HIV InfectionsPhase 3NCT00437684
Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Patients Starting Treatment With Anti-Hepatitis C Virus (HCV) Therapy
A Phase 3 study testing LPV/r, PEG-IFNa 2a and Ribavirin 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 HIV/HCV coinfected patients. 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, PEG-IFNa 2a and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 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
- Subject has a confirmed diagnosis of HIV and HCV infection
- Subject is naive for HCV-infection treatment
- Subject has chronic hepatitis and/or subject has compensated cirrhosis (Child class A)
- Subject has a CD4+ count of > 350 cell/mmc
Show all 11Show fewer
- Subject is HIV-RNA negative during the previous six month
- Subject is on stable HAART including r/LPV for > 6 months
- Subject has genotype available at baseline and no mutations associated with resistance to PI or no virologic failure on PI treatment, defined as a confirmed HIV-RNA level>50 cp/mL after 24 weeks, > 50 cp/ml after 48 weeks, or a repeated HIV RNA level > 50 cp/mL after prior suppression of viremia to< 50 cps/mL.
- Free of any clinically significant disease (other than HIV and HCV) that would interfere with study evaluations.
- Subject 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 < 11 g/dL
Show all 19Show fewer
- Subject has creatinine value > 1.5 mg/dL
- 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)
- Subject has autoimmune hepatitis
- Prior treatment with PEG-IFN or ribavirin
- Illicit drugs abuse that in the opinion of the investigator could lead to poor compliance with the terms of the protocol (Methadone sostitution therapy 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
- Subject has uncompensated diabetes
- Subject has active opportunistic infections or major opportunistic infections during the previous 12 months
- Subject has known hypersensitivity or contraindication to study medications
- Subject has any other condition that in the opinion of the investigator will make the subject unsuitable for enrolment or will interfere with the subject participating in or completing the study
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
Anna De Bona, MD, +39/02/26437932, anna.debona@hsr.it
About this study
Official title: A Pilot, Open Label, Multicenter, Randomized Clinical Trial on Lopinavir/Ritonavir-Monotherapy vs Lopinavir/Ritonavir Plus Selected Nucs, in HIV/HCV 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 HIV/HCV coinfected patients.
Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy versus optimized HAART.
Read the detailed description
This is a pilot, randomised, open label, controlled clinical trial. All eligible patients(CD4>350, HIV RNA<50 copies and no PI mutations) will be randomized (1:1) to receive LPV/r new tabs (200/50 mg, 2 cpr BID) monotherapy (arm A) or LPV/r + selected NUCS (arm B) associated to anti-HCV therapy for 12 months. The number of subjects to recruit, in each arm of the study, is equal to 25, the total number of subjects to enrol will be 50.
- Group A: will receive LPV/r monotherapy and anti HCV drugs for 12 months.
- Group B: will receive LPV/r+ selected NUCS and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who reach an early virological response will continue anti-HCV drugs.
- Conditions
- HIV Infections, Hepatitis C
- Being tested
- LPV/r, PEG-IFNa 2a, Ribavirin, NUCS
- Keywords
- HIV/HCV, HIV and HCV coinfected patients, 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.
LPV/rDrug
200/50 mg 2 cpr bid monotherapy
PEG-IFNa 2aDrug
PEG-IFNa 2a 180 mcg/week
RibavirinDrug
Ribavirin 1-1.2 g/day
NUCSDrug
Nucleoside Reverse Transcriptase Inhibitors
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | LPV/r: LPV/r monotherapy and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who reach an early virological response will continue anti-HCV drugs. Receives: Drug: LPV/r; Drug: PEG-IFNa 2a; Drug: Ribavirin |
| B | Active comparator | LPV/r+ selected NUCS and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who reach an early virological response will continue anti-HCV drugs. Receives: Drug: LPV/r; Drug: PEG-IFNa 2a; Drug: Ribavirin; Drug: NUCS |
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 anti-HCV
Measured: 12 months
Nucs) and PEG-IFN alfa 2a +Ribavirin in patients naïve for HCV treatment
Measured: 12 months
without previous failure or detection of any mutations related to PI resistance.
Measured: 12 months
Secondary outcomes (4)
To assess if LPV/r monotherapy during the HCV treatment is associated with
Measured: 12 and 18 months
anti HIV/HCV efficacy and a better patient satisfaction vs optimized HAART.
