Evaluating the Effectiveness of Pentoxifylline at Improving Blood Vessel Function in HIV-infected People Not Receiving Antiretroviral Medications

NCT00796822 | Completed Phase 2 Results DMC

• 2 other identifiers: 614R01HL095149
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 brought on by either the HIV infection itself or the use of antiretroviral medications to treat HIV infection. This study will evaluate an anti-inflammatory drug, pentoxifylline, to determine whether it improves blood vessel function and reduces inflammation in people infected with HIV who are not currently receiving antiretroviral medications.

Conditions

HIV; Cardiovascular Diseases; Atherosclerosis

Keywords

Endothelial Function; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in Flow-mediated Dilation of the Brachial Artery

  Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.

  Measured at baseline and Week 8

Secondary Outcomes (1)

• Change in Soluble TNF-Receptor I Levels

  Measured at baseline and Week 8

Study Arms (2)

1

EXPERIMENTAL

Participants will receive pentoxifylline.

Drug: Pentoxifylline

2

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

Pentoxifylline DRUG

400 mg three times a day for 8 weeks

1

Placebo DRUG

One pill three times a day for 8 weeks

2

Eligibility Criteria

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

You may qualify if:

• Documentation of HIV infection with a positive HIV enzyme-linked immunosorbent assay (ELISA) test and confirmatory western blot test
• CD4 cell count greater than 350/µL at the time of screening
• Has not received any antiretroviral therapies in the 6 months before screening
• No anticipated need for any antiretroviral therapies during the course of this study, as determined by the principal investigator or by the participant's HIV caregiver
• Note: There is no HIV-1 RNA level eligibility criterion.

You may not qualify if:

• Incarceration at the time of screening or at any study visit
• Diagnosed vascular disease, including history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease
• History of bleeding diathesis, gastrointestinal ulceration or bleeding, cerebrovascular aneurysm or bleeding, or retinal hemorrhage
• Known or suspected cancer requiring systemic treatment in the 6 months before screening
• History of migraine headaches
• History of Raynaud's phenomenon
• History of cardiac arrhythmias or cardiomyopathy
• History of hypothyroidism or hyperthyroidism, even if treated
• Known allergy or intolerance to nitroglycerin
• History of carotid bruits
• Creatinine clearance less than 50 mL/min, using the Cockcroft-Gault equation and a serum creatinine level measured in the 28 days before screening or at the screening visit
• Hemoglobin less than 9.0 mg/dL in the 28 days before screening or at the screening visit
• Alanine aminotransferase (ALT) level or aspartate aminotransferase (AST) greater than three times the upper limit of normal (ULN) in the 28 days before screening or at the screening visit
• Total bilirubin greater than 2.5 times the ULN in the 28 days before screening or at the screening visit
• Fever, defined as a temperature greater than or equal to 38.0 C in the 48 hours before screening. Fever in the 48 hours before each study visit will require postponement of that study visit until the participant's temperature has been lower than 38.0 C for at least 48 hours; fevers continuing past the allowed study visit timeframe will result in study discontinuation.

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Indiana Clinical Research Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Gupta SK, Mi D, Dube MP, Saha CK, Johnson RM, Stein JH, Clauss MA, Mather KJ, Desta Z, Liu Z. Pentoxifylline, inflammation, and endothelial function in HIV-infected persons: a randomized, placebo-controlled trial. PLoS One. 2013 Apr 9;8(4):e60852. doi: 10.1371/journal.pone.0060852. Print 2013.

  PMID: 23593327 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Inflammation

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Samir K. Gupta
• Organization: Indiana University School of Medicine

sgupta1@iu.edu

317-274-7926

Study Officials

• Samir K. Gupta, MD, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 28, 2017
• Results First Posted: May 17, 2013

Record last verified: 2017-10

Locations

US (1)