HIV/HCV Co-infectionPhase 4PEKARINCT00866021
Treatment of HIV/HCV Coinfection With Peg-IFN and Ribavirin in Patients Receiving ART Monotherapy With Lopinavir/r
A Phase 4 study testing Lopinavir/ritonavir and Lopinavir/ritonavir with two nucleoside analogs in people with HIV/HCV Co-infection and HIV Infections, run by Fundacion SEIMC-GESIDA at 10 sites in Spain.
Trial summary
The aim of this study is to assess the efficacy of lopinavir/r in monotherapy and peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/HCV Co-infection, HIV Infections
- What is being tested?
- Lopinavir/ritonavir and Lopinavir/ritonavir with two nucleoside analogs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 10 sitesSpain
- Study dates
- Feb 2008to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following criteria in the 30 days prior to study inclusion.
- Subject consent to participate in this study after being informed of all trial aspects that may influence his/her decision, given by signing and dating the informed consent form approved by the CREC of the corresponding center.
- Subject is at least 18 years old, is co-infected by HIV and HCV, and has been recommended treatment for HCV infection.
- Liver biopsy confirming the presence of chronic hepatitis performed within one year of patient entry into the study.
- Undetectable viral load (<50 cop/mL) during at least the 6 last months (confirmed). At least two viral load determinations lower than 50 cop/mL 6 months apart are required. The inclusion of patients showing one single "blip" during the pre-enrollment past 6 months is allowed. A "blip" is defined as a HIV viral load greater or equal to 50 cop/mL both preceded and followed of viral loads inferior to 50 cop/mL without changes in the antiretroviral treatment.
- CD4 at screening should be at least or greater to 350 cells/microl
Show all 19Show fewer
- Subject on continued, uninterrupted antiretroviral therapy for the past 6 months with
- LPV/r + 2 NRTIs/NtRTIs for at least 4 weeks;
- 1 NNRTI + 2 NRTIs
- 3 NRTIs Only changes in protease inhibitor due solely to toxicity, simplification, or optimization are acceptable
- Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
- Subject has a Karnofsky index >-70.
- Throughout the study, the patient does not require and agrees not to take any of the following drugs, that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, methylergonovine), pimozide, propafenone, and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication due to the possibility of a significant decrease in Kaletra concentrations during concomitant administration.
- Subject agrees not to take any medication, including over-the-counter medicines, alcohol, drugs, or herbal preparations without the knowledge and approval of the principal investigator.
- Laboratory tests have been made in the subject in the past 30 days.
- Hemoglobin >8.0 g/dL Absolute neutrophil count >750 cells/microL Platelet count >20.000/microL ALT or AST <5 x upper normal limit (UNL) Creatinine <1.5 x UNL
- Triglycerides <750 mg/dL.
- For women with childbearing potential, a negative result of a pregnancy test is available and they agree to use throughout the study at least two contraceptive methods (including a barrier one) of proven reliability in the investigator's opinion.
- In the case of men subjects, they are agreed to use during the hepatitis C treatment with ribavirin at least two contraceptive methods (including a barrier one).
Who cannot join
- Subjects will be excluded from study participation if they meet any of the following criteria:
- Subjects in whom a switch in protease inhibitor has ever been made due to suspected or documented virological failure.
- Subjects requiring treatment with drugs whose association with LPV/r is contraindicated based on Kaletra prescribing information..
- Active drug addiction or psychiatric disease that may prevent protocol compliance. Use of cannabis or being on methadone treatment are excepted, provided protocol compliance is not compromised in the investigator's opinion.
- Pregnancy or nursing, and in women of childbearing age, if they do not agree to use throughout the study a barrier contraceptive method of proven reliability in the investigator's opinion.
- In the opinion of the principal investigator, patient is unlikely to comply with the study protocol, or the patient was not eligible for any other reason.
- Subjects infected by the hepatitis B virus and who are being treated with tenofovir (TDF) or lamivudine (3TC).
- Prior treatment with interferon (pegylated or not) and/or ribavirin.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08910
Hospital General Sta. Mª del Rosell
Cartagena, Murcia, 30203
Hospital General de Castellón
Castellon, Castellón, 12004
Hospital Donostia
Donostia / San Sebastian, Guipuzcoa
Hospital Gregorio Marañón
Madrid, 28007
Hospital Ramón y Cajal
Madrid, 28034
Hospital la Paz
Madrid, 28046
Hospital La Princesa
Madrid
Hospital La Fe
Valencia, 46009
Hospital General Universitario de Valencia
Valencia, 46014
About this study
Official title: A Multicenter, Randomized, Open Label, Pilot Study to Assess the Possibility of Concomitant Treatment of HCV/HIV co Infection With Peg-interferon + Ribavirin, and Lopinavir/r as a Single Antiretroviral Agent.
The aim of this study is to assess the efficacy of lopinavir/r in monotherapy and peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV.
