Here is the design of a clinical trial:

Official Title: Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection

Included conditions:
- HIV-infection/AIDS

Study Armgroups:
- {'label': 'Group A-150mg dose of vedolizumab per infusion followed by ATI - Low Dose', 'type': 'EXPERIMENTAL', 'description': '\\* Please note that the previous low dose arm was 75mg of vedolizumab per infusion, but no participant was ever given this dose. The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 150 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 doses as tolerated. ATI will begin between weeks 6 and 7, and infusions continued at weeks 8, 12, 16 and 20.', 'interventionNames': ['Biological: Vedolizumab (brand name Entyvio)']}
- {'label': 'Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose', 'type': 'EXPERIMENTAL', 'description': 'The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 300 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 (and up to 12) doses as tolerated. ATI will begin between week 10, and infusions continued at weeks 12, 16 and 20. Infusions may also be given at weeks 24, 28, 32, 36 and 40 depending on tolerance and pVL response.', 'interventionNames': ['Biological: Vedolizumab (brand name Entyvio)']}
- {'label': 'Group C-600mg dose of vedolizumab per infusion followed by ATI - High Dose', 'type': 'EXPERIMENTAL', 'description': 'The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 600 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 (and up to 12) doses as tolerated. ATI will begin between week 10, and infusions continued at weeks 12, 16 and 20. Infusions may also be given at weeks 24, 28, 32, 36 and 40 depending on tolerance and pVL response.', 'interventionNames': ['Biological: Vedolizumab (brand name Entyvio)']}

Interventions:
- {'type': 'BIOLOGICAL', 'name': 'Vedolizumab (brand name Entyvio)', 'description': 'IV infusion', 'armGroupLabels': ['Group A-150mg dose of vedolizumab per infusion followed by ATI - Low Dose', 'Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose', 'Group C-600mg dose of vedolizumab per infusion followed by ATI - High Dose']}

Primary Outcomes:
- {'measure': 'Vedolizumab safety and tolerance', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, with their timing of onset and resolution.', 'timeFrame': '6 months vedolizumab treatments, serial assessments over 12 months'}

Please estimate the sample size based on the assumption: 
The trial does not explicitly state assumptions on significance level, power, or missing/dropout rate.
Study design, settings, sample size and recruitment strategy
        HAVARTI is a single-arm, dose-ranging pilot trial of serial vedolizumab infusions for the induction of HIV SVR in adults with chronic HIV infection on ART. Twelve consenting volunteers respecting all inclusion and exclusion criteria will be enrolled sequentially in groups of four to receive vedolizumab by infusion in 2-week to 4-week intervals for a total of seven doses. After three doses of vedolizumab, the participants will initiate the ATI portion of the study. During the ATI, participants will discontinue ART but continue with the four remaining scheduled vedolizumab treatments and monitoring of pVL and immunological markers. They will also have regular clinical assessment at each infusion visit. Participants will restart ART according to CD4 T-cell count and pVL threshold levels and trajectory, personal choice, or consensus judgement of the volunteer patient, treating physician and/or study investigators. Decisions to continue ATI or restart ART in the presence of CD4, pVL and clinical indicators will be reviewed by an independent expert medical monitor and reported to the Data Safety Monitoring Board (DSMB) in a timely manner.
        Study participants will be recruited from The Ottawa Hospital (TOH) HIV clinic and referring primary care facilities. Informed consent will be obtained from those patients who are documented to be eligible for the trial after pre-screening. Table 1 shows the safety laboratory tests and concomitant medication surveys to be done during screening. Individuals who wish to discuss enrolment in the trial with family, partner, friends or their treating physician may take the time and choose to enrol at a subsequent clinic visit. Once enrolled, the participant will be followed concomitantly by the principal investigator and study staff at TOH for the duration of the trial.
        
          Table 1
          
            Study visit schedule
          
          
            
              
                Study activity/visit*
                Screening
                Baseline
                Week 0
                Week 2
                Week 5
                Weeks 6 to 7â 
                Week 8
                Week 12
                Week 16
                Week 20
                Week 24
                Weeks 28, 32, 36, 40, 44, 48
                Week 52
              
            
            
              
                Informed consent
                X
                X
                X
                
                â
                â
                â
                â
                â
                â
                â
                â
                â
              
              
                Eligibility confirmation
                X
                X
                
                â
                â
                â
                â
                â
                â
                â
                â
                â
                â
              
              
                Concomitant medicines
                X
                X
                X
                X
                X
                
                X
                X
                X
                X
                X
                X
                
              
              
                Pregnancy test if applicableâ¡
                X
                
                â
                â
                â
                â
                â
                â
                â
                â
                â
                â
                â
              
              
                Safety laboratories (CBC, WBC, serum chemistryÂ§, ESR)
                XÂ¶
                X
                X
                X
                
                â
                X
                X
                X
                X
                X
                X
                X
              
              
                Serum (10âmL)
                
                X
                X
                X
                X
                
                X
                X
                X
                X
                X
                X
                
              
              
                Plasma (10âmL)
                
                X
                X
                X
                X
                X
                X
                X
                X
                X
                X
                X
                
              
              
                PBMCs from whole blood**
                
                X
                
                â
                X
                
                â
                â
                â
                â
                X
                
                â
              
              
                Plasma viral load
                X
                X
                
                â
                â
                â
                X
                X
                X
                X
                X
                X
                X
              
              
                CD4
                X
                X
                
                â
                â
                â
                X
                X
                X
                X
                X
                X
                X
              
              
                Vedolizumab intravenous infusion
                
                â
                X
                X
                X
                
                X
                X
                X
                X
                
                â
                â
              
              
                History and physical
                Xâ â 
                X
                X
                X
                X
                
                X
                X
                X
                X
                X
                X
                X
              
              
                Optional CSF specimen
                
                â
                â
                â
                â
                â
                â
                â
                â
                â
                X
                
                â
              
              
                Optional rectal mucosal biopsy
                
                X
                
                â
                â
                â
                â
                â
                â
                â
                X
                
                X
              
              
                Optional stool sample
                
                X
                
                â
                â
                â
                â
                â
                â
                â
                X
                
                X
              
              
                AE assessment
                
                X
                X
                X
                X
                X
                X
                X
                X
                X
                X
                X
                X
              
            
          
          
            
              *Study visits may occur Â±1âweek from the time points outlined in the table.
            
            
              â ATI (analytical treatment interruption) will occur at weeks 6â7.
            
            
              â¡Pregnancy testing with urine dip for Î²-human chorionic gonadotropin may be repeated at any study visit where it is felt to be indicated by the patient or the study investigator.
            
            
              Â§Serum chemistry includes albumin (total), alanine transaminase, alkaline phosphatase, amylase, aspartate transaminase, bilirubin (total), blood glucose (random), blood urea nitrogen, calcium, chloride, C reactive protein, creatinine, gamma-glutamyl transferase, potassium, protein (total) and sodium.
            
            
              Â¶Safety laboratory items have been measured within 1âyear of the screening visit; these results may be used for screening purposes.
            
            
              **50â100âmL whole blood for separation and cryopreservation of PBMCs.
            
            
              â â The history taken at screening will be more thorough than subsequent visits (ie, height only taken once). Confirmation of HIV+ by western blot or other standard test required only at screening visit.
            
            
              AE, adverse event; CBC, complete blood cell count; CSF, cerebrospinal fluid; ESR, erythrocyte sedimentation rate; PBMC, peripheral blood mononuclear cell; WBC, white blood cell count.