HCV Infection.HELICONNCT01277627
Influence of Nevirapine on HCV Viral Load
A study testing Nevirapine and efavirenz, protease inhibitors in people with HCV Infection. and HCV Viral Load., run by Valme University Hospital at 1 site in Spain.
Trial summary
Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in HIV/HCV-coinfected individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HCV Infection., HCV Viral Load.
- What is being tested?
- Nevirapine and efavirenz, protease inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Jul 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection.
- Older than 18 years.
- Chronic hepatitis C.
- Undetectable HIV viral load during one year before starting study.
- To have not received HCV therapy during one year before starting study.
- To have not started efavirenz or protease inhibitors o nucleoside analogs during 6 months before starting study.
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- Non contraindications for drugs included in this study.
- To change an antiretroviral regimen including efavirenz or protease inhibitors by nevirapine due to side effects, interactions or pregnancy (NVP group)
- To continue with a antiretroviral regimen including efavirenz or protease inhibitors (non-NVP group)
- Both groups will be matched according to these variables:
- Liver stiffness.
- HCV genotype.
- Hospital.
- Time from starting antiretroviral therapy.
- Previous third drug (EFV or PI) to introduction of NVP.
Who cannot join
- HCV therapy during follow-up
Trial locations and contacts
1 site in 1 country.
Spain1 site
Valme University Hospital
Seville, Seville, 41014
JOSE A MIRA-ESCARTI, M.D, +34-955015363, miraescarti@yahoo.es
JOSE A MIRA-ESCARTI, M.D
About this study
Official title: Influence of Nevirapine on HCV Viral Load Among HIV/HCV-coinfected Patients
Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in HIV/HCV-coinfected individuals.
- Conditions
- HCV Infection., HCV Viral Load.
- Being tested
- Nevirapine, efavirenz, protease inhibitors
- Keywords
- HCV, HIV, Nevirapine, HCV viral load, Efavirenz, Protease inhibitors
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
nevirapine: 400 mg a day.
efavirenz, protease inhibitorsDrug
efavirenz: 600 mg a day
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine | Active comparator | Not described Receives: Drug: Nevirapine; Drug: efavirenz, protease inhibitors |
| Non-nevirapine | Active comparator | Not described Receives: Drug: Nevirapine; Drug: efavirenz, protease inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HCV viral load
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV Infection.Studies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277627
- Sponsor's protocol ID
- JAP-NEV-2010-01
- Acronym
- HELICON
- Status last verified
- Dec 2010
- First submitted
- 14 Jan 2011
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nevirapine on HCV Viral Load Among HIV/HCV-coinfected Patients
- ClinicalTrials.gov ID
- NCT01277627
- Acronym / sponsor ID
- HELICON / JAP-NEV-2010-01
- Conditions
- HCV Infection., HCV Viral Load.
- Keywords
- HCV, HIV, Nevirapine, HCV viral load, Efavirenz, Protease inhibitors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Valme University HospitalUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (estimated)
- First posted
- 17 Jan 2011 (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.
Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in HIV/HCV-coinfected individuals.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nevirapine | Active comparator | Drug: Nevirapine, Drug: efavirenz, protease inhibitors |
| Non-nevirapine | Active comparator | Drug: Nevirapine, Drug: efavirenz, protease inhibitors |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- HIV infection.
- Older than 18 years.
- Chronic hepatitis C.
- Undetectable HIV viral load during one year before starting study.
- To have not received HCV therapy during one year before starting study.
Key exclusion criteria (1 listed)
- HCV therapy during follow-up
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 |
|---|---|---|
| Nevirapinenevirapine: 400 mg a day. | Drug | Nevirapine, Non-nevirapine |
| efavirenz, protease inhibitorsefavirenz: 600 mg a day | Drug | Nevirapine, Non-nevirapine |
Primary outcome
Changes in HCV viral load
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nevirapine and efavirenz, protease inhibitors in people with HCV Infection. and HCV Viral Load., run by Valme University Hospital 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 15 inclusion and 1 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 17 Jan 2011. 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.
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?
Contact JOSE MIRA-ESCARTI, M.D (+34-955015363, miraescarti@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HCV viral load (time frame: 48 weeks). 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 17 Jan 2011.