Clinical trials: Immunology
Hepatitis B
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.
- Trial name
- INSIGHT (NCT04585789)
- Testing
- JNJ-73763989, JNJ-56136379, Entecavir (ETV)
- Where
- 10 sites in United States, Belgium and 7 more
- Volunteers
- 24 people
- Sponsor
- Janssen Research & Development, LLC
Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
- Conditions
- Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis, Inherited Bone Marrow Failure Syndrome, Hemoglobinopathies
- Trial name
- NCT02231710
- Testing
- BPX-501 and Rimiducid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals
HIV/AIDS, Adherence, Medication
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine…
- Conditions
- HIV/AIDS, Adherence, Medication, Drug Use
- Trial name
- NCT03584282
- Testing
- Text Messaging, Peer Navigation
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1)…
- Trial name
- NCT00105079
- Testing
- saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 44 sites in United States, Canada and 3 more
- Volunteers
- 337 people
- Sponsor
- Hoffmann-La Roche
Eosinophilic Esophagitis
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538.
- Trial name
- NCT04991935
- Testing
- CC-93538
- Where
- 167 sites in United States, Argentina and 13 more
- Volunteers
- 367 people
- Sponsor
- Celgene
HIV Infections
Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1
This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care…
- Trial name
- JUNGLE (NCT03518060)
- Testing
- JULUCA
- Where
- 23 sites in Germany
- Volunteers
- 209 people
- Sponsor
- ViiV Healthcare
HIV Infections
Qualitative Assessment of Implementing Routine Rapid HIV Testing
Qualitative assessment of implementing routine HIV rapid testing in primary care clinics within VA
- Trial name
- NCT00680862
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Hereditary Angioedema (HAE)
Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
The purpose of this study is to determine if an investigational treatment is safe and well tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.
- Trial name
- NCT02865720
- Testing
- CINRYZE 500 U, CINRYZE 1000 U
- Where
- 10 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Shire
Hereditary Angioedema
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE
The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3.
- Trial name
- NCT00914966
- Testing
- C1 inhibitor (human) [C1 INH]
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of…
- Trial name
- NCT02052141
- Testing
- CINRYZE 500, CINRYZE 1000
- Where
- 8 sites in United States, Germany and 3 more
- Volunteers
- 12 people
- Sponsor
- Shire
HIV/AIDS, Hypertension
Systems Analysis and Improvement Approach for the Hypertension Care Cascade
As undiagnosed and untreated hypertension is one of the largest drivers of cardiovascular disease in sub-Saharan Africa approaches are needed to optimize the hypertension care cascade.
- Trial name
- SAIA-HTN (NCT04088656)
- Testing
- Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization
- Where
- 16 sites in Mozambique
- Volunteers
- 305 people
- Sponsor
- University of Washington
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01854775
- Testing
- E/C/F/TAF, E/C/F/TAF (Low Dose)
- Where
- 16 sites in United States, South Africa and 3 more
- Volunteers
- 129 people
- Sponsor
- Gilead Sciences
HIV Infections
Mechanisms of Lipodystrophy in HIV-Infected Pateints
The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the…
- Trial name
- NCT00457665
- Testing
- Nelfinavir, Efavirenz
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Texas Southwestern Medical Center
HIV Infections, Hepatic Steatosis
Pioglitazone to Treat Fatty Liver in People With HIV Infection
This study will determine whether pioglitazone (Actos, a drug approved to treat diabetes, can benefit HIV-infected people with fatty liver.
- Conditions
- HIV Infections, Hepatic Steatosis, Insulin Resistance
- Trial name
- NCT00441272
- Testing
- Pioglitazone
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immunodeficiency
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the…
- Trial name
- NCT04566692
- Testing
- IGSC 20%
- Where
- 12 sites in United States
- Volunteers
- 33 people
- Sponsor
- Grifols Therapeutics LLC
HIV Infections
Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Participants (VICTOR-E1) (MK-7690-020/P03672)
Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers.
- Trial name
- VICTOR-E1 (NCT00243230)
- Testing
- Vicriviroc 30 mg, Vicriviroc 20 mg, Background ART Regimen
- Volunteers
- 116 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to…
- Trial name
- NCT02097108
- Testing
- Raltegravir
- Where
- 3 sites in Austria
- Volunteers
- 11 people
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
HIV Infections
The Safety and Immunogenicity of a Potential HIV Vaccine
The potential HIV vaccine has two components: a protein immunogen based on the coat protein of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen.
- Trial name
- NCT01966900
- Testing
- CN54gp140 mixed with GLA-AF
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Imperial College London
HIV, HIV Infections
Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz…
- Trial name
- NCT01095796
- Testing
- Stribild, Atripla
- Where
- 102 sites in United States, Puerto Rico
- Volunteers
- 707 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each…
- Trial name
- NCT02582983
- Testing
- Enfuvirtide
- Where
- 5 sites in Thailand
- Volunteers
- 23 people
- Sponsor
- Hoffmann-La Roche
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