Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)

Rodwick, Barry M., M.D.

Status and phase: Terminated; Phase 4

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome

Treatments: Drug: lopinavir/ritonavir plus maraviroc

Study type: Interventional

Funder types: Industry

Identifiers

NCT00981318

Rodwick01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

Other group

Description:

single arm

Treatment:

Drug: lopinavir/ritonavir plus maraviroc