Pentoxifylline and Combination Antiretroviral Therapy to Improve Blood Vessel Function in HIV-Infected People

NCT00864916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-05-12

Study results available
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Summary

People infected with HIV have a greater risk of developing cardiovascular disease than people not infected with HIV. This may be due to increased inflammation in the blood vessels. This study will determine whether an anti-inflammatory drug, pentoxifylline, in combination with antiretroviral medications, is more effective at improving blood vessel function and reducing inflammation than antiretroviral medications alone in people infected with HIV.

Conditions

Interventions

DRUG

Combination antiretroviral therapy (cART)

Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)

DRUG

Pentoxifylline

Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks.

DRUG

Placebo

Participants will receive placebo three times per day for 48 weeks.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Indiana University

    lead OTHER

Principal Investigators

  • Samir K. Gupta, MD, MS · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864916 on ClinicalTrials.gov