HCV CoinfectionPhase 4STERALNCT01900015
Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection
A Phase 4 study testing Raltegravir and Efavirenz in people with HCV Coinfection and HIV Infection, run by Juan Macías at 10 sites in Spain.
Trial summary
Primary Objective: To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HCV Coinfection, HIV Infection
- What is being tested?
- Raltegravir and Efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 10 sitesSpain
- Study dates
- 3 Feb 2014to 17 Jan 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each subject must be willing and able to provide written informed consent for the trial.
- Each subject must be ≥ 18 years of age.
- Each subject must be male or non-pregnant, non-breastfeeding female
- Each subject must have diagnosis of HIV infection.
- Each subject must have concomitant coinfection by HCV as shown by detectable plasma HCV RNA.
- Each subject must have stable treatment with EFV plus two nucleoside analogs for ≥24 weeks.
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- Each subject must have at least 2 documented plasma HIV RNA <50 copies/ml during the last 24 weeks, as observed in, at least, two clinical visits.
- Each subject must have HS involving more than 10% of hepatocytes, as determined by a CAP measurement ≥238 dB/m.
- Each sexually active female subject of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 3 months after stopping the medication.Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg,hysterectomy or tubal ligation).Postmenopausal women are not required to use contraception.Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period.
- Each sexually active male subject with a female partner(s) of child-bearing potential must also provide written informed consent to provide information regarding any pregnancy.
- Average daily alcohol intake lower than 50 g for men and 40 g for women.
Who cannot join
- The subject has an allergy/sensitivity to investigational product or its/their excipients.
- The female subject is nursing.
- The female subject is pregnant or intending to become pregnant.
- History of ARV failure or documented resistance.
- Baseline resistance to EFV or to any of the nucleoside analogues inhibitors in the regimen.
- The subject has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
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- The subject has active AIDS-defining event (CDC-C) within 24 weeks before screening.
- The subject is candidate for therapy against HCV infection during the 48 week trial period in the opinion of the investigator.
- The subject has a history of malignant neoplasia.
- Active illicit drug use or any other condition that may compromise the study drug adherence in the opinion of the investigators.
- The subject has used any investigational drugs within 30 days of Baseline.
- A subject who has participated in any other clinical trial within 30 days,inclusive, of signing the informed consent form of the current trial.
- The subject or a family member is among the personnel of the investigational or SPONSOR staff directly involved with this trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Universitario Reina Sofía
Córdoba
Hospital Infanta Elena
Huelva
Complejo Hospitalario de Jaen
Jaén
Hospital La Línea
La Línea de la Concepción, Cádiz
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Regional Universitario Carlos Haya
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
H.U. Valme
Seville, Seville, 41014
Hospital Universitario Virgen del Rocío
Seville
About this study
Official title: Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among HIV/HCV-Coinfected Patients Receiving Two Nucleoside Analogs Plus Efavirenz: The Steral Study
Primary Objective:
To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient.
Read more
Secondary Trial Objective:
- To compare the proportion of HIV/HCV-coinfected patients with one category decrease in the grade of HS between patients continuing with EFV plus two nucleoside analogs and those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.
- To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching.
Design:
Open-label, randomized clinical trial to evaluate safety (phase IV)
Condition:
HIV and HCV coinfection.
Intervention:
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Read the detailed description
Primary Objective:
To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient.
Secondary Trial Objective:
- To compare the proportion of HIV/HCV-coinfected patients with one category decrease in the grade of HS between patients continuing with EFV plus two nucleoside analogs and those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.
- To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching.
Design:
Open-label, randomized clinical trial to evaluate safety (phase IV)
Condition:
HIV and HCV coinfection.
Intervention:
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Study population and sample size HIV-infected patients with concomitant coinfection by HCV, as shown by detectable plasma HCV RNA, not candidates for therapy against HCV infection during the 48 week period of the Number of patients to recruit: 96, 48 patients per treatment group should be recruited.
- Conditions
- HCV Coinfection, HIV Infection
- Being tested
- Raltegravir, Efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Issentres
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
EfavirenzDrug
Also called Sustiva
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Active comparator | Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen. Receives: Drug: Raltegravir |
| Efavirenz | Active comparator | Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen. Receives: Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the impact of switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs versus keeping the same antiretroviral regimen on HS as measured by CAP among HIV/HCV-coinfected patients.
Measured: 48 weeks
Secondary outcomes (1)
To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching.
