Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)

June 20, 2015 updated by: Barry M. Rodwick, M. D., Rodwick, Barry M., M.D.

Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients

This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Safety Harbor, Florida, United States, 34695
        • Barry M. Rodwick, M. D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV viral load > 1,000 on current antiviral medications
  • No resistance to study medications
  • Over 18 years of age

Exclusion Criteria:

  • Hepatitis B co-infection
  • Pregnancy
  • Previous therapy with either of the study medications
  • Ongoing substance abuse
  • Significant history of other physical disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
single arm
Drug: lopinavir/ritonavir plus maraviroc
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Other Names:
  • Kaletra
  • Selzentry
  • lopinavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Virologic response defined as viral load reduction of >/= 1 log
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess proportion of patients with HIV-1 viral load < 48 copies
Time Frame: 48 weks
48 weks
Assess time to loss of virologic response
Time Frame: 48 weeks
48 weeks
Assess development of resistance mutations in patients who develop rebound
Time Frame: 48 weeks
48 weeks
Compare serum lipid profile changes
Time Frame: 48 weeks
48 weeks
Assess safety and tolerability
Time Frame: 48 weeks
48 weeks
Assess degree of immune reconstitution
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rodwick, Barry M., M.D.

Collaborators

Abbott

Investigators

  • Principal Investigator: Barry M. Rodwick, M. D., Barry M. Rodwick, M. D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 19, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 20, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rodwick01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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