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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Samir Gupta, Indiana University
ClinicalTrials.gov Identifier:
NCT00796822
First received: November 21, 2008
Last updated: May 20, 2013
Last verified: May 2013
Results First Received: March 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
Cardiovascular Diseases
Atherosclerosis
Interventions: Drug: Pentoxifylline
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study recruitment, enrollment, and follow-up assessments were performed from May 2009 through October 2011, at the HIV outpatient clinics of the Indiana University Health medical system.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Potential participants underwent a screening visit to evaluate eligibility within 21 days of randomization.

Reporting Groups
  Description
Pentoxifylline

Participants will receive pentoxifylline.

Pentoxifylline : 400 mg three times a day for 8 weeks

Placebo

Participants will receive placebo.

Placebo : One pill three times a day for 8 weeks


Participant Flow:   Overall Study
    Pentoxifylline     Placebo  
STARTED     13     13  
COMPLETED     10     13  
NOT COMPLETED     3     0  
Lost to Follow-up                 2                 0  
Adverse Event                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pentoxifylline

Participants will receive pentoxifylline.

Pentoxifylline : 400 mg three times a day for 8 weeks

Placebo

Participants will receive placebo.

Placebo : One pill three times a day for 8 weeks

Total Total of all reporting groups

Baseline Measures
    Pentoxifylline     Placebo     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     13     26  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34  ± 10.9     40  ± 11.6     37  ± 11.5  
Gender  
[units: participants]
     
Female     2     5     7  
Male     11     8     19  
Region of Enrollment  
[units: participants]
     
United States     13     13     26  



  Outcome Measures

1.  Primary:   Change in Flow-mediated Dilation of the Brachial Artery   [ Time Frame: Measured at baseline and Week 8 ]

2.  Secondary:   Immunologic Parameters (i.e., Activated CD8 Cell Percentage, CD4 Cell Count)   [ Time Frame: Measured at baseline and Weeks 4 and 8 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Inflammatory Biomarkers (i.e., MCP-1, sVCAM-1, IP-10, MMP-9, TIMP-1, PAI-1 Active, hsCRP)   [ Time Frame: Measured at baseline and Weeks 4 and 8 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Metabolics (i.e., Fasting Lipid Profile, Glucose, Insulin)   [ Time Frame: Measured at baseline and Weeks 4 and 8 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Safety and Tolerability   [ Time Frame: Measured at Weeks 4 and 8 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Samir K. Gupta
Organization: Indiana University School of Medicine
phone: 317-274-7926
e-mail: sgupta1@iu.edu


No publications provided by Indiana University

Publications automatically indexed to this study:

Responsible Party: Samir Gupta, Indiana University
ClinicalTrials.gov Identifier: NCT00796822     History of Changes
Other Study ID Numbers: 614, R01HL095149-01, R01 HL095149-01
Study First Received: November 21, 2008
Results First Received: March 13, 2013
Last Updated: May 20, 2013
Health Authority: United States: Federal Government