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 posted16 Jul 2013 (estimated)
- Study start3 Feb 2014
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCV CoinfectionStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Macías
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Juan Macías, Andaluz Health Service
- Investigators
- Juan Macías, MD, PhD, Principal investigator, Infectious Diseases and Microbiology Unit. Hospital Universitario de Valme. Servicio Andaluz de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900015
- Sponsor's protocol ID
- STERAL/50410
- Acronym
- STERAL
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2013
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Macias J, Mancebo M, Merino D, Tellez F, Montes-Ramirez ML, Pulido F, Rivero-Juarez A, Raffo M, Perez-Perez M, Merchante N, Cotarelo M, Pineda JA; Spanish AIDS Research Network-HEP09 Study Group. Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among Human Immunodeficiency Virus-Infected Patients With Nonalcoholic Fatty Liver Disease. Clin Infect Dis. 2017 Sep 15;65(6):1012-1019. doi: 10.1093/cid/cix467.
PubMed 28903510
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among HIV/HCV-Coinfected Patients Receiving Two Nucleoside Analogs Plus Efavirenz: The Steral Study
- ClinicalTrials.gov ID
- NCT01900015
- Acronym / sponsor ID
- STERAL / STERAL/50410
- Conditions
- HCV Coinfection, HIV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Juan MacíasOther government
- Study start
- 3 Feb 2014 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 16 Jul 2013 (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.
Primary Objective:
To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient.
Secondary Trial Objective:
- To compare the proportion of HIV/HCV-coinfected patients with one category decrease in the grade of HS between patients continuing with EFV plus two nucleoside analogs and those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.
- To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching.
Design:
Open-label, randomized clinical trial to evaluate safety (phase IV)
Condition:
HIV and HCV coinfection.
Intervention:
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Detailed description
Primary Objective:
To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient.
Secondary Trial Objective:
- To compare the proportion of HIV/HCV-coinfected patients with one category decrease in the grade of HS between patients continuing with EFV plus two nucleoside analogs and those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.
- To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching.
Design:
Open-label, randomized clinical trial to evaluate safety (phase IV)
Condition:
HIV and HCV coinfection.
Intervention:
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Study population and sample size HIV-infected patients with concomitant coinfection by HCV, as shown by detectable plasma HCV RNA, not candidates for therapy against HCV infection during the 48 week period of the Number of patients to recruit: 96, 48 patients per treatment group should be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Active comparator | Drug: RaltegravirPatients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen. |
| Efavirenz | Active comparator | Drug: EfavirenzPatients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Each subject must be willing and able to provide written informed consent for the trial.
- Each subject must be ≥ 18 years of age.
- Each subject must be male or non-pregnant, non-breastfeeding female
- Each subject must have diagnosis of HIV infection.
- Each subject must have concomitant coinfection by HCV as shown by detectable plasma HCV RNA.
Key exclusion criteria (13 listed)
- The subject has an allergy/sensitivity to investigational product or its/their excipients.
- The female subject is nursing.
- The female subject is pregnant or intending to become pregnant.
- History of ARV failure or documented resistance.
- Baseline resistance to EFV or to any of the nucleoside analogues inhibitors in the regimen.
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 |
|---|---|---|
| RaltegravirAlso: IssentresPatients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen. | Drug | Raltegravir |
| EfavirenzAlso: SustivaPatients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen. | Drug | Efavirenz |
Primary outcome
To compare the impact of switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs versus keeping the same antiretroviral regimen on HS as measured by CAP among HIV/HCV-coinfected patients.
Time frame: 48 weeks
1 secondary outcome
To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching.
Time frame: 48 weeks
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 25 Jul 2017.
- Derived from this study: PubMed 28903510Macias J, Mancebo M, Merino D, Tellez F, Montes-Ramirez ML, Pulido F, Rivero-Juarez A, Raffo M, Perez-Perez M, Merchante N, Cotarelo M, Pineda JA; Spanish AIDS Research Network-HEP09 Study Group. Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among Human Immunodeficiency Virus-Infected Patients With Nonalcoholic Fatty Liver Disease. Clin Infect Dis. 2017 Sep 15;65(6):1012-1019. doi: 10.1093/cid/cix467.
- Abstract presented at CROI 2017. Poster available to downloadLink provided by the sponsor.
- CROI webcast. THEMED DISCUSSION: OBESITY AND FATTY LIVER DISEASELink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Juan Macías, MD, PhD principal investigator
Infectious Diseases and Microbiology Unit. Hospital Universitario de Valme. Servicio Andaluz de Salud
10 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 Raltegravir and Efavirenz in people with HCV Coinfection and HIV Infection, run by Juan Macías at 10 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 11 inclusion and 13 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
To compare the impact of switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs versus keeping the same antiretroviral regimen on HS as measured by CAP among HIV/HCV-coinfected patients. (time frame: 48 weeks). 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 NCT01900015, 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 25 Jul 2017.