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

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.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HAART Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
HAART+ Bevacizumab Injection Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3

Participant Flow:   Overall Study
    HAART   HAART+ Bevacizumab Injection
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
HAART Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
HAART+ Bevacizumab Injection Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Total Total of all reporting groups

Baseline Measures
   HAART   HAART+ Bevacizumab Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   7   7   14 
>=65 years   0   0   0 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 27 
 (24 to 32) 
 35 
 (29 to 39) 
 30.5 
 (24.7 to 38.2) 
Gender 
[Units: Participants]
     
Female   0   1   1 
Male   7   6   13 
Region of Enrollment 
[Units: Participants]
     
Mexico   7   7   14 


  Outcome Measures

1.  Primary:   Number of Participants With Complete Response   [ Time Frame: 12 months ]

2.  Secondary:   Safety   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: Gustavo Reyes-Teran
Organization: Centro de Investigación en. Enfermedades Infecciosas
phone: 52 55 56667985
e-mail: gustavo.reyesteran@gmail.com


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

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