HIV InfectionsPhase 3NCT00437476
Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-HCV Therapy
A Phase 3 study testing LPV/r, Nucleoside Reverse Transcriptase Inhibitors and PEG-IFNa 2a in people with HIV Infections and Hepatitis C, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in patients naive for HIV and HCV. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Hepatitis C
- What is being tested?
- LPV/r, Nucleoside Reverse Transcriptase Inhibitors and PEG-IFNa 2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2007to Dec 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is >18 years old
- Subject has given written informed consent
- Serologic evidence of HIV infection by HIV antibody and HIV-RNA detection
- Serologic evidence of HCV infection by HCV antibody and HCV-RNA detection
- Subject is naive for HIV and HCV therapy
- Subject has active chronic hepatitis or compensated cirrhosis (Child-Pugh class A)
Show all 9Show fewer
- Subject has a CD4+ count > 200 cell/mm3 and <500 cell/mm3.
- Subject has genotype available at baseline and no mutations (IAS)associated with resistance to antiretroviral drugs used.
- Subject and partner will use effective contraceptive methods for the duration of the study
Who cannot join
- Subject is HbsAg positive
- Subject has cirrhosis score Child-Pugh B/C, no previous hepatic decompensation
- Subject has HIV-related thrombocytopenia (Platelets count < 50.000 mmc)
- Subject has neutrophils count < 1500/mmc
- Subject has Hb value < 9 g/dL at screening and <11 g/dL at randomization
- Subject has creatinine value > 1.5 mg/dL
Show all 14Show fewer
- Subject is on a HAART regimen included ddI and/or AZT
- Subject is pregnant or wishes to become so
- Subject has any cause of liver disease other than chronic hepatitis C, status of liver decompensation or any other condition consistent with decompensated liver disease (bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy)
- Subject is alcohol abuser (> 30 gr/die)
- Prior treatment with PEG-IFN/ribavirin
- Illicit drugs abuse that in the opinion of the investigator could lead to poor compliance with the terms of the protocol (maintenance treatment with methadone allowed)
- Active heart disease (e.g. angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia)
- Subject has pre-existing severe depression, condition of severe psychiatric disorders such as suicidal ideation, suicide attempts, depression or acute psychosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital Dep. Infectious Diseases
Milan, 20127
Vega Rusconi, +39/02/26433646, vega.rusconi@hsr.it
Giulia Gallotta, MD, +39/02/26437938, giulia.gallotta@hsr.it
About this study
Official title: Pilot, Multicenter, Randomized Study on Lopinavir/Ritonavir-Monotherapy vs Lopinavir/Ritonavir Plus Selected Nucs, in HIV/HCV ARV-Naive Coinfected Patients With Chronic Hepatitis C or Compensated Cirrhosis, Starting Treatment With Ribavirin and Pegylated Interferon
The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in patients naive for HIV and HCV.
Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART.
Read the detailed description
This is a pilot, randomised, open label, controlled clinical trial. All eligible patients (CD4 count > 200 and no PI resistance)will receive 26 weeks induction HAART (LPV/r + selected NUCS). At the end of induction period (Phase I), all subjects with negative HIV-RNA from at least two months, Hb > 11 g/dL and CD4 count > 350 cells/mmc will be randomised (1:1), to receive LPV/r new tabs (200/50 mg, 2 cpr BID) monotherapy (arm A) or to continue the same HAART (arm B), associated to anti-HCV therapy for other 48 weeks (Phase II). The number of subjects to recruit will be 60 subjects to start the induction-phase with the aim to randomize, at least 25 subjects in each arm of the study. The total number of subjects to randomize will be 50. The Group A: will receive LPV/r + selected NRTIs for 26 weeks, followed by LPV/r monotherapy and anti HCV drugs for 48 weeks. Group B: will receive LPV/r+ selected NRTIs for 24 weeks, followed by the same HAART and anti-HCV drugs for 48 weeks. At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decision.All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs.
- Conditions
- HIV Infections, Hepatitis C
- Being tested
- LPV/r, Nucleoside Reverse Transcriptase Inhibitors, PEG-IFNa 2a, Ribavirin
- Keywords
- HIV/HCV, HIV and HCV coinfected patients, Treatment Naive
- 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.
LPV/rDrug
Lopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B)
Nucleoside Reverse Transcriptase InhibitorsDrug
NRTIs for 26 weeks (A) or 24 weeks (B)
PEG-IFNa 2aDrug
PEG-IFNa 2a 180 mcg/week (48 weeks)
RibavirinDrug
Ribavirin 1-1.2 g/day (48 weeks)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | LPV/r + selected NRTIs for 26 weeks, followed by LPV/r monotherapy and anti HCV drugs for 48 weeks. All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs. Receives: Drug: LPV/r; Drug: Nucleoside Reverse Transcriptase Inhibitors; Drug: PEG-IFNa 2a; Drug: Ribavirin |
| B | Active comparator | LPV/r+ selected NRTIs for 24 weeks, followed by the same HAART and anti-HCV drugs for 48 weeks. At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decision. All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs. Receives: Drug: LPV/r; Drug: Nucleoside Reverse Transcriptase Inhibitors; Drug: PEG-IFNa 2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if the combination of LPV/r monotherapy in association with
Measured: 18 months
anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional
Measured: 18 months
toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin
Measured: 18 months
in patients naïve for HIV and HCV
Measured: 18 months
Secondary outcomes (3)
To assess if LPV/r monotherapy during the HCV treatment
Measured: 18 and 24 months
is associated with anti HIV efficacy and a better patient satisfaction
Measured: 18 and 24 months
vs optimized HAART.