Read the detailed description
Viral hepatitis, mainly when caused by the hepatitis C virus (HCV), is highly significant in the setting of infection by the human immunodeficiency virus (HIV) because high activity antiretroviral therapy (HAART) has a very favorable impact upon morbidity and mortality of this disease. HAART has achieved disease control, significantly increasing survival and improving the quality of life of subjects with HIV infection.
Spain has one of the highest prevalences of HIV-HCV co-infection because both HCV and HIV infection are strongly associated to being or having been an intravenous drug user (IDU); thus, from 61% to 69% of these subjects infected by HIV in Spain are also infected by HCV.
From 1998, standard treatment for chronic C hepatitis consists of the combination of interferon alpha and ribavirin, based on an increased efficacy versus interferon monotherapy; however, development of pegylated interferon, with a more convenient bioavailability as compared to conventional interferon alpha, has allowed for developing even more effective combined therapies and the possibility of improving response prediction based on changes in viremia within the first few weeks of treatment. However, treatment of HCV infection usually involves severe side effects, which often lead to treatment discontinuation or to the need for adjusting drug dosage, in which case treatment efficacy may decrease.
HCV+ subjects who, because of HIV co-infection, should also receive HAART, may have an increased number or increased severity of adverse reactions due to interactions occurring with drug co-administration.
Lopinavir/ritonavir (LPV/r) is a potent HIV protease inhibitor and is characterized by a very high pharmacological and genetic barrier.
Different studies (subject cohorts, uncontrolled studies) during the past years have appeared in the literature showing the efficacy of LPV/r or controlling viral replication.
Most studies were conducted with the soft gel capsule formulation of LPV/r. In this study, the new formulation of LPV/r (Kaletra) as tablets approved by the FDA and EMEA (Spain authorization 30th Oct 2006) will be used. This new formulation will provide additional benefits to this strategy that has only been studied to date with soft gel capsules.
Based on the foregoing and on the additional cost savings involved in this strategy, we think that LPV/r, as single antiretroviral agent concomitantly administered with treatment for hepatitis C virus infection may provide significant benefits because it would prevent interactions between NRTIs and ribavirin, thus being potentially able to decrease the adverse events derived from mitochondrial toxicity and minimizing the possibility of anemia. In addition, replacement of NNRTIs by LPV/r may significantly decrease CNS involvement that may be enhanced by co-administration of efavirenz and peg-interferon, or minimize the risk of hepatotoxicity caused by nevirapine.
- Conditions
- HIV/HCV Co-infection, HIV Infections
- Being tested
- Lopinavir/ritonavir, Lopinavir/ritonavir with two nucleoside analogs
- Keywords
- HIV infection, HCV infection, treatment experienced
- Medical subject headings
- HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/ritonavirDrug
Also called Kaletra
NRTI sparing-regimen
Lopinavir/ritonavir with two nucleoside analogsDrug
LPV/r plus 2NRTIs + PEG-INF + RBV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lopinavir/ritonavir (LPV/r) as single antiretroviral administered concomitantly with peg-interferon and ribavirin Receives: Drug: Lopinavir/ritonavir |
| 2 | Active comparator | Lopinavir/ritonavir (LPV/r) with 2 NRTIs, administered concomitantly with peg-interferon and ribavirin Receives: Drug: Lopinavir/ritonavir with two nucleoside analogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess efficacy of concomitant treatment with lopinavir/r monotherapy and PEG-INF plus RBV for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV
Measured: 80 weeks
Secondary outcomes (4)
Tolerability and safety of concomitant treatment with LPV/r, PEG-INF and RBV
Measured: 80 weeks
CD4
Measured: 80 weeks
Efficacy
Measured: 80 weeks
Adherence
Measured: 80 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startFeb 2008
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/HCV Co-infectionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Enrique Ortega, Study chair, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866021
- Sponsor's protocol ID
- GESIDA-5506
- Other IDs
- 2007-003544-30
- Acronym
- PEKARI
- Status last verified
- Mar 2013
- First submitted
- 18 Mar 2009
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Pilot Study to Assess the Possibility of Concomitant Treatment of HCV/HIV co Infection With Peg-interferon + Ribavirin, and Lopinavir/r as a Single Antiretroviral Agent.
- ClinicalTrials.gov ID
- NCT00866021
- Acronym / sponsor ID
- PEKARI / GESIDA-5506
- Conditions
- HIV/HCV Co-infection, HIV Infections
- Keywords
- HIV infection, HCV infection, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Feb 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Mar 2009 (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.
The aim of this study is to assess the efficacy of lopinavir/r in monotherapy and peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV.
Detailed description
Viral hepatitis, mainly when caused by the hepatitis C virus (HCV), is highly significant in the setting of infection by the human immunodeficiency virus (HIV) because high activity antiretroviral therapy (HAART) has a very favorable impact upon morbidity and mortality of this disease. HAART has achieved disease control, significantly increasing survival and improving the quality of life of subjects with HIV infection.
Spain has one of the highest prevalences of HIV-HCV co-infection because both HCV and HIV infection are strongly associated to being or having been an intravenous drug user (IDU); thus, from 61% to 69% of these subjects infected by HIV in Spain are also infected by HCV.
