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Completed

NCT Number: NCT00843713

Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

Recent studies suggest that HIV patients are at increased risk for cardiovascular events; however, the mechanisms underlying this increased risk remain unclear. Our group was one of the first to demonstrate that HIV infection is independently associated with accelerated atherosclerosis, as measured by carotid artery-intima media thickness (IMT), and that HIV-associated inflammation may be driving this accelerated atherosclerosis. The mechanism by which HIV disease independent of any drug-specific toxicity increases the risk of cardiovascular disease during HAART is not known. We hypothesize that even well controlled HIV infection is independently associated with cardiovascular risk and that further decreasing HIV-associated inflammation adding newer antiretroviral agents will also decrease cardiovascular risk.

We will perform a small clinical trial of approximately 50 HIV-infected patients each to study the relationship between HIV infection, inflammation, thrombosis, atherogenic lipoproteins, and measures of atherosclerosis. We propose the following specific aims: Aim 1: To determine the influence of traditional and novel markers of inflammation on endothelial function and IMT progression; Aim 2: To determine if "intensification" with raltegravir in subjects on long-term antiretroviral therapy with clinically undetectable HIV RNA levels will improve endothelial function, and to determine if this effect is mediated by alterations in inflammatory markers, lipoproteins and/or thrombotic factors. For Aim 2, subjects from 2 randomized, double-blind, placebo-controlled raltegravir intensification studies will be asked to co-enroll in this cardiovascular study.

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Key information

Conditions

HIV Infection Blood-Borne Infections Cardiovascular Disease Cardiovascular Diseases Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • CD4<350 cells/mm3 for at least one year ("immunologic non-responder") or CD4>=350 cells/mm3 for at least one year ("immunologic responder").

Exclusion criteria

  • 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

Treatment and study plan

raltegravir

Drug

For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Placebo

Drug

For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Primary outcomes

  1. Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)

    Time frame: 24 weeks

    Measurements in the change of brachial artery diameter from pre and post treatment.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Randomized, Controlled Trial Assessing the Effects of Raltegravir Intensification on Endothelial Function in Treated HIV Infection

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Feb 13, 2009
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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