Measured: 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJul 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Hoffmann-La Roche
- Investigators
- Adriano Lazzarin, MD, Principal investigator, IRCCS San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437476
- Sponsor's protocol ID
- Kamon 1
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2007
- Last updated
- 6 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Multicenter, Randomized Study on Lopinavir/Ritonavir-Monotherapy vs Lopinavir/Ritonavir Plus Selected Nucs, in HIV/HCV ARV-Naive Coinfected Patients With Chronic Hepatitis C or Compensated Cirrhosis, Starting Treatment With Ribavirin and Pegylated Interferon
- ClinicalTrials.gov ID
- NCT00437476
- Acronym / sponsor ID
- Kamon 1
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- HIV/HCV, HIV and HCV coinfected patients, Treatment Naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Abbott, Hoffmann-La Roche
- Study start
- Feb 2007
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 21 Feb 2007 (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 purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in patients naive for HIV and HCV.
Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART.
Detailed description
This is a pilot, randomised, open label, controlled clinical trial. All eligible patients (CD4 count > 200 and no PI resistance)will receive 26 weeks induction HAART (LPV/r + selected NUCS). At the end of induction period (Phase I), all subjects with negative HIV-RNA from at least two months, Hb > 11 g/dL and CD4 count > 350 cells/mmc will be randomised (1:1), to receive LPV/r new tabs (200/50 mg, 2 cpr BID) monotherapy (arm A) or to continue the same HAART (arm B), associated to anti-HCV therapy for other 48 weeks (Phase II). The number of subjects to recruit will be 60 subjects to start the induction-phase with the aim to randomize, at least 25 subjects in each arm of the study. The total number of subjects to randomize will be 50. The Group A: will receive LPV/r + selected NRTIs for 26 weeks, followed by LPV/r monotherapy and anti HCV drugs for 48 weeks. Group B: will receive LPV/r+ selected NRTIs for 24 weeks, followed by the same HAART and anti-HCV drugs for 48 weeks. At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decision.All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: LPV/r, Drug: Nucleoside Reverse Transcriptase Inhibitors, Drug: PEG-IFNa 2a, Drug: RibavirinLPV/r + selected NRTIs for 26 weeks, followed by LPV/r monotherapy and anti HCV drugs for 48 weeks. All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs. |
| B | Active comparator | Drug: LPV/r, Drug: Nucleoside Reverse Transcriptase Inhibitors, Drug: PEG-IFNa 2a, Drug: RibavirinLPV/r+ selected NRTIs for 24 weeks, followed by the same HAART and anti-HCV drugs for 48 weeks. At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decision. All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is >18 years old
- Subject has given written informed consent
- Serologic evidence of HIV infection by HIV antibody and HIV-RNA detection
- Serologic evidence of HCV infection by HCV antibody and HCV-RNA detection
- Subject is naive for HIV and HCV therapy
Key exclusion criteria (14 listed)
- Subject is HbsAg positive
- Subject has cirrhosis score Child-Pugh B/C, no previous hepatic decompensation
- Subject has HIV-related thrombocytopenia (Platelets count < 50.000 mmc)
- Subject has neutrophils count < 1500/mmc
- Subject has Hb value < 9 g/dL at screening and <11 g/dL at randomization
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 |
|---|---|---|
| LPV/rLopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B) | Drug | A, B |
| Nucleoside Reverse Transcriptase InhibitorsNRTIs for 26 weeks (A) or 24 weeks (B) | Drug | A, B |
| PEG-IFNa 2aPEG-IFNa 2a 180 mcg/week (48 weeks) | Drug | A, B |
| RibavirinRibavirin 1-1.2 g/day (48 weeks) | Drug | A, B |
Primary outcome
To assess if the combination of LPV/r monotherapy in association with
Time frame: 18 months
anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional
Time frame: 18 months
toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin
Time frame: 18 months
in patients naïve for HIV and HCV
Time frame: 18 months
3 secondary outcomes
To assess if LPV/r monotherapy during the HCV treatment
Time frame: 18 and 24 months
is associated with anti HIV efficacy and a better patient satisfaction
Time frame: 18 and 24 months
vs optimized HAART.
Time frame: 18 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Adriano Lazzarin, MD principal investigator
IRCCS San Raffaele Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LPV/r, Nucleoside Reverse Transcriptase Inhibitors and PEG-IFNa 2a in people with HIV Infections and Hepatitis C, run by IRCCS San Raffaele at 1 site in Italy.
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 9 inclusion and 14 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 6 Feb 2009. 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 Italy. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriano Lazzarin, MD (+39/02/26437939, adriano.lazzarin@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if the combination of LPV/r monotherapy in association with (time frame: 18 months). The study lists 4 primary outcomes in all. 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 6 Feb 2009.