Search Results | Research Studies | School of Medicine


Giving Standardized Estradiol Therapy in Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study A5403 is a phase IIb, 48-week, open-label, non-randomized, 3-group trial, of 90 adult (=18 years) transgender women and other individuals identifying as female or transfeminine but with male sex assigned at birth (TW) living with HIV on suppressive antiretroviral therapy (ART) and not curr...
Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
Evaluation of the feasibility, acceptability, and effectiveness of TelePrEP for at-risk youth in Colorado Childrens Hospital Colorado This study aims to assess whether PrEP delivery via a telehealth (termed TelePrEP throughout) approach supports persistence and retention on oral PrEP for young people and identify barriers and facilitators of TelePrEP for youth. The proposed research will address the critical need to iden...
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission Outpatient CTRC, University of Colorado Hospital Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broad...
The High-Intensity Exercise to Attenuate Limitations and Train Habits (HEALTH) in Older Adults with HIV Brain Imaging Center (BIC) - Scan Read, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
NEONATAL ENTEROVIRUS AND HUMAN PARECHOVIRUS VIRAL SEPSIS: NATURAL HISTORY AND PREDICTORS OF MORBIDITY AND MORTALITY Childrens Hospital Colorado
Influenza-Specific Immunity and Responses to Inactivated Influenza Vaccine in Infants: Effect of Maternal Vaccination During Pregnancy Childrens Hospital Colorado, University of Colorado Hospital This study aims to learn more about how babies' immune systems react to the influenza vaccine and if there is any difference between babies whose mothers receive the influenza vaccine, or not, before the baby is born. Study visits will take place during prenatal care and delivery as well a...
Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants Childrens Hospital Colorado, Highlands Ranch Hospital, University of Colorado Hospital Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado....
A5418 A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease Study of Tecovirimat for Human Monkeypox Virus (STOMP) Childrens Hospital Colorado Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease. The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and br...
PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) Childrens Hospital Colorado, University of Colorado Hospital The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ...
Gut microbiome effects on intestinal barrier function in metabolic syndrome in HIV positive men who have sex with men Outpatient CTRC, University of Colorado Hospital
A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease Adult Infectious Disease Clinical Trials Center, Outpatient CTRC, University of Colorado Hospital Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants ...
A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections - Appendix E-2: Immune Modulation Strategy Trial Outpatient CTRC, University of Colorado Hospital
A Phase 2, Randomized, Double-blind, Placebo-controlled, 2-part Study To Evaluate EDP-938 Regimens In Subjects Aged 28 Days To 36 Months Infected With Respiratory Syncytial Virus (RSV) Childrens Hospital Colorado Study subjects will take an oral medication/placebo. Study activities include blood draws, nasal swabs, ECGs, and e-diary entries...
Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL) Childrens Hospital Colorado Enrolling now through August 31st. This study is testing a nasal spray vaccine for RSV. Participants will need to attend 3-5 study visits, 2-4 blood draws, and e-diary entries to monitor for RSV-like illness. Participants will also need to return for any illness visits. ...

Giving Standardized Estradiol Therapy in Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study

A5403 is a phase IIb, 48-week, open-label, non-randomized, 3-group trial, of 90 adult (=18 years) transgender women and other individuals identifying as female or transfeminine but with male sex assigned at birth (TW) living with HIV on suppressive antiretroviral therapy (ART) and not curr...

Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Evaluation of the feasibility, acceptability, and effectiveness of TelePrEP for at-risk youth in Colorado

Childrens Hospital Colorado

This study aims to assess whether PrEP delivery via a telehealth (termed TelePrEP throughout) approach supports persistence and retention on oral PrEP for young people and identify barriers and facilitators of TelePrEP for youth. The proposed research will address the critical need to iden...

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission

Outpatient CTRC, University of Colorado Hospital

Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broad...

The High-Intensity Exercise to Attenuate Limitations and Train Habits (HEALTH) in Older Adults with HIV

Brain Imaging Center (BIC) - Scan Read, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

NEONATAL ENTEROVIRUS AND HUMAN PARECHOVIRUS VIRAL SEPSIS: NATURAL HISTORY AND PREDICTORS OF MORBIDITY AND MORTALITY

Childrens Hospital Colorado

Influenza-Specific Immunity and Responses to Inactivated Influenza Vaccine in Infants: Effect of Maternal Vaccination During Pregnancy

Childrens Hospital Colorado, University of Colorado Hospital

This study aims to learn more about how babies' immune systems react to the influenza vaccine and if there is any difference between babies whose mothers receive the influenza vaccine, or not, before the baby is born. Study visits will take place during prenatal care and delivery as well a...

Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants

Childrens Hospital Colorado, Highlands Ranch Hospital, University of Colorado Hospital

Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado....

A5418 A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease Study of Tecovirimat for Human Monkeypox Virus (STOMP)

Childrens