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Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study) (KALMAR)

Primary Purpose

HIV Infections

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

lopinavir/ritonavir plus maraviroc

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Protease Inhibitor, CCR5 Co-receptor Antagonist, treatment naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Temple General Internal Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open label single arm

Arm Description

Drug: lopinavir/ritonavir plus maraviroc

Outcomes

Primary Outcome Measures

Assess Proportion of Participants With HIV RNA Levels <50 and < 400 Copies/mL.

Secondary Outcome Measures

Number of Participants With HIV RNA < 50 and <400 Copies/ml.

Assess the Proportion of Participants at Study Termination With VL < 50 Copies/ml.

Determine the Time to Viral Suppression (VL < 50 Copies/ml).

Determine the Median Change in VL From Baseline to Week 24, to Week 48 and to Study Termination.

Assess the Changes in CD4+ T Cell Count.

Assess Development of HIV Resistance Mutations and in HIV Co-receptor Tropism Changes in Participants Who Develop Virologic Rebound.

Full Information

NCT ID

NCT01068873

First Posted

February 12, 2010

Last Updated

October 8, 2020

Sponsor

Temple University

Collaborators

Abbott, Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01068873

Brief Title

Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)

Acronym

KALMAR

Official Title

Kaletra and Maraviroc in Antiretroviral Therapy-Naïve Patients - KALMAR Study -Version 1.0 Amendment 2

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Terminated

Why Stopped

Poor enrollment

Study Start Date

April 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

Collaborators

Abbott, Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV, Protease Inhibitor, CCR5 Co-receptor Antagonist, treatment naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

open label single arm

Arm Type

Experimental

Arm Description

Drug: lopinavir/ritonavir plus maraviroc

Intervention Type

Drug

Intervention Name(s)

lopinavir/ritonavir plus maraviroc

Other Intervention Name(s)

Lopinavir/ritonavir (Kaletra), Maraviroc (Selzentry), Nucleoside sparing regimen

Intervention Description

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.

Primary Outcome Measure Information:

Title

Assess Proportion of Participants With HIV RNA Levels <50 and < 400 Copies/mL.

Time Frame

week 48

Secondary Outcome Measure Information:

Title

Number of Participants With HIV RNA < 50 and <400 Copies/ml.

Time Frame

week 24

Title

Assess the Proportion of Participants at Study Termination With VL < 50 Copies/ml.

Time Frame

week 48

Title

Determine the Time to Viral Suppression (VL < 50 Copies/ml).

Time Frame

48 weeks

Title

Determine the Median Change in VL From Baseline to Week 24, to Week 48 and to Study Termination.

Time Frame

week 24, week 48

Title

Assess the Changes in CD4+ T Cell Count.

Time Frame

week 24, 48

Title

Assess Development of HIV Resistance Mutations and in HIV Co-receptor Tropism Changes in Participants Who Develop Virologic Rebound.

Time Frame

week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary van den Berg-Wolf, MD

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Temple General Internal Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

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Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)

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