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

NCT02934022 | Completed

• 1 other identifier: WS719742
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

Maraviroc; HAART regimen; Immunologic response

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Maraviroc

OTHER

Drug: Maraviroc

Interventions

Maraviroc DRUG

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

Also known as: Selzentry

Maraviroc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead
• Pfizer: collaborator

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephen M. Berman, MD, PhD

  VA Long Beach Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: October 14, 2016
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

US (1)