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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern California Institute for Research and Education
• Collaborator: Pfizer
• Treatments: Maraviroc

Criteria

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. -