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

NCT01068873

Last updated date
Study Location
Temple General Internal Medicine
Philadelphia, Pennsylvania, 19140, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)
Official Title  ICMJE Kaletra and Maraviroc in Antiretroviral Therapy-Naïve Patients - KALMAR Study -Version 1.0 Amendment 2
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: open label single arm
Drug: lopinavir/ritonavir plus maraviroc
Intervention: Drug: lopinavir/ritonavir plus maraviroc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 5, 2014)
1
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2010)
20
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01068873
Other Study ID Numbers  ICMJE Temple IRB 12848
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE
  • Abbott
  • Pfizer
Investigators  ICMJE
Principal Investigator:Mary van den Berg-Wolf, MDTemple University
PRS Account Temple University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP