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Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)

This study has been terminated.
(unable to enroll expected number of subjects)
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Barry M. Rodwick, M. D., Rodwick, Barry M., M.D.
ClinicalTrials.gov Identifier:
NCT00981318
First received: September 19, 2009
Last updated: June 20, 2015
Last verified: June 2015
  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: 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 Barry M. Rodwick, M. D., Rodwick, Barry M., M.D.:

Primary Outcome Measures:
  • Virologic response defined as viral load reduction of >/= 1 log [ Time Frame: 48 weeks ]

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

Enrollment: 3
Study Start Date: December 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Florida
Barry M. Rodwick, M. D.
Safety Harbor, Florida, United States, 34695
Sponsors and Collaborators
Rodwick, Barry M., M.D.
Abbott
Investigators
Principal Investigator: Barry M. Rodwick, M. D. Barry M. Rodwick, M. D.
  More Information

Responsible Party: Barry M. Rodwick, M. D., Principal Investigator, Rodwick, Barry M., M.D.
ClinicalTrials.gov Identifier: NCT00981318     History of Changes
Other Study ID Numbers: Rodwick01
Study First Received: September 19, 2009
Last Updated: June 20, 2015

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

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Maraviroc
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
CCR5 Receptor Antagonists

ClinicalTrials.gov processed this record on July 19, 2017