HIV InfectionsPhase 4KALMARNCT01068873
Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)
A Phase 4 study testing lopinavir/ritonavir plus maraviroc in people with HIV Infections, run by Temple University at 1 site in United States.
Trial summary
The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- lopinavir/ritonavir plus maraviroc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient has signed and dated approved informed consent form.
- There is confirmed laboratory diagnosis of HIV infection (positive ELISA HIV antibody test confirmed by Western blot, p24 antigen assay, quantitative HIV-1 RNA assay, or HIV culture).
- The patient is at least 18 years of age.
- ART-naïve, lopinavir/ritonavir susceptible on genotypic testing, CCR5-tropic virus on Trofile testing (ESTA).
- Negative pregnancy test within 72 hours prior to start of study for women of childbearing potential.
- Females of childbearing potential and males must utilize effective barrier contraception.
- HIV RNA greater than 1,000 copies per mL at entry.
- Liver enzymes (AST, ALT) < 3 times the upper limit of normal.
Who cannot join
- Patients who are pregnant or breast-feeding.
- Active alcohol or substance abuse sufficient, in the Investigator's opinion that makes compliance to the study protocol unlikely.
- Suspected or active HIV-related opportunistic infection or condition requiring acute therapy within 30 days of entry into the trial.
- Patients on therapy for hepatitis B.
- Patients with hepatitis B surface antigen, or any evidence of active hepatitis B such as positive hepatitis B DNA and/or presence of hepatitis e antigen or e antibody.
- Acute hepatitis B or C within 60 days of entry.
Show all 13Show fewer
- Patients harboring preexistent co-receptor CXCR4 tropic or dual-or mixed-tropic HIV.
- Patients harboring HIV resistant to lopinavir/ritonavir on genotypic testing.
- The presence of decompensated heart failure, myocardial infarction within 1 year, bypass surgery, severe vascular disease, or active hepatobiliary disease.
- Concomitant use of rifampin, ergot derivatives (i.e. dihydroergotamine, ergotamine), cisapride, lovastatin, simvastatin, triazolam, orally administered midazolam, carbamazepine, phenytoin, St. John's wort, ketoconazole, itraconazole, clarithromycin, telithromycin, amiodarone, bepridil, flecainide, propafenone, quinidine, voriconazole or nefazodone.
- Patients with concomitant diagnosis of malignancy or cancer other than basal cell carcinoma within the past 5 years.
- Concomitant use of investigational agents including the use of any investigational vaccines.
- Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study, or unable to comply with the dosing requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple General Internal Medicine
Philadelphia, Pennsylvania, 19140
About this study
Official title: Kaletra and Maraviroc in Antiretroviral Therapy-Naïve Patients - KALMAR Study -Version 1.0 Amendment 2
The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty patients will be enrolled and studied for 48 weeks.
Read the detailed description
As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options. This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhibitor class which is thought to have long-term toxicity. This is a non-randomized, open label trial in participants meeting entry requirements.
Participants will be evaluated at screening, baseline,and weeks 4, 8, 12, 24, 36, and 48 to include clinical assessments as well as laboratory assessments.
An interim analysis will be performed when all patients have reached the week 24 visit.
- Conditions
- HIV Infections
- Being tested
- lopinavir/ritonavir plus maraviroc
- Keywords
- HIV, Protease Inhibitor, CCR5 Co-receptor Antagonist, 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/ritonavir plus maravirocDrug
Also called Lopinavir/ritonavir (Kaletra), Maraviroc (Selzentry), Nucleoside sparing regimen
Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
| Study group | Role | What they receive |
|---|---|---|
| open label single arm | Experimental | Drug: lopinavir/ritonavir plus maraviroc Receives: Drug: lopinavir/ritonavir plus maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Proportion of Participants With HIV RNA Levels <50 and < 400 Copies/mL.
Measured: week 48
Secondary outcomes (6)
Number of Participants With HIV RNA < 50 and <400 Copies/ml.
Measured: week 24
Assess the Proportion of Participants at Study Termination With VL < 50 Copies/ml.
