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Displaying 1 - 19 of 19

Open Actively Recruiting

Adalimumab vs. Conventional Immunosuppression for Uveitis Trial

Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-TNF-α monoclonal antibody, now US FDA-approved for uveitis treatment, may be a superior corticosteroid-sparing agent than conventional immunosuppressive drugs. The ADVISE Trial is multicenter randomized, parallel-treatment, comparative effectiveness trial comparing adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in the treatment of non-infectious, intermediate, posterior, and panuveitides.

Phase: Phase IV
Primary Purpose: Treatment
Gender: All
Age Group: All
Contact: Gary Holland
Open Actively Recruiting

IMPACT OF HIV ON GUT-ASSOCIATED LYMPHOID TISSUE (GALT)

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Contact: Irma Franco-Gonzalez
Open Actively Recruiting

Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)

Participants will be randomized in a 2:1 ratio to receive either two injections of CMV-MVA Triplex® or placebo administered at study Entry/Day 0 and week 4.

Vaccine Group: 60 participants will receive CMV-MVA Triplex® containing 5 x 10^8 plaque-forming unit (pfu) ±0.5 x 10^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections. Placebo Group: 30 participants will receive a volume of placebo (7.5% Lactose in phosphate-buffered saline [PBS]) that matches the volume of the active vaccine injection by IM deltoid injections.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Contact: Irma Franco-Gonzalez
Open Actively Recruiting

Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption

The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Contact: Irma Franco-Gonzalez
Open Actively Recruiting

Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide

The primary purpose of this study is to see if people with HIV who had a significant weight gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of weight gain or lose weight within about 1 year if they switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication). The study will also try to see if participants changing from TAF/FTC (or TAF/3TC) to TDF/FTC (or TDF/3TC) will experience less additional weight gain or a reduction in overall body weight at 48 weeks compared to persons continued on an INSTI + TAF/FTC (or TAF/3TC) combination. INSTINs assessed in A5391 include bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL). Additionally, the study will see whether a change in ART can affect things like waist circumference, metabolic and cardiovascular health, fat and lean mass body composition, bone health, and maintenance of virologic suppression. Finally, the study will look at the safety and tolerability of DOR plus either TAF/FTC (or TAF/3TC) versus TDF/FTC (or TDF/3TC).

Phase: Phase IV
Primary Purpose: Treatment
Gender: All
Contact: Irma Franco-Gonzalez
Open Actively Recruiting

Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy

The purpose of this study is to evaluate the safety and immunotherapeutic activity of cemiplimab in participants with hepatitis B virus (HBV) on suppressive antiviral therapy.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Contact: Irma Franco-Gonzalez
Open Actively Recruiting

Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options

A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: All
Contact: William Swearingen
Open Actively Recruiting

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

The purpose of this study is to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination.

Phase: Phase III/IV
Primary Purpose: Prevention
Gender: All
Age Group: Adults
Contact: Lisa Mark
Open Actively Recruiting

Targeting Early Instigators of Vascular Inflammation to Prevent and/or Delay Vascular Aging in Chronic Treated HIV

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Nancy Lopez
Open Actively Recruiting

GUT: Immune Responses in the Gut During HIV Infection

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Jennifer Fulcher
Investigator: Otto O. Yang, MD
Open Actively Recruiting

ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19

This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.

The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Contact: Melissa Arevalo
Investigator: Otto O. Yang, MD
Open Actively Recruiting

Observational Cohort of Hospitalized Patients with COVID-19 at UCLA

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: All
Contact: Adreanne Rivera
Open Actively Recruiting

Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age

The purpose of this study is to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.

