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: 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 ]

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
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

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

No publications provided

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
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015