Trial Outcomes & Findings for Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption (NCT NCT02788175)
NCT ID: NCT02788175
Last Updated: 2020-02-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
From the start of the initial infusion until up to 72 weeks.
Results posted on
2020-02-24
Participant Flow
Participant milestones
| Measure |
Vedolizumab in HIV-infected Adults on cART
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
Received Study Agent
|
20
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Vedolizumab in HIV-infected Adults on cART
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
|
|---|---|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Ineligible prior to study agent
|
6
|
Baseline Characteristics
Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption
Baseline characteristics by cohort
| Measure |
Vedolizumab in HIV-infected Adults on cART
n=26 Participants
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of the initial infusion until up to 72 weeks.Population: The analyses included all subjects who received at least one infusion of vedolizumab
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.
Outcome measures
| Measure |
Vedolizumab in HIV-infected Adults on cART
n=20 Participants
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
|
|---|---|
|
Number of Grade 2 or Higher Related Adverse Events
|
11 Events
|
SECONDARY outcome
Timeframe: From Week 22 until up to 48 weeks.Population: The analyses includes all subjects who entered into the analytical treatment interruption at Week 22
The secondary endpoint was defined as number of subjects who experienced plasma viremia following ATI and met criteria to restart cART before week 48 \[a confirmed \>30% decline in baseline CD4+ T Cell count or an absolute CD4+ T Cell count in the setting of detectable HIV viremia (\>40 copies/mL); a sustained (\>4weeks) HIV RNA level of \> 1000 copies/mL, or any HIV related symptoms or pregnancy.\]
Outcome measures
| Measure |
Vedolizumab in HIV-infected Adults on cART
n=18 Participants
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
|
|---|---|
|
Number of Subjects Who Met Criteria to Restart Antiretroviral Therapy Before Week 48
|
13 Participants
|
Adverse Events
Vedolizumab in HIV-infected Adults on cART
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vedolizumab in HIV-infected Adults on cART
n=20 participants at risk
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • up to 72 weeks
|
Other adverse events
| Measure |
Vedolizumab in HIV-infected Adults on cART
n=20 participants at risk
HIV-infected Adults (age 18 - 65) on CART with suppressed viremia
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.0%
1/20 • up to 72 weeks
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • up to 72 weeks
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • up to 72 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • up to 72 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • up to 72 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
5.0%
1/20 • up to 72 weeks
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • up to 72 weeks
|
|
General disorders
Fatigue
|
20.0%
4/20 • up to 72 weeks
|
|
General disorders
Influenza like illness
|
5.0%
1/20 • up to 72 weeks
|
|
General disorders
Pain
|
5.0%
1/20 • up to 72 weeks
|
|
General disorders
Pyrexia
|
5.0%
1/20 • up to 72 weeks
|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Acute sinusitis
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Bronchitis
|
15.0%
3/20 • up to 72 weeks
|
|
Infections and infestations
Campylobacter gastroenteritis
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Campylobacter infection
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Epididymitis
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Furuncle
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Gastroenteritis
|
15.0%
3/20 • up to 72 weeks
|
|
Infections and infestations
Giardiasis
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Gonorrhoea
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Herpes simplex
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Nasopharyngitis
|
40.0%
8/20 • up to 72 weeks
|
|
Infections and infestations
Otitis media acute
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
5/20 • up to 72 weeks
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • up to 72 weeks
|
|
Infections and infestations
Viral infection
|
10.0%
2/20 • up to 72 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20 • up to 72 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.0%
1/20 • up to 72 weeks
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
4/20 • up to 72 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
3/20 • up to 72 weeks
|
|
Investigations
Blood bicarbonate decreased
|
40.0%
8/20 • up to 72 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
2/20 • up to 72 weeks
|
|
Investigations
Blood creatinine increased
|
25.0%
5/20 • up to 72 weeks
|
|
Investigations
Blood glucose decreased
|
5.0%
1/20 • up to 72 weeks
|
|
Investigations
Blood glucose increased
|
45.0%
9/20 • up to 72 weeks
|
|
Investigations
Blood magnesium decreased
|
5.0%
1/20 • up to 72 weeks
|
|
Investigations
Blood phosphorus decreased
|
35.0%
7/20 • up to 72 weeks
|
|
Investigations
Blood potassium decreased
|
15.0%
3/20 • up to 72 weeks
|
|
Investigations
Blood sodium decreased
|
10.0%
2/20 • up to 72 weeks
|
|
Investigations
Blood sodium increased
|
10.0%
2/20 • up to 72 weeks
|
|
Investigations
Eosinophil count increased
|
5.0%
1/20 • up to 72 weeks
|
|
Investigations
Neutrophil count decreased
|
5.0%
1/20 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
5.0%
1/20 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
2/20 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • up to 72 weeks
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • up to 72 weeks
|
|
Renal and urinary disorders
Dysuria
|
10.0%
2/20 • up to 72 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.0%
1/20 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
5.0%
1/20 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
5.0%
1/20 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • up to 72 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place