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Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)

Primary Purpose

HIV Infections, Acquired Immunodeficiency Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lopinavir/ritonavir plus maraviroc
Sponsored by
Rodwick, Barry M., M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, HIV, AIDS, treatment experienced

Eligibility Criteria

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

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

Sites / Locations

  • Barry M. Rodwick, M. D.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

Arm Description

single arm

Outcomes

Primary Outcome Measures

Virologic response defined as viral load reduction of >/= 1 log

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2009
Last Updated
June 20, 2015
Sponsor
Rodwick, Barry M., M.D.
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00981318
Brief Title
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc
Acronym
PALM
Official Title
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
unable to enroll expected number of subjects
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rodwick, Barry M., M.D.
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Acquired Immunodeficiency Syndrome
Keywords
Acquired Immunodeficiency Syndrome, HIV, AIDS, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Arm Type
Other
Arm Description
single arm
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir plus maraviroc
Other Intervention Name(s)
Kaletra, lopinavir, Selzentry
Intervention Description
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Primary Outcome Measure Information:
Title
Virologic response defined as viral load reduction of >/= 1 log
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Assess proportion of patients with HIV-1 viral load < 48 copies
Time Frame
48 weks
Title
Assess time to loss of virologic response
Time Frame
48 weeks
Title
Assess development of resistance mutations in patients who develop rebound
Time Frame
48 weeks
Title
Compare serum lipid profile changes
Time Frame
48 weeks
Title
Assess safety and tolerability
Time Frame
48 weeks
Title
Assess degree of immune reconstitution
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry M. Rodwick, M. D.
Organizational Affiliation
Barry M. Rodwick, M. D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barry M. Rodwick, M. D.
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Assessment of Lopinavir/Ritonavir and Maraviroc

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