From 1998, standard treatment for chronic C hepatitis consists of the combination of interferon alpha and ribavirin, based on an increased efficacy versus interferon monotherapy; however, development of pegylated interferon, with a more convenient bioavailability as compared to conventional interferon alpha, has allowed for developing even more effective combined therapies and the possibility of improving response prediction based on changes in viremia within the first few weeks of treatment. However, treatment of HCV infection usually involves severe side effects, which often lead to treatment discontinuation or to the need for adjusting drug dosage, in which case treatment efficacy may decrease.
HCV+ subjects who, because of HIV co-infection, should also receive HAART, may have an increased number or increased severity of adverse reactions due to interactions occurring with drug co-administration.
Lopinavir/ritonavir (LPV/r) is a potent HIV protease inhibitor and is characterized by a very high pharmacological and genetic barrier.
Different studies (subject cohorts, uncontrolled studies) during the past years have appeared in the literature showing the efficacy of LPV/r or controlling viral replication.
Most studies were conducted with the soft gel capsule formulation of LPV/r. In this study, the new formulation of LPV/r (Kaletra) as tablets approved by the FDA and EMEA (Spain authorization 30th Oct 2006) will be used. This new formulation will provide additional benefits to this strategy that has only been studied to date with soft gel capsules.
Based on the foregoing and on the additional cost savings involved in this strategy, we think that LPV/r, as single antiretroviral agent concomitantly administered with treatment for hepatitis C virus infection may provide significant benefits because it would prevent interactions between NRTIs and ribavirin, thus being potentially able to decrease the adverse events derived from mitochondrial toxicity and minimizing the possibility of anemia. In addition, replacement of NNRTIs by LPV/r may significantly decrease CNS involvement that may be enhanced by co-administration of efavirenz and peg-interferon, or minimize the risk of hepatotoxicity caused by nevirapine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lopinavir/ritonavirLopinavir/ritonavir (LPV/r) as single antiretroviral administered concomitantly with peg-interferon and ribavirin |
| 2 | Active comparator | Drug: Lopinavir/ritonavir with two nucleoside analogsLopinavir/ritonavir (LPV/r) with 2 NRTIs, administered concomitantly with peg-interferon and ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects must meet all the following criteria in the 30 days prior to study inclusion.
- Subject consent to participate in this study after being informed of all trial aspects that may influence his/her decision, given by signing and dating the informed consent form approved by the CREC of the corresponding center.
- Subject is at least 18 years old, is co-infected by HIV and HCV, and has been recommended treatment for HCV infection.
- Liver biopsy confirming the presence of chronic hepatitis performed within one year of patient entry into the study.
- Undetectable viral load (<50 cop/mL) during at least the 6 last months (confirmed). At least two viral load determinations lower than 50 cop/mL 6 months apart are required. The inclusion of patients showing one single "blip" during the pre-enrollment past 6 months is allowed. A "blip" is defined as a HIV viral load greater or equal to 50 cop/mL both preceded and followed of viral loads inferior to 50 cop/mL without changes in the antiretroviral treatment.
Key exclusion criteria (8 listed)
- Subjects will be excluded from study participation if they meet any of the following criteria:
- Subjects in whom a switch in protease inhibitor has ever been made due to suspected or documented virological failure.
- Subjects requiring treatment with drugs whose association with LPV/r is contraindicated based on Kaletra prescribing information..
- Active drug addiction or psychiatric disease that may prevent protocol compliance. Use of cannabis or being on methadone treatment are excepted, provided protocol compliance is not compromised in the investigator's opinion.
- Pregnancy or nursing, and in women of childbearing age, if they do not agree to use throughout the study a barrier contraceptive method of proven reliability in the investigator's opinion.
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 |
|---|---|---|
| Lopinavir/ritonavirAlso: KaletraNRTI sparing-regimen | Drug | 1 |
| Lopinavir/ritonavir with two nucleoside analogsLPV/r plus 2NRTIs + PEG-INF + RBV | Drug | 2 |
Primary outcome
Assess efficacy of concomitant treatment with lopinavir/r monotherapy and PEG-INF plus RBV for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV
Time frame: 80 weeks
4 secondary outcomes
Tolerability and safety of concomitant treatment with LPV/r, PEG-INF and RBV
Time frame: 80 weeks
CD4
Time frame: 80 weeks
Efficacy
Time frame: 80 weeks
Adherence
Time frame: 80 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 17 Mar 2025.
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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.
Enrique Ortega study chair
Hospital General Universitario de Valencia
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 Lopinavir/ritonavir and Lopinavir/ritonavir with two nucleoside analogs in people with HIV/HCV Co-infection and HIV Infections, run by Fundacion SEIMC-GESIDA 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 19 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 17 Mar 2025. 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?
Assess efficacy of concomitant treatment with lopinavir/r monotherapy and PEG-INF plus RBV for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV (time frame: 80 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 Mar 2025.