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Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption

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: NCT02788175
Recruitment Status : Completed
First Posted : June 2, 2016
Results First Posted : December 16, 2019
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Intervention Biological: Entyvio (Vedolizumab)
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vedolizumab in HIV-infected Adults on cART
Hide Arm/Group Description HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
Period Title: Overall Study
Started [1] 26
Received Study Agent 20
Completed 13
Not Completed 13
Reason Not Completed
Protocol Violation             3
Withdrawal by Subject             4
Ineligible prior to study agent             6
[1]
Screened
Arm/Group Title Vedolizumab in HIV-infected Adults on cART
Hide Arm/Group Description HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
4
  15.4%
Male
22
  84.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Hispanic or Latino
3
  11.5%
Not Hispanic or Latino
23
  88.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  30.8%
White
15
  57.7%
More than one race
1
   3.8%
Unknown or Not Reported
2
   7.7%
1.Primary Outcome
Title Number of Grade 2 or Higher Related Adverse Events
Hide Description The primary endpoint was the number of grade 2 or higher adverse events, including serious adverse events, that were probably or definitely related to vedolizumab.
Time Frame From the start of the initial infusion until up to 72 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included all subjects who received at least one infusion of vedolizumab
Arm/Group Title Vedolizumab in HIV-infected Adults on cART
Hide Arm/Group Description:
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Events
11
2.Secondary Outcome
Title Number of Subjects Who Met Criteria to Restart Antiretroviral Therapy Before Week 48
Hide Description The secondary endpoint was defined as number of subjects who experienced plasma viremia following ATI and met criteria to restart cART before week 48 [a confirmed >30% decline in baseline CD4+ T Cell count or an absolute CD4+ T Cell count in the setting of detectable HIV viremia (>40 copies/mL); a sustained (>4weeks) HIV RNA level of > 1000 copies/mL, or any HIV related symptoms or pregnancy.]
Time Frame From Week 22 until up to 48 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses includes all subjects who entered into the analytical treatment interruption at Week 22
Arm/Group Title Vedolizumab in HIV-infected Adults on cART
Hide Arm/Group Description:
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
13
  72.2%
Time Frame up to 72 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vedolizumab in HIV-infected Adults on cART
Hide Arm/Group Description HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
All-Cause Mortality
Vedolizumab in HIV-infected Adults on cART
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Serious Adverse Events
Vedolizumab in HIV-infected Adults on cART
Affected / at Risk (%)
Total   1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Neck pain   1/20 (5.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vedolizumab in HIV-infected Adults on cART
Affected / at Risk (%)
Total   19/20 (95.00%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia   1/20 (5.00%) 
Cardiac disorders   
Palpitations   1/20 (5.00%) 
Tachycardia   1/20 (5.00%) 
Gastrointestinal disorders   
Abdominal pain   1/20 (5.00%) 
Constipation   1/20 (5.00%) 
Diarrhoea   2/20 (10.00%) 
Hiatus hernia   1/20 (5.00%) 
Nausea   2/20 (10.00%) 
General disorders   
Fatigue   4/20 (20.00%) 
Influenza like illness   1/20 (5.00%) 
Pain   1/20 (5.00%) 
Pyrexia   1/20 (5.00%) 
Immune system disorders   
Hypersensitivity   1/20 (5.00%) 
Infections and infestations   
Acute sinusitis   1/20 (5.00%) 
Bronchitis   3/20 (15.00%) 
Campylobacter gastroenteritis   1/20 (5.00%) 
Campylobacter infection   1/20 (5.00%) 
Epididymitis   1/20 (5.00%) 
Furuncle   1/20 (5.00%) 
Gastroenteritis   3/20 (15.00%) 
Giardiasis   1/20 (5.00%) 
Gonorrhoea   1/20 (5.00%) 
Herpes simplex   1/20 (5.00%) 
Influenza   1/20 (5.00%) 
Nasopharyngitis   8/20 (40.00%) 
Otitis media acute   1/20 (5.00%) 
Pharyngitis   1/20 (5.00%) 
Upper respiratory tract infection   5/20 (25.00%) 
Urinary tract infection   1/20 (5.00%) 
Viral infection   2/20 (10.00%) 
Injury, poisoning and procedural complications   
Contusion   1/20 (5.00%) 
Ligament sprain   1/20 (5.00%) 
Investigations   
Alanine aminotransferase increased   4/20 (20.00%) 
Aspartate aminotransferase increased   3/20 (15.00%) 
Blood bicarbonate decreased   8/20 (40.00%) 
Blood creatine phosphokinase increased   2/20 (10.00%) 
Blood creatinine increased   5/20 (25.00%) 
Blood glucose decreased   1/20 (5.00%) 
Blood glucose increased   9/20 (45.00%) 
Blood magnesium decreased   1/20 (5.00%) 
Blood phosphorus decreased   7/20 (35.00%) 
Blood potassium decreased   3/20 (15.00%) 
Blood sodium decreased   2/20 (10.00%) 
Blood sodium increased   2/20 (10.00%) 
Eosinophil count increased   1/20 (5.00%) 
Neutrophil count decreased   1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Back pain   1/20 (5.00%) 
Costochondritis   1/20 (5.00%) 
Musculoskeletal pain   2/20 (10.00%) 
Myalgia   1/20 (5.00%) 
Nervous system disorders   
Headache   3/20 (15.00%) 
Renal and urinary disorders   
Dysuria   2/20 (10.00%) 
Nephrolithiasis   1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough   1/20 (5.00%) 
Oropharyngeal pain   1/20 (5.00%) 
Pleurisy   1/20 (5.00%) 
Rhinorrhoea   1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Papule   1/20 (5.00%) 
Pruritus   1/20 (5.00%) 
Rash   1/20 (5.00%) 
Urticaria   1/20 (5.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael C. Sneller
Organization: NIAID
Phone: 301-496-0491
EMail: MSNELLER@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT02788175    
Other Study ID Numbers: 160118
16-I-0118
First Submitted: May 28, 2016
First Posted: June 2, 2016
Results First Submitted: November 25, 2019
Results First Posted: December 16, 2019
Last Update Posted: February 24, 2020