Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844519
• Other study ID #: HIVCADRFA
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2009
• Last updated: July 16, 2014
• Start date: January 2010
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cardiovascular Disease
• Cardiovascular Diseases
• HIV Infection
• HIV Infections
• Infection
• Inflammation

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI), Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in FMD	endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery	Baseline, 24 weeks	No