Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

NCT ID: NCT00844519

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Maraviroc

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.

Group Type: ACTIVE_COMPARATOR

Maraviroc

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

Maraviroc

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.

Intervention Type: DRUG

placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Stable antiretroviral therapy for at least 12 months

2. 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.

3. Screening plasma HIV RNA levels < 50 copies RNA/mL

4. >90% adherence to therapy within the preceding 30 days, as determined by self-report

5. 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.

Exclusion Criteria

1. Ongoing or prior use of any integrase inhibitor or R5 inhibitor.

2. Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason

3. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months

4. Concurrent or recent exposure to any immunomodulatory drugs

5. Advanced liver disease or active hepatitis B or C

6. Patients with systolic blood pressure <100/70

7. Starting or stopping statin therapy during the trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

HIVCADRFA

Identifier Type: -

Identifier Source: org_study_id