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Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)

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ClinicalTrials.gov Identifier: NCT00981318
Recruitment Status : Terminated (unable to enroll expected number of subjects)
First Posted : September 22, 2009
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
HIV Infections Acquired Immunodeficiency Syndrome Drug: lopinavir/ritonavir plus maraviroc Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients
Study Start Date : December 2009
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 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