Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	May 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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; 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