Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-12-31

Brief Summary

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Many patients on Highly Active Antiretroviral Therapy (HAART) are able to achieve a sustained response with viral loads becoming undetectable and staying undetectable, but do not have an increase in their CD4 counts to levels greater than 500. Adding maraviroc to the treatment regimen of these patients may result in an increase in their CD4 counts. As the patient would be continuing their prior regimen, they will likely continue with full control of viral replication.

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Detailed Description

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This is a prospective, open-label, non-controlled, non-randomized, single center study of the effect of adding the antiretroviral Maraviroc to the antiretroviral treatment regimen (HAART)of patients who have achieved a sustained virologic response to HAART but have had a sub-adequate immunologic response to treatment. Patients who have had a full virologic response (as defined by HIV-1 viral loads of \< 48 copies/mL) for 12 months or more are defined as having a sub-adequate immunologic response if their CD4 lymphocyte count has not gone above 500.

This pilot study will contain up to 30 patients who will be followed over a period of 12 months starting from the date of enrollment and addition of maraviroc to their current highly active antiretroviral therapy regimen. The main outcome to be followed is the CD4 lymphocyte counts at baseline and after 12 months of treatment with the addition of maraviroc.

Conditions

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HIV Infection

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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Maraviroc

Group Type OTHER

Maraviroc

Intervention Type DRUG

150 mg tablets, two or 4 tablets once daily (dependent upon concommitant medications)

Interventions

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Maraviroc

150 mg tablets, two or 4 tablets once daily (dependent upon concommitant medications)

Intervention Type DRUG

Other Intervention Names

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Selzentry

Eligibility Criteria

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Inclusion Criteria

1. HIV-1 positive.
2. Receiving highly active antiretroviral therapy (HAART).
3. HIV-1 viral load of \< 48 copies for 12 months or more.
4. CD4 lymphocyte count that has not gone above 500. -

Exclusion Criteria

1. Severe hepatic impairment (cirrhosis) or active Hepatitis C with liver transaminases \> 5 times normal.
2. Severe renal impairment (creatinine clearance \< 30 ml/min) or end-stage renal disease (ESRD) who are taking potent CYP3A4 inhibitors or inducers.
3. Receiving certain necessary medications that have the potential for serious drug-drug interactions with maraviroc. -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No