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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: lopinavir/ritonavir plus maraviroc	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Kaletra and Maraviroc in Antiretroviral Therapy-Naïve Patients - KALMAR Study -Version 1.0 Amendment 2

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir Maraviroc

U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:

Assess proportion of participants with HIV RNA levels <50 and < 400 copies/mL. [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess proportion of participants with HIV RNA < 50 and <400 copies/ml. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Assess the proportion of participants at study termination with VL < 50 copies/ml. [ Time Frame: week 48 ] [ Designated as safety issue: No ]
Determine the time to viral suppression (VL < 50 copies/ml). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Determine the median change in VL from baseline to week 24, to week 48 and to study termination. [ Time Frame: week 24, week 48 ] [ Designated as safety issue: No ]
Assess the changes in CD4+ T cell count. [ Time Frame: week 24, 48 ] [ Designated as safety issue: No ]
Assess development of HIV resistance mutations and in HIV co-receptor tropism changes in participants who develop virologic rebound. [ Time Frame: week 48 ] [ Designated as safety issue: No ]
Assess safety and tolerability including any lipid changes. [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	April 2010
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: open label single arm Drug: lopinavir/ritonavir plus maraviroc	Drug: lopinavir/ritonavir plus maraviroc 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. Other Names: Lopinavir/ritonavir (Kaletra) Maraviroc (Selzentry) Nucleoside sparing regimen

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068873

Contacts

Contact: Mary van den Berg-Wolf, MD

215-707-1800

mvan@temple.edu

Locations

United States, Pennsylvania
Temple General Internal Medicine	Recruiting
Philadelphia, Pennsylvania, United States, 19140
Sub-Investigator: Ellen M Tedaldi, MD
Sub-Investigator: Carol Holtzman, Pharm D

Sponsors and Collaborators

Temple University

Abbott

Pfizer

Investigators

Principal Investigator:

Mary van den Berg-Wolf, MD

Temple University

More Information

No publications provided

Responsible Party:	Mary van den Berg-Wolf MD, Temple University School of Medicine
ClinicalTrials.gov Identifier:	NCT01068873 History of Changes
Other Study ID Numbers:	Temple IRB 12848
Study First Received:	February 12, 2010
Last Updated:	September 23, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Temple University:

HIV
Protease Inhibitor
CCR5 Co-receptor Antagonist
treatment naive

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir

Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013