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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02934022

Enrollment

Registered

2016-10-14

Start date

2012-06-30

Completion date

2014-12-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Maraviroc, HAART regimen, Immunologic response

Brief 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.

Interventions

DRUGMaraviroc

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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. -

Design outcomes

Primary

Measure	Time frame
Change in absolute CD4 lymphocyte count after addition of maraviroc for 12 months to the subject's current highly active antiretroviral therapy (HAART) regimen.	one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026