Pilot Assessment of Lopinavir/Ritonavir and Maraviroc

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections Acquired Immunodeficiency Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

single arm

Group Type OTHER

lopinavir/ritonavir plus maraviroc

Intervention Type DRUG

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

Interventions

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lopinavir/ritonavir plus maraviroc

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

Intervention Type DRUG

Other Intervention Names

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Kaletra lopinavir Selzentry

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No