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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir Maraviroc

U.S. FDA Resources

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 (Adult, Senior)
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


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:


HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes 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 September 29, 2016

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