Clinical trials: Treatment Interruption
HIV Infection
Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC)
PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with…
- Trial name
- PHPC-02 (NCT00918840)
- Testing
- DermaVir, HAART
- Where
- Italy
- Volunteers
- 16 people
- Sponsor
- Genetic Immunity
Relapsing Remitting Multiple Sclerosis
Treatment Interruption of Natalizumab
This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab.
- Trial name
- RESTORE (NCT01071083)
- Testing
- natalizumab, interferon beta 1-a, methylprednisolone
- Where
- 33 sites in United States, Germany and 1 more
- Volunteers
- 175 people
- Sponsor
- Biogen
Brain Tumor
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric…
- Trial name
- NCT05615623
- Testing
- Exablate, Doxorubicin
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- InSightec
Type 2 Diabetes Mellitus
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions…
- Trial name
- NCT00516048
- Testing
- exenatide
- Where
- 13 sites in Australia, Canada and 3 more
- Volunteers
- 58 people
- Sponsor
- AstraZeneca
Primary Myelofibrosis
A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)
The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after treatment interruption due to loss of response and/or adverse events.
- Trial name
- NCT02091752
- Testing
- Ruxolitinib
- Where
- 3 sites in Germany, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Novartis Pharmaceuticals
HIV-1 Infection
A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART
GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases.
- Trial name
- NCT01378156
- Testing
- JS7 plasmid DNA and MVA62B vaccine
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- GeoVax, Inc.
HIV Seropositivity, HIV Infection
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in…
- Trial name
- NCT00035893
- Testing
- poly I-poly C12U
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- AIM ImmunoTech Inc.
Glioblastoma
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption for Treatment of Glioma
The purpose of this study is to evaluate the safety of blood-brain barrier (BBB) disruption in adult patients with a first presentation of a glioblastoma (GBM) following a maximal safe surgical resection and standard…
- Trial name
- NCT03616860
- Testing
- Focused Ultrasound (FUS) BBB Disruption
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- InSightec
Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Investigation of Sacroiliac Fusion Treatment (INSITE)
The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint)undergo either SI…
- Trial name
- INSITE (NCT01681004)
- Testing
- iFuse Implant System, Non-surgical management
- Where
- 19 sites in United States
- Volunteers
- 159 people
- Sponsor
- SI-BONE, Inc.
HIV Infections
Phase II Study of AGS-004 as an Immunotherapeutic in Antiretroviral Therapy (ART)-Treated Subjects Infected With HIV
The purpose of this study is to examine the ability of AGS-004 to control HIV-1 replication and to determine if HIV-1 immunotherapy made with dendritic cells is safe and well tolerated, to determine if immunotherapy increases the…
- Trial name
- NCT00672191
- Testing
- AGS-004
- Where
- 12 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- Argos Therapeutics
Breast Neoplasm Female
RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant…
- Trial name
- BREVITY (NCT03524430)
- Testing
- Core needle biopsy
- Where
- 7 sites in United States, Canada and 5 more
- Volunteers
- 801 people
- Sponsor
- Rna Diagnostics Inc.
Degenerative Sacroilitis, Sacroiliac Joint Disruption
LOIS: Long-Term Follow-Up in INSITE/SIFI
The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).
- Trial name
- LOIS (NCT02270203)
- Testing
- Pelvic CT at 5 years post-op
- Where
- 12 sites in United States
- Volunteers
- 103 people
- Sponsor
- SI-BONE, Inc.
Alzheimer Disease
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
- Trial name
- NCT03671889
- Testing
- Blood Brain Barrier (BBB) Disruption
- Where
- 10 sites in United States
- Volunteers
- 50 people
- Sponsor
- InSightec
Human Immunodeficiency Virus (HIV), HIV Infection
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in…
- Conditions
- Human Immunodeficiency Virus (HIV), HIV Infection, HIV-1
- Trial name
- NCT04223804
- Testing
- ABBV-181
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 41 people
- Sponsor
- AbbVie
Glioma, Glioblastoma
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption
The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.
- Trial name
- NCT03551249
- Testing
- Focused ultrasound (FUS)
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- InSightec
HIV Infection
Safety and Efficacy Study of AGS-004 During Analytical Treatment Interruption
The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune therapy, for HIV-infected individuals.
- Trial name
- NCT01069809
- Testing
- AGS-004
- Where
- 9 sites in United States, Canada
- Volunteers
- 53 people
- Sponsor
- Argos Therapeutics
HIV
An Antiretroviral Treatment Interruption (ATI) Study to Evaluate the Impact of Genetically Modified Autologous Cells (AGT103-T) to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy
To test the hypothesis that AGT103-T cells therapy will allow HIV positive individual to reduce, modify or eliminate antiretroviral therapy.
- Trial name
- NCT05540964
- Testing
- Antiretroviral Therapy Interruption(ATI)
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- American Gene Technologies International Inc.
Hidradenitis Suppurativa
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens…
- Trial name
- NCT04179175
- Testing
- secukinumab
- Where
- 191 sites in United States, Argentina and 36 more
- Volunteers
- 702 people
- Sponsor
- Novartis Pharmaceuticals
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.