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Trial record 30 of 33 for:    " November 12, 2008":" December 12, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT00796822
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : May 17, 2013
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, Indiana University

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
Enrollment 26
Recruitment Details 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 Potential participants underwent a screening visit to evaluate eligibility within 21 days of randomization.
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description

Participants will receive pentoxifylline.

Pentoxifylline : 400 mg three times a day for 8 weeks

Participants will receive placebo.

Placebo : One pill three times a day for 8 weeks

Period Title: Overall Study
Started 13 13
Completed 10 13
Not Completed 3 0
Reason Not Completed
Lost to Follow-up             2             0
Adverse Event             1             0
Arm/Group Title Pentoxifylline Placebo Total
Hide Arm/Group Description

Participants will receive pentoxifylline.

Pentoxifylline : 400 mg three times a day for 8 weeks

Participants will receive placebo.

Placebo : One pill three times a day for 8 weeks

Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
34  (10.9) 40  (11.6) 37  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
2
  15.4%
5
  38.5%
7
  26.9%
Male
11
  84.6%
8
  61.5%
19
  73.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Change in Flow-mediated Dilation of the Brachial Artery
Hide Description Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.
Time Frame Measured at baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of remaining participants at week 8 with evaluable vascular ultrasonography. In the Pentoxifylline group, 10 participants were evaluated at week 8 but only 9 had evaluable ultrasonography.
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description:

Participants will receive pentoxifylline.

Pentoxifylline : 400 mg three times a day for 8 weeks

Participants will receive placebo.

Placebo : One pill three times a day for 8 weeks

Overall Number of Participants Analyzed 9 13
Mean (Standard Deviation)
Unit of Measure: absolute percentage
-1.93  (3.03) -1.06  (1.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline, Placebo
Comments The sample size was determined based on a two-sample, independent, two-tailed t-test with 5% type I error. Using the results from our pilot trial, we conservatively estimated a predicted absolute change in FMD of 3.5% with PTX (assuming no change with placebo) and we assumed a common standard deviation of 2.6%. A sample size of 10 per group was estimated to provide at least 80% power to detect this effect size. Allowing for a 20% dropout rate, we planned to recruit 13 subjects per group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.53 to 3.28
Parameter Dispersion
Type: Standard Deviation
Value: 1.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Soluble TNF-Receptor I Levels
Hide Description Measure of systemic inflammation
Time Frame Measured at baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Those who had both baseline and Week 8 data available
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description:

Participants will receive pentoxifylline.

Pentoxifylline : 400 mg three times a day for 8 weeks

Participants will receive placebo.

Placebo : One pill three times a day for 8 weeks

Overall Number of Participants Analyzed 10 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
65.9  (168.97) -83.2  (137.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pentoxifylline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments There was no formal power calculation for this outcome measure as the study was powered on the primary outcome measure.
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 149.1
Confidence Interval (2-Sided) 95%
16.4 to 281.9
Parameter Dispersion
Type: Standard Deviation
Value: 151.8
Estimation Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pentoxifylline Placebo
Hide Arm/Group Description

Participants will receive pentoxifylline.

Pentoxifylline : 400 mg three times a day for 8 weeks

Participants will receive placebo.

Placebo : One pill three times a day for 8 weeks

All-Cause Mortality
Pentoxifylline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pentoxifylline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pentoxifylline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/13 (76.92%)      10/13 (76.92%)    
Blood and lymphatic system disorders     
Neutropenia   2/13 (15.38%)  2 0/13 (0.00%)  0
Endocrine disorders     
Hyperglycemia   1/13 (7.69%)  1 0/13 (0.00%)  0
Gastrointestinal disorders     
All gastrointestinal  [1]  5/13 (38.46%)  7 5/13 (38.46%)  8
General disorders     
Headache   2/13 (15.38%)  2 1/13 (7.69%)  1
Hepatobiliary disorders     
Elevated liver function tests   1/13 (7.69%)  1 1/13 (7.69%)  1
Renal and urinary disorders     
Hypokalemia   1/13 (7.69%)  1 0/13 (0.00%)  0
Hyperkalemia   0/13 (0.00%)  0 1/13 (7.69%)  1
Proteinuria   1/13 (7.69%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough *  0/13 (0.00%)  0 2/13 (15.38%)  2
Skin and subcutaneous tissue disorders     
Rash   1/13 (7.69%)  1 2/13 (15.38%)  2
Flushing   0/13 (0.00%)  0 2/13 (15.38%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Nausea, vomiting, belching, dyspepsia, diarrhea
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
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: November 28, 2017