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Trial record 1 of 1 for:    22918156 [PUBMED-IDS]
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Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

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ClinicalTrials.gov Identifier: NCT00843713
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : June 10, 2015
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Priscilla Hsue, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infection
Inflammation
Cardiovascular Disease
HIV Infections
Interventions Drug: raltegravir
Drug: Placebo
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Raltegravir
Hide Arm/Group Description

For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication

raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Period Title: Overall Study
Started 30 26
Completed 30 26
Not Completed 0 0
Arm/Group Title Placebo Raltegravir Total
Hide Arm/Group Description

For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication

raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Total of all reporting groups
Overall Number of Baseline Participants 30 26 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 30 participants 26 participants 56 participants
53
(47 to 59)
54
(47 to 59)
53
(47 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 26 participants 56 participants
Female
1
   3.3%
2
   7.7%
3
   5.4%
Male
29
  96.7%
24
  92.3%
53
  94.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 26 participants 56 participants
Caucasian 19 20 39
African-American 5 3 8
Latino 2 1 3
Other 4 2 6
1.Primary Outcome
Title Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)
Hide Description Measurements in the change of brachial artery diameter from pre and post treatment.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Raltegravir
Hide Arm/Group Description:

For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication

raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Overall Number of Participants Analyzed 30 26
Median (Inter-Quartile Range)
Unit of Measure: millimeters
3.4
(2.4 to 5.1)
2.9
(2.6 to 5.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Raltegravir
Hide Arm/Group Description

For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication

raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

All-Cause Mortality
Placebo Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   1/26 (3.85%) 
Hepatobiliary disorders     
Hepatocellular Carcinoma  1 [1]  0/30 (0.00%)  1/26 (3.85%) 
Infections and infestations     
Infection  1 [2]  1/30 (3.33%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, DAIDS AE
[1]
The study MD does not believe this adverse event is related to study participation or study drug. Raltegravir has not been commonly associated with renal insufficiency.
[2]
The principal investigator and co-principal investigator do not believe this adverse event was related to study participation. In addition to HIV, the subject has diabetes mellitus which may have predisposed him to getting the spinal infection.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   1/26 (3.85%) 
Hepatobiliary disorders     
Hyperbilirubinemia  1  0/30 (0.00%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, DAIDS AE
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Priscilla Hsue, MD
Organization: University of California, San Francisco
Phone: 415-206-8257
Responsible Party: Priscilla Hsue, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00843713     History of Changes
Other Study ID Numbers: 1R01HL095130-01 ( U.S. NIH Grant/Contract )
First Submitted: February 12, 2009
First Posted: February 13, 2009
Results First Submitted: January 30, 2015
Results First Posted: June 10, 2015
Last Update Posted: December 12, 2018