Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

NCT00844519 | Completed Phase 3 Results DMC

• 1 other identifier: HIVCADRFA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.

Conditions

HIV Infection; Cardiovascular Disease; Inflammation; HIV Infections

Keywords

Treatment Experienced; CCR5 receptor; maraviroc

Outcome Measures

Primary Outcomes (1)

• Percent Change in FMD

  endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery

  Baseline, 24 weeks

Study Arms (2)

Maraviroc

ACTIVE COMPARATOR

For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.

Drug: Maraviroc

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Maraviroc DRUG

For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.

Maraviroc

placebo DRUG

For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.

Placebo

Eligibility Criteria

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

You may qualify if:

• Stable antiretroviral therapy for at least 12 months
• All plasma HIV RNA levels within the past year must be below level of detection (\< 50 copies RNA/mL), although isolated single values \> 50 but \< 200 copies will be allowed.
• Screening plasma HIV RNA levels \< 50 copies RNA/mL
• \>90% adherence to therapy within the preceding 30 days, as determined by self-report
• Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

You may not qualify if:

• Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
• Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
• Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
• Concurrent or recent exposure to any immunomodulatory drugs
• Advanced liver disease or active hepatitis B or C
• Patients with systolic blood pressure \<100/70
• Starting or stopping statin therapy during the trial

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Pfizer: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections; Cardiovascular Diseases; Inflammation; Diabetes Mellitus, Insulin-Dependent, 22

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Priscilla Hsue
• Organization: University of California San Francisco

phsue@medsfgh.ucsf.edu

415-206-8257

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2014
• Last Updated: July 24, 2014
• Results First Posted: June 19, 2014

Record last verified: 2014-07

Locations

US (1)