Measured: week 48
Determine the Time to Viral Suppression (VL < 50 Copies/ml).
Measured: 48 weeks
Determine the Median Change in VL From Baseline to Week 24, to Week 48 and to Study Termination.
Measured: week 24, week 48
Assess the Changes in CD4+ T Cell Count.
Measured: week 24, 48
Assess Development of HIV Resistance Mutations and in HIV Co-receptor Tropism Changes in Participants Who Develop Virologic Rebound.
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Pfizer
- Responsible party
- Sponsor
- Investigators
- Mary van den Berg-Wolf, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068873
- Sponsor's protocol ID
- Temple IRB 12848
- Acronym
- KALMAR
- Status last verified
- Oct 2020
- First submitted
- 12 Feb 2010
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaletra and Maraviroc in Antiretroviral Therapy-Naïve Patients - KALMAR Study -Version 1.0 Amendment 2
- ClinicalTrials.gov ID
- NCT01068873
- Acronym / sponsor ID
- KALMAR / Temple IRB 12848
- Conditions
- HIV Infections
- Keywords
- HIV, Protease Inhibitor, CCR5 Co-receptor Antagonist, treatment naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Abbott, Pfizer
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Feb 2010 (estimated)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty patients will be enrolled and studied for 48 weeks.
Detailed description
As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options. This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhibitor class which is thought to have long-term toxicity. This is a non-randomized, open label trial in participants meeting entry requirements.
Participants will be evaluated at screening, baseline,and weeks 4, 8, 12, 24, 36, and 48 to include clinical assessments as well as laboratory assessments.
An interim analysis will be performed when all patients have reached the week 24 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label single arm | Experimental | Drug: lopinavir/ritonavir plus maravirocDrug: lopinavir/ritonavir plus maraviroc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient has signed and dated approved informed consent form.
- There is confirmed laboratory diagnosis of HIV infection (positive ELISA HIV antibody test confirmed by Western blot, p24 antigen assay, quantitative HIV-1 RNA assay, or HIV culture).
- The patient is at least 18 years of age.
- ART-naïve, lopinavir/ritonavir susceptible on genotypic testing, CCR5-tropic virus on Trofile testing (ESTA).
- Negative pregnancy test within 72 hours prior to start of study for women of childbearing potential.
Key exclusion criteria (13 listed)
- Patients who are pregnant or breast-feeding.
- Active alcohol or substance abuse sufficient, in the Investigator's opinion that makes compliance to the study protocol unlikely.
- Suspected or active HIV-related opportunistic infection or condition requiring acute therapy within 30 days of entry into the trial.
- Patients on therapy for hepatitis B.
- Patients with hepatitis B surface antigen, or any evidence of active hepatitis B such as positive hepatitis B DNA and/or presence of hepatitis e antigen or e antibody.
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/ritonavir plus maravirocAlso: Lopinavir/ritonavir (Kaletra), Maraviroc (Selzentry), Nucleoside sparing regimenLopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria. | Drug | open label single arm |
Primary outcome
Assess Proportion of Participants With HIV RNA Levels <50 and < 400 Copies/mL.
Time frame: week 48
6 secondary outcomes
Number of Participants With HIV RNA < 50 and <400 Copies/ml.
Time frame: week 24
Assess the Proportion of Participants at Study Termination With VL < 50 Copies/ml.
Time frame: week 48
Determine the Time to Viral Suppression (VL < 50 Copies/ml).
Time frame: 48 weeks
Determine the Median Change in VL From Baseline to Week 24, to Week 48 and to Study Termination.
Time frame: week 24, week 48
Assess the Changes in CD4+ T Cell Count.
Time frame: week 24, 48
Assess Development of HIV Resistance Mutations and in HIV Co-receptor Tropism Changes in Participants Who Develop Virologic Rebound.
Time frame: week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Mary van den Berg-Wolf, MD principal investigator
Temple University
1 site 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 plus maraviroc in people with HIV Infections, run by Temple University at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 2 Nov 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Proportion of Participants With HIV RNA Levels <50 and < 400 Copies/mL. (time frame: week 48). 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 2 Nov 2020.