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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00796822
First Posted: November 24, 2008
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, Indiana University
Results First Submitted: March 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[Units: Participants]
 13   13   26 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13 100.0%      13 100.0%      26 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 34  (10.9)   40  (11.6)   37  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  15.4%      5  38.5%      7  26.9% 
Male      11  84.6%      8  61.5%      19  73.1% 
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 reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


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


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Samir K Gupta, MD, MS, Indiana University
ClinicalTrials.gov Identifier: NCT00796822     History of Changes
Other Study ID Numbers: 614
R01HL095149 ( U.S. NIH Grant/Contract )
First Submitted: November 21, 2008
First Posted: November 24, 2008
Results First Submitted: March 13, 2013
Results First Posted: May 17, 2013
Last Update Posted: September 29, 2017