HIV InfectionPhase 3MONARKNCT00234923
Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients
A Phase 3 study testing lopinavir/ritonavir and lamivudine/zidovudine in people with HIV Infection, run by Abbott.
Trial summary
The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- lopinavir/ritonavir and lamivudine/zidovudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Antiretroviral naïve
- HIV RNA <100,000 copies/mL
- CD4 cell count >100 cells/mL at screening
- with Karnofsky Score > 70
- If female,
- non-pregnant and
- not breastfeeding
- No AIDS opportunistic infection within 30 days of screening
Who cannot join
- Subject with an HIV primo-infection status
- Recent history of drug and/or alcohol abuse
- History of psychiatric illness
- If presence of the following mutations :
- in the protease : one among 32,47,48,50,82,84,90
- OR more than 3 mutations from the other points of the LPV mutation score:10,20,24,46,53,54,63,71
Show all 11Show fewer
- in the reverse transcriptase : 215 or 184.
- If abnormal laboratory results such as :
- Hb<8 g/dl
- Absolute neutrophil count<750 cells/µl
- Platelet count<50 000/ml
About this study
Official title: A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Versus Lopinavir/Ritonavir in Combination With Lamivudine/Zidovudine in Antiretroviral Naïve Patients
The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm
- Conditions
- HIV Infection
- Being tested
- lopinavir/ritonavir, lamivudine/zidovudine
- Keywords
- HIV Infection, Kaletra, Lopinavir, Ritonavir, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lopinavir/ritonavirDrug
Also called ABT-378, Kaletra
400 mg lopinavir/ 100 mg ritonavir, BID
lamivudine/zidovudineDrug
300mg lamivudine/150mg zidovudine, BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Kaletra Monotherapy: lopinavir/ritonavir Receives: Drug: lopinavir/ritonavir |
| 2 | Active comparator | Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine Receives: Drug: lopinavir/ritonavir; Drug: lamivudine/zidovudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiviral efficacy by HIV RNA
Measured: 48 Weeks
Secondary outcomes (2)
Arm comparisons: CD4 evolution, occurrence of HIV protease and RT mutation, occurrence of AIDS clinical events, safety of NRTI-sparing vs. a PI with 2 NRTIs regimen: clinical and biological tolerance, patient's adherence and quality of life.
Measured: 48 weeks
To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startAug 2003
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234923
- Sponsor's protocol ID
- FRAN-03-001
- Other IDs
- EUDRACT: 2004-816-24, MONARK
- Acronym
- MONARK
- Status last verified
- Apr 2008
- First submitted
- 13 Sep 2005
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Tran TA, Ghosn J, Avettand-Fenoel V, Hendel-Chavez H, de Goer de Herve MG, Cohen-Codar I, Rouzioux C, Delfraissy JF, Taoufik Y. Residual HIV-1 replication may impact immune recovery in patients on first-line lopinavir/ritonavir monotherapy. J Antimicrob Chemother. 2015 Sep;70(9):2627-31. doi: 10.1093/jac/dkv138. Epub 2015 May 28.
PubMed 26023212Ghosn J, Flandre P, Cohen-Codar I, Girard PM, Chaix ML, Raffi F, Dellamonica P, Ngovan P, Norton M, Delfraissy JF; MONARK Study Group. Long-term (96-week) follow-up of antiretroviral-naive HIV-infected patients treated with first-line lopinavir/ritonavir monotherapy in the MONARK trial. HIV Med. 2010 Feb;11(2):137-42. doi: 10.1111/j.1468-1293.2009.00752.x. Epub 2009 Aug 13.
PubMed 19682100
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Versus Lopinavir/Ritonavir in Combination With Lamivudine/Zidovudine in Antiretroviral Naïve Patients
- ClinicalTrials.gov ID
- NCT00234923
- Acronym / sponsor ID
- MONARK / FRAN-03-001
- Conditions
- HIV Infection
- Keywords
- HIV Infection, Kaletra, Lopinavir, Ritonavir, Treatment Naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Feb 2007 (actual)
- First posted
- 10 Oct 2005 (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 pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: lopinavir/ritonavirKaletra Monotherapy: lopinavir/ritonavir |
| 2 | Active comparator | Drug: lopinavir/ritonavir, Drug: lamivudine/zidovudineKaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Antiretroviral naïve
- HIV RNA <100,000 copies/mL
- CD4 cell count >100 cells/mL at screening
- with Karnofsky Score > 70
- If female,
Key exclusion criteria (11 listed)
- Subject with an HIV primo-infection status
- Recent history of drug and/or alcohol abuse
- History of psychiatric illness
- If presence of the following mutations :
- If abnormal laboratory results such as :
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: ABT-378, Kaletra400 mg lopinavir/ 100 mg ritonavir, BID | Drug | 1, 2 |
| lamivudine/zidovudine300mg lamivudine/150mg zidovudine, BID | Drug | 2 |
Primary outcome
Antiviral efficacy by HIV RNA
Time frame: 48 Weeks
2 secondary outcomes
Arm comparisons: CD4 evolution, occurrence of HIV protease and RT mutation, occurrence of AIDS clinical events, safety of NRTI-sparing vs. a PI with 2 NRTIs regimen: clinical and biological tolerance, patient's adherence and quality of life.
Time frame: 48 weeks
To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety
Time frame: 96 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 3 Apr 2008.
- Derived from this study: PubMed 26023212Tran TA, Ghosn J, Avettand-Fenoel V, Hendel-Chavez H, de Goer de Herve MG, Cohen-Codar I, Rouzioux C, Delfraissy JF, Taoufik Y. Residual HIV-1 replication may impact immune recovery in patients on first-line lopinavir/ritonavir monotherapy. J Antimicrob Chemother. 2015 Sep;70(9):2627-31. doi: 10.1093/jac/dkv138. Epub 2015 May 28.
- Derived from this study: PubMed 19682100Ghosn J, Flandre P, Cohen-Codar I, Girard PM, Chaix ML, Raffi F, Dellamonica P, Ngovan P, Norton M, Delfraissy JF; MONARK Study Group. Long-term (96-week) follow-up of antiretroviral-naive HIV-infected patients treated with first-line lopinavir/ritonavir monotherapy in the MONARK trial. HIV Med. 2010 Feb;11(2):137-42. doi: 10.1111/j.1468-1293.2009.00752.x. Epub 2009 Aug 13.
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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.
Global Medical Information study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lopinavir/ritonavir and lamivudine/zidovudine in people with HIV Infection, run by Abbott.
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 8 inclusion and 11 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 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Antiviral efficacy by HIV RNA (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 NCT00234923, which also lists 2 linked publications.
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 3 Apr 2008.