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Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity

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ClinicalTrials.gov Identifier: NCT01296815
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kaposi´s Sarcoma
Intervention Drug: Bevacizumab
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HAART HAART+ Bevacizumab Injection
Hide Arm/Group Description Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Period Title: Overall Study
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title HAART HAART+ Bevacizumab Injection Total
Hide Arm/Group Description Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3 Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
7
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
27
(24 to 32)
35
(29 to 39)
30.5
(24.7 to 38.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
0
   0.0%
1
  14.3%
1
   7.1%
Male
7
 100.0%
6
  85.7%
13
  92.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Number of Participants With Complete Response
Hide Description Complete response will be assessed according to RECIST criteria
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HAART HAART+ Bevacizumab Injection
Hide Arm/Group Description:
Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
1 3
2.Secondary Outcome
Title Safety
Hide Description Adverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description Toxicity was graded and recorded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table)
 
Arm/Group Title HAART HAART+ Bevacizumab Injection
Hide Arm/Group Description Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3 Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
All-Cause Mortality
HAART HAART+ Bevacizumab Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HAART HAART+ Bevacizumab Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      1/7 (14.29%)    
Respiratory, thoracic and mediastinal disorders     
Fever * 1 [1]  0/7 (0.00%)  0 1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, DAIDS AE
[1]
A patient had fever of 39°C after 3 days of receiving the first BVZ injection and starting ART. He was hospitalized and bronchoscopy revealed Mycobacterium avium complex pulmonary disease, so he was treated with clarithromycin and ethambutol.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HAART HAART+ Bevacizumab Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Gustavo Reyes-Teran
Organization: Centro de Investigación en. Enfermedades Infecciosas
Phone: 52 55 56667985
EMail: gustavo.reyesteran@gmail.com
Layout table for additonal information
Responsible Party: Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
ClinicalTrials.gov Identifier: NCT01296815     History of Changes
Other Study ID Numbers: C41-10
First Submitted: February 15, 2011
First Posted: February 16, 2011
Results First Submitted: October 30, 2014
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015