Measured: 12 and 18 months
To assess the number and type of HIV-1 resistance mutations in patients with
Measured: 12 and 18 months
virological failure
Measured: 12 and 18 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 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
- NCT00437684
- Sponsor's protocol ID
- Kamon 2
- Other IDs
- NTC00437684
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2007
- Last updated
- 6 Feb 2009
- Results posted
- No
Publications
Hasson H, Galli L, Gallotta G, Neri V, Blanc P, D'Annunzio M, Morsica G, Sollima S, Merli M, Lazzarin A, Uberti-Foppa C. HAART simplification with lopinavir/ritonavir monotherapy in HIV/HCV co-infected patients starting anti-HCV treatment: a randomised pilot study (KaMon study). New Microbiol. 2012 Oct;35(4):469-74. Epub 2012 Oct 1.
PubMed 23109014
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
- A Pilot, Open Label, Multicenter, Randomized Clinical Trial on Lopinavir/Ritonavir-Monotherapy vs Lopinavir/Ritonavir Plus Selected Nucs, in HIV/HCV Coinfected Patients With Chronic Hepatitis C or Compensated Cirrhosis, Starting Treatment With Ribavirin and Pegylated Interferon
- ClinicalTrials.gov ID
- NCT00437684
- Acronym / sponsor ID
- Kamon 2
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- HIV/HCV, HIV and HCV coinfected patients, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 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 HIV/HCV coinfected patients.
Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy versus optimized HAART.
Detailed description
This is a pilot, randomised, open label, controlled clinical trial. All eligible patients(CD4>350, HIV RNA<50 copies and no PI mutations) will be randomized (1:1) to receive LPV/r new tabs (200/50 mg, 2 cpr BID) monotherapy (arm A) or LPV/r + selected NUCS (arm B) associated to anti-HCV therapy for 12 months. The number of subjects to recruit, in each arm of the study, is equal to 25, the total number of subjects to enrol will be 50.
- Group A: will receive LPV/r monotherapy and anti HCV drugs for 12 months.
- Group B: will receive LPV/r+ selected NUCS and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who 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: PEG-IFNa 2a, Drug: RibavirinLPV/r: LPV/r monotherapy and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who reach an early virological response will continue anti-HCV drugs. |
| B | Active comparator | Drug: LPV/r, Drug: PEG-IFNa 2a, Drug: Ribavirin, Drug: NUCSLPV/r+ selected NUCS and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who 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 (11 listed)
- Subject is >18 years old
- Subject has given written informed consent
- Subject has a confirmed diagnosis of HIV and HCV infection
- Subject is naive for HCV-infection treatment
- Subject has chronic hepatitis and/or subject has compensated cirrhosis (Child class A)
Key exclusion criteria (19 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
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/r200/50 mg 2 cpr bid monotherapy | Drug | A, B |
| PEG-IFNa 2aPEG-IFNa 2a 180 mcg/week | Drug | A, B |
| RibavirinRibavirin 1-1.2 g/day | Drug | A, B |
| NUCSNucleoside Reverse Transcriptase Inhibitors | Drug | B |
Primary outcome
To assess if the combination of LPV/r monotherapy in association with anti-HCV
Time frame: 12 months
Nucs) and PEG-IFN alfa 2a +Ribavirin in patients naïve for HCV treatment
Time frame: 12 months
without previous failure or detection of any mutations related to PI resistance.
Time frame: 12 months
4 secondary outcomes
To assess if LPV/r monotherapy during the HCV treatment is associated with
Time frame: 12 and 18 months
anti HIV/HCV efficacy and a better patient satisfaction vs optimized HAART.
Time frame: 12 and 18 months
To assess the number and type of HIV-1 resistance mutations in patients with
Time frame: 12 and 18 months
virological failure
Time frame: 12 and 18 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.
- Derived from this study: PubMed 23109014Hasson H, Galli L, Gallotta G, Neri V, Blanc P, D'Annunzio M, Morsica G, Sollima S, Merli M, Lazzarin A, Uberti-Foppa C. HAART simplification with lopinavir/ritonavir monotherapy in HIV/HCV co-infected patients starting anti-HCV treatment: a randomised pilot study (KaMon study). New Microbiol. 2012 Oct;35(4):469-74. Epub 2012 Oct 1.
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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.
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, PEG-IFNa 2a and Ribavirin 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 11 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 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 anti-HCV (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT00437684, 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 6 Feb 2009.