Clinical trials: Monitoring, Immunologic
Human Immunodeficiency Virus
Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
The two original objectives were to determine in HIV-infected children initiating antiretroviral therapy (ART): 1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of disease progression or death as…
- Trial name
- ARROW (NCT02028676)
- Testing
- Clinically Driven Monitoring (CDM), Laboratory plus Clinical Monitoring (LCM), Arm A: ABC+3TC+NNRTI
- Where
- 4 sites in Uganda, Zimbabwe
- Volunteers
- 1,206 people
- Sponsor
- Medical Research Council
Poliomyelitis
Serological Survey on Monitoring the Positive Rate After Vaccination of Inactivated Polio Vaccine
The Purpose of this study is to assess the seroconversion using inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) sequential schedule in pilot areas where IPV was phased introduced into national immunization…
- Trial name
- IPV (NCT02643446)
- Testing
- IPV, OPV
- Where
- 5 sites in China
- Volunteers
- 809 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention, China
HIV/AIDS
The Intensified Treatment Monitoring Strategy to Prevent Accumulation of Drug Resistance (ITREMA) Trial
The ITREMA trial is an open-label randomized controlled trial (RCT) in which HIV-1 infected patients initiating first-line ART and already on first-line ART will be enrolled.
- Trial name
- ITREMA (NCT03357588)
- Testing
- Intensified monitoring, Standard of care monitoring
- Where
- South Africa
- Volunteers
- 501 people
- Sponsor
- UMC Utrecht
Hiv
'Activity Pacing' in PLWH With Fatigue Symptoms.
Physical activity helps to improve health and prevent chronic diseases. However, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (CFCs), such as…
- Trial name
- ActiPacMAN (NCT05194059)
- Testing
- Home-based physical activity
- Where
- Italy
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Scientific Institute San Raffaele
HIV/AIDS, Adherence
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).
- Trial name
- NCT01957865
- Testing
- Fixed SMS, real-time monitoring, Triggered SMS, real-time monitoring
- Where
- Uganda
- Volunteers
- 63 people
- Sponsor
- Massachusetts General Hospital
Healthy
A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants
The purpose of this study is to characterize the immune response in vivo using approved vaccines and antigen challenges, as well as a skin wounding challenge to stimulate the immune system.
- Trial name
- NCT03953196
- Testing
- Imvanex, Shingrix, LPS
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Periprosthetic Hip Infection
Analysis of Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection: a Microdialysis Study
This study aims to use the technique of microdialysis to analyse the intraarticular space of the hip joint after removal of a periprosthetic joint infection affected endoprosthesis and implantation of an antibiotic-containing…
- Trial name
- PJI_H_MD (NCT07299591)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University Hospital, Bonn
HIV
Male Engagement in PMTCT Services
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services.
- Trial name
- NCT01903889
- Testing
- clinic based intervention, clinic and community based intervention
- Where
- 7 sites in Uganda
- Volunteers
- 3,806 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV Infection, Pregnancy
Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women
The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy and postpartum, and to record adherence barriers and facilitators.
- Trial name
- NCT01621347
- Where
- Switzerland
- Volunteers
- 26 people
- Sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Bladder Carcinoma
First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma
This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3 severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab) in first-line treatment for locally advanced or…
- Trial name
- GCISAVE (NCT03324282)
- Testing
- Avelumab, GC
- Where
- 13 sites in France
- Volunteers
- 65 people
- Sponsor
- University Hospital, Bordeaux
HIV Infections
Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany
TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany.
- Trial name
- TRIUMPH (NCT02342769)
- Testing
- Dolutegravir/Abacavir/Lamivudin
- Where
- 29 sites in Germany
- Volunteers
- 403 people
- Sponsor
- ViiV Healthcare
Kidney Transplant Immunosuppression
The Role of ImmuKnow® in the Management of Immunosuppressants in the Renal Transplant Patient
The purpose of this study is to demonstrate whether there are any outcome benefits of a serial ImmuKnow assays in the management of de novo renal transplant recipients.
- Trial name
- NCT01424345
- Testing
- adjustment of immunosuppressant dosages, adjustment of the dosages of immunosuppressants
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- CAMC Health System
Periprosthetic Knee Infection
Analysis of Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Knee Infection: a Microdialysis Study
This study aims to use the technique of microdialysis to analyse the intraarticular space of the knee joint after removal of a periprosthetic joint infection affected endoprosthesis and implantation of an antibiotic-containing…
- Trial name
- PJI_K_MD (NCT07299565)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University Hospital, Bonn
Maternal and Child Health
Evaluation of the Effectiveness of a Quality Improvement Intervention
This rigorous evaluation demonstrated that implementation of a time-limited quality improvement strategy effectively improved coverage of some components of an integrated maternal and child health service in a complex health…
- Trial name
- NCT04278612
- Testing
- Quality improvement intervention to strengthen health service provision
- Volunteers
- 1,438 people
- Sponsor
- University of KwaZulu
Diabetes Mellitus, Pulmonary Tuberculosis
Pulmonary Tuberculosis Patients With Diabetes Mellitus
The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis- diabetes patients.
- Trial name
- TANDEM (NCT02106039)
- Testing
- intensive monitoring
- Where
- 3 sites in Indonesia, Peru and 1 more
- Volunteers
- 350 people
- Sponsor
- Universitas Padjadjaran
Acquired Immunodeficiency Syndrome, HIV Infection
Clinic-based ART Diagnostic Evaluation
The study is funded through the Office of the Global AIDS Coordinator (OGAC #KE-07-0044). The purpose of this study is two-fold.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infection, RNA Virus Infections, Virus Diseases
- Trial name
- CLADE (NCT01791556)
- Testing
- HIV-1 viral load testing
- Where
- Kenya
- Volunteers
- 820 people
- Sponsor
- Walter Reed Army Institute of Research (WRAIR)
Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum
Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS)
This Phase 2 study tests whether adding two immune therapies - nogapendekin alfa-inbakicept (NAI) and off-the-shelf iNKT cell infusions - to standard care can safely help critically ill adults with severe community-acquired…
- Conditions
- Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum, Sepsis, Lymphopenia / Immunoparalysis in Critically Ill Adults
- Trial name
- NCT07492888
- Testing
- Nogapendekin Alfa-Inbakicept (NAI), Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)
- Sponsor
- ImmunityBio, Inc.
HIV Infection
The Pharmacology/Aging Clinic
The treatment of HIV and the tests performed for HIV care have changed over the last 20 years. However, improvement of management of HIV-infected subjects is still warranted, especially as the HIV-infected population is aging.
- Trial name
- SSAT041 (NCT01286623)
- Where
- United Kingdom
- Volunteers
- 75 people
- Sponsor
- St Stephens Aids Trust
HIV-1-infection, Antiretroviral Therapy
HIV Transmission in the Era of Scaling up Antiretroviral Therapy in Ethiopia
The goal of this observational study is to understand patterns of HIV transmission in a high-prevalence area in Ethiopia, and to compare viral genetic information in people with HIV who are newly diagnosed and have not been…
- Trial name
- THESA (NCT05652400)
- Testing
- Exposure to antiretroviral therapy
- Where
- Ethiopia
- Volunteers
- 2,200 people
- Sponsor
- Lund University
HIV, Human Immunodeficiency Virus
Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study
The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.
- Conditions
- HIV, Human Immunodeficiency Virus, ART
- Trial name
- NCT06176859
- Testing
- HIV PrEP Delivery
- Where
- South Africa
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital