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

NCT01068873 | Terminated Phase 4 Results

• 1 other identifier: Temple IRB 12848
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  week 48

Secondary Outcomes (6)

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

  week 24

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

  week 48

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

  48 weeks

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

  week 24, week 48

• Assess the Changes in CD4+ T Cell Count.

  week 24, 48

Study Arms (1)

open label single arm

EXPERIMENTAL

Drug: lopinavir/ritonavir plus maraviroc

Drug: lopinavir/ritonavir plus maraviroc

Interventions

lopinavir/ritonavir plus maraviroc DRUG

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.

Also known as: Lopinavir/ritonavir (Kaletra), Maraviroc (Selzentry), Nucleoside sparing regimen

open label single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead
• Abbott: collaborator
• Pfizer: collaborator

Study Sites (1)

Temple General Internal Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Lopinavir; Ritonavir; Maraviroc; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles

Results Point of Contact

• Title: Lisa Landsberg
• Organization: Lewis Katz School of Medicine at Temple University

lisa.landsberg@temple.edu

12157077303

Study Officials

• Mary van den Berg-Wolf, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 15, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 2, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-10

Locations

US (1)