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

NCT00864916 | Completed Phase 2 Results DMC

• 2 other identifiers: 646R01HL095149
• Study Type: interventional
• Target: 19
• 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 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

HIV; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; HIV Infections

Keywords

Endothelial Function; Pentoxifylline; Antiretroviral Therapy; Inflammation

Outcome Measures

Primary Outcomes (1)

• Flow-mediated Dilation of the Brachial Artery

  Flow-mediated dilation (% dilation of the brachial artery) at week 48

  Measured at Week 48

Study Arms (2)

1

EXPERIMENTAL

Participants will receive pentoxifylline and combination antiretroviral therapy (cART).

Drug: Combination antiretroviral therapy (cART); Drug: Pentoxifylline

2

ACTIVE COMPARATOR

Participants will receive placebo and cART.

Drug: Combination antiretroviral therapy (cART); Drug: Placebo

Interventions

Combination antiretroviral therapy (cART) DRUG

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.)

1; 2

Pentoxifylline DRUG

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

1

Placebo DRUG

Participants will receive placebo three times per day for 48 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
• Has not received any antiretroviral therapies in the 6 months before screening
• Participant is planning to initiate cART, per the primary HIV caregiver (there is no CD4 or HIV-1 RNA level criteria)

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 ULN in the 28 days before screening or at the screening visit
• Fever, defined as a temperature greater than or equal to 38.0 degrees Celsius (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)

Infectious Diseases Research Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; HIV Infections; Inflammation

Interventions

Antiretroviral Therapy, Highly Active; Pentoxifylline

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Samir K. Gupta, MD
• 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: March 17, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 12, 2014
• Results First Posted: April 16, 2014

Record last verified: 2014-04

Locations

US (1)