Phase: Phase I/II
Primary Purpose: Prevention
Gender: All
Age Group: Children
Contact: Michele Carter
Open Actively Recruiting

The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)

Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults with polymerase chain reaction (PCR)-Confirmed COVID-19.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Yesenia Calzada
Open Actively Recruiting

Compassionate Use of Leronlimab for Treatment of COVID-19 (SARS-CoV-2 Infection)

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Jenny Ahn
Investigator: Otto O. Yang, MD
Open Actively Recruiting

Sleep and Healthy Aging Research for Depression (SHARE-D) Study

Late-life depression is a significant public health concern, and effective interventions for prevention and treatment are needed. Insomnia and inflammation are modifiable targets for depression prevention, and this study is significant in using an experimental approach (i.e., inflammatory challenge) to probe acute inflammatory- and depression responses as a function of insomnia, which will inform identification of molecular targets for pharmacologic interventions, and improvement of insomnia treatments to prevent depression in older adults.

Project

Phase: Phase 1
Primary Purpose: Other
Gender: All
Age Group: Adults
Contact: Nina Sadeghi
Open Actively Recruiting

Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours

This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination with nivolumab in patients with metastatic or advanced epithelial tumours.

To characterize the safety and tolerability of NG-641 in combination with nivolumab in patients with metastatic or advanced epithelial tumours and to determine the recommended dose of NG-641 in combination with nivolumab for further development in patients with metastatic or advanced epithelial tumours

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer

The purpose of this phase 1 study is to investigate a new approach in the treatment of cancer, i.e. giving gene-modified immune cells combined with gene-modified stem cells intravenously to reprogram the immune system to attempt to fight the cancer. The goal is to teach the immune system to recognize and kill cancer cells that have the NY-ESO-1 protein with sustained killing activity. The gene-modified cells studied in this experimental protocol are the patient s own white blood cells and stem cells from blood that will be modified in the laboratory using genetic techniques to express the NY-ESO-1 TCR against cancer cells. The gene modification of the white blood cells is an attempt to direct the patient s own immune cells to kill cancer cells. Since these immune cells usually only last for a few months in the body before they die, stem cells will be gene-modified so that the patient s body can attempt to create new immune cells that will kill cancer cells. Gene modification of cells involves the transfer of foreign genetic material (DNA) into a cell, in this case the patient s immune system cells and stem cells. This process will endow the recipient immune cells and descendants of the stem cells with the ability to eliminate cancer cells that express the cancer specific protein, NY-ESO-1. The specific receptor against cancer cells that will be transferred to the immune cells and stem cells is called NY-ESO-1 T cell receptor (or TCR). In this study, the gene-modified immune cells will be given in combination with the gene-modified stem cells to all patients to test the safety, toxicity and tumor responses of administering this combination. The study procedures will start with the collection of stem cells by administering medicines to mobilize the stem cells from the bone marrow and deposit them in the peripheral blood and using a medical device called a blood cell separator. A cell separator will also be used to collect white blood cells. These cells will be grown in the laboratory and then genetically modified with a virus vector (lentivirus vector for stem cells and retrovirus vector for lymphocytes), extensively modified to make sure that it is not infectious. The lentivirus and retrovirus vectors will allow expression of NY-ESO-1 TCR on the surface of cancer cells which directs the immune system to recognize cancer as foreign and kill the cancer cells. The lentivirus will also carry a second gene, Herpes Simplex Virus 1 (HSV1) sr39 thymidine kinase (TK) reporter gene, which will allow the progeny gene modified immune cells to be visualized when a PET scan is performed. The TCR gene modified cells will be tested to make sure that they are not contaminated with bacteria and other organisms, and that they express the appropriate TCR. The stem cells will be frozen prior to administration and the lymphocytes will be administered fr

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: All
Contact: Elizabeth Seja
Open Actively Recruiting

A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies

ATRC-101-A01 is a Phase 1b, open-label dose escalation trial of ATRC-101, an engineered fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally occurring human antibody. The safety, tolerability, PK, and biological activity of ATRC-101 will be characterized when administered every two weeks (Q2W) or every 3 weeks (Q3W) as a monotherapy or in combination with other anticancer agents.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Rosleen Mala