Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Rodwick, Barry M., M.D..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Rodwick, Barry M., M.D.
ClinicalTrials.gov Identifier:
NCT00981318
First received: September 19, 2009
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
HIV Infections
Acquired Immunodeficiency Syndrome
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: Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients

Resource links provided by NLM:


Further study details as provided by Rodwick, Barry M., M.D.:

Primary Outcome Measures:
  • Virologic response defined as viral load reduction of >/= 1 log [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess proportion of patients with HIV-1 viral load < 48 copies [ Time Frame: 48 weks ] [ Designated as safety issue: No ]
  • Assess time to loss of virologic response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Assess development of resistance mutations in patients who develop rebound [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Compare serum lipid profile changes [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Assess safety and tolerability [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Assess degree of immune reconstitution [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lopinavir/ritonavir plus maraviroc
    lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
    Other Names:
    • Kaletra
    • lopinavir
    • Selzentry
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981318

Contacts
Contact: Barry M. Rodwick, M. D. 727-725-9931 Doc@DrRodwick.com
Contact: Tiffany D. Ross, MA CRC 727-725-9931 Tiffany@DrRodwick.com

Locations
United States, Florida
Barry M. Rodwick, M. D. Not yet recruiting
Safety Harbor, Florida, United States, 34695
Contact: Tiffany D. Ross, MA CRC    727-725-9931    Tiffany@DrRodwick.com   
Contact: Donna Bulmer    727-725-9931    Donna@DrRodwick.com   
Principal Investigator: Barry M. Rodwick, M. D.         
Barry M. Rodwick, M. D. Recruiting
Safety Harbor, Florida, United States, 34695
Contact: Barry M Rodwick, M. D.    727-725-8831    Doc@DrRodwick.com   
Contact: Tiffany D Ros, CRC    727-725-9931    Tiffany@DrRodwick.com   
Sponsors and Collaborators
Rodwick, Barry M., M.D.
Abbott
Investigators
Principal Investigator: Barry M. Rodwick, M. D. Barry M. Rodwick, M. D.
  More Information

No publications provided

Responsible Party: Barry M. Rodwick, M. D.
ClinicalTrials.gov Identifier: NCT00981318     History of Changes
Other Study ID Numbers: Rodwick01
Study First Received: September 19, 2009
Last Updated: February 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Rodwick, Barry M., M.D.:
Acquired Immunodeficiency Syndrome
HIV
AIDS
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Disease
Pathologic Processes
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 October 02, 2014