2013.05.007. Epub 2013 Jun 22.

    PubMed 23800784

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peginterferon alpha-2a (Pegasys®), Ribavirin and HIV antiretroviral therapy in people with HIV Infections and Hepatitis C, Chronic, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

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 10 inclusion and 8 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 22 Feb 2012. 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 France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir). (time frame: Week 96). 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 NCT00122616, which also lists 1 linked publication.

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 22 Feb 2012.

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