NCT02934022

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

Adding Maraviroc to the HAART Regimen of HIV-infected Patients Who Are Well Controlled, and the Effect on CD4 Lymphocyte Counts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Southern California Institute for Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• HIV Infection

Interventions

Type	Name	Description
DRUG	Maraviroc	150 mg tablets, two or 4 tablets once daily (dependent upon concommitant medications)

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2016-10-14
• Last updated: 2016-10-14

Locations

1 site across 1 country: United States