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HCV CoinfectionPhase 2NCT01529073

Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection

A Phase 2 study testing Nitazoxanide in people with HCV Coinfection and HIV Infection, run by Juan Macías at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objectives: 1. Primary objective: To Evaluate the rate of sustained virological response (SVR) of pegylated interferon alfa-2b (Peg-IFN) plus ribavirin (RBV) plus nitazoxanide (NTZ) in patients coinfected by HIV and HCV genotype 4 (HCV-4), never treated before (naïve) and with a treatment failure to a standard therapy… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HCV Coinfection, HIV Infection
What is being tested?
Nitazoxanide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSpain
Study dates
Feb 2012to Feb 2015
Phase
Phase 2
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

  • HIV infection.
  • Infection with HCV genotype 4.
  • No prior treatment with any interferon or no response to a previous treatment with Peg-IFN plus RBV. The lack of response will include both nonresponders, and those who showed relapse.
  • Stable antiretroviral therapy 24 weeks before starting the study drugs, with undetectable plasma HIV RNA during that period of time.
  • Commitment to use two non-hormonal contraception during the study and up to 24 weeks after treatment.
  • Acceptance to give written informed consent to participate in the trial.

Who cannot join

  • Antiretroviral therapy including didanosine, stavudine, zidovudine and abacavir.
  • Decompensated cirrhosis.
  • Presence of other significant liver diseases, including chronic hepatitis or acute hepatitis B, acute hepatitis hepatitis A, hemochromatosis or deficiency of alpha-1 antitrypsin.
  • Pregnancy and lactation.
  • Men planning pregnancy with their partners during the study and up to 24 weeks after treatment.
  • Active or uncontrolled depression, other psychiatric illness, or disease during the previous year which may, in the investigator's opinion, prevent participation in the study.
Show all 19Show fewer
  • Previous suicide attempt.
  • Active thyroid disease or poorly controlled with treatment.
  • Previous autoimmune diseases such as inflammatory bowel disease, psoriasis serious, or rheumatoid arthritis, which may be exacerbated by interferon.
  • Chemotherapy or immunomodulatory 24 weeks before starting the study.
  • Serious illness, including cancer or unstable coronary disease, 24 weeks before starting the study.
  • Any chronic disease which, in the opinion of the investigator, may prevent complete the study.
  • Presence of acute or active opportunistic infections 48 weeks before starting the study.
  • Evidence of hepatocellular carcinoma or alpha-fetoprotein levels ≥ 50 ng / ml, unless an imaging technique shows no evidence of liver tumor, all obtained 24 weeks before starting the study.
  • Hemoglobinopathy or other conditions that may facilitate hemolysis.
  • Solid organ or bone marrow transplant.
  • Known hypersensitivity to any of the drugs under study.
  • Active consumption of drugs or alcohol in the opinion of the investigator would interfere with participation in the study. The use of methadone or other opiate replacement therapy is not considered an exclusion criterion.
  • Serious side effects from treatment with Peg-IFN plus RBV in patients with prior failure of such treatment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • H.U. Valme

    Seville, Seville, 41014

Other trials in Spain

About this study

Official title: Phase II Clinical Trial to Evaluate the Antiviral Activity of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in Individuals With Chronic Hepatitis Due to HCV Genotype 4 and Coinfected by HIV

Objectives: 1. Primary objective: To Evaluate the rate of sustained virological response (SVR) of pegylated interferon alfa-2b (Peg-IFN) plus ribavirin (RBV) plus nitazoxanide (NTZ) in patients coinfected by HIV and HCV genotype 4 (HCV-4), never treated before (naïve) and with a treatment failure to a standard therapy with Peg-IFN plus RBV (experienced), and to compare it with the rate of SVR of these patients with Peg-IFN plus RBV is a historical cohort. 2. Secondary objectives: In naive, as well as in experienced patients: a) To evaluate the virological activity at weeks 4 and 12 after starting the combination of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients. b) To analyze the safety of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients.

Design: Pilot clinical trial without control to evaluate efficacy and safety (phase II).

Read more

Patients: Individuals with HIV infection and with confirmed chronic HCV infection.

Treatment: NTZ 500 mg every 12 hours during 4 weeks, followed by NTZ 500 mg every 12 hours plus Peg-IFN plus weigh-adjusted RBV for 48 weeks. Total duration of therapy: 52 weeks.

Primary variable: The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing the programmed length of treatment.

Secondary variables: 1. The frequency of individuals with HCV RNA ≤10 IU/ml 12 weeks after finishing the programmed length of treatment. 2. The proportion of patients with HCV RNA ≤10 IU/ml at 4 and 12 weeks after adding PegIFN plus RBV to NTZ. 3. The frequency of severe adverse events.

Read the detailed description

Main Objective To evaluate the SVR rate of treatment with Peg-IFN alfa-2b plus RBV and NTZ in patients coinfected with HIV and HCV genotype 4, both never exposed to therapy against HCV or who failed a previous treatment with Peg-IFN plus RBV, and to compare with the SVR rate obtained in patients with Peg-IFN plus RBV in a historical cohort.

Secondary objectives: In naive, as well as in experienced patients:

  1. To evaluate the virological activity at weeks 4 and 12 after starting the combination of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients.
  2. To analyze the safety of Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients.

Design Single arm pilot clinical trial to evaluate safety and efficacy (phase II).

Disease or disorder under study Coinfection with HIV and HCV genotype 4.

Drugs under study Nitazoxanide 500 mg every 12 hours for 4 weeks followed by nitazoxanide 500 mg every 12 hours plus pegylated interferon alfa-2b 1.5 mcg/kg/week and weight-adjusted ribavirin for 48 weeks.

Study Population and total number of subjects Patients infected with HIV-1 with chronic HCV genotype 4 who meet the selection criteria.

Number of patients included in the study: 45.

Being tested
Nitazoxanide
Keywords
HIV, genotype 4 HCV, pegylated interferon, ribavirin, nitazoxanide
Medical subject headings
HIV Infections

What participants receive

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

  • NitazoxanideDrug

    Also called Alinia, Annita, Daxon, Dexidex

    Nitazoxanide 500 mg bid po for 4 weeks, followed by nitazoxanide 500 mg bid plus pegylated interferon alpha 2b 1.5 mg/kg/week sc plus weight-adjusted ribavirin po for 48 weeks.

Study groups in NCT01529073
Study groupRoleWhat they receive
NitazoxanideExperimentalNot described
Receives: Drug: Nitazoxanide

What is being measured

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

  1. Sustained virological response

    The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing the programmed length of treatment (52 weeks).

    Measured: 24 weeks after finishing the scheduled treatment

Secondary outcomes (1)

  1. Safety of Peg-interferon plus ribavirin plus nitazoxanide

    The proportion of patients with grade 3 or 4 adverse events according to the WHO classification.

    Measured: Every 4 weeks until 28 weeks of treatment, then every 8 weeks until the end of treatment (52 weeks)

Timeline

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

  1. First posted8 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2015 (estimated)
  4. Study completionFeb 2015 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01529073
Sponsor's protocol ID
NTZSPA001
Other IDs
2010-024336-42
Status last verified
Jan 2015
First submitted
5 Feb 2012
Last updated
14 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Macias J, Lopez-Cortes LF, Tellez F, Recio E, Ojeda-Burgos G, Rios MJ, Rivero-Juarez A, Delgado M, Rivas-Jeremias, Pineda JA. Low Efficacy of Pegylated Interferon plus Ribavirin plus Nitazoxanide for HCV Genotype 4 and HIV Coinfection. PLoS One. 2015 Dec 7;10(12):e0143492. doi: 10.1371/journal.pone.0143492. eCollection 2015.

    PubMed 26640956

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nitazoxanide in people with HCV Coinfection and HIV Infection, run by Juan Macías 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 6 inclusion and 19 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 14 Jan 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Sustained virological response (time frame: 24 weeks after finishing the scheduled treatment). 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 NCT01529073, 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 14 Jan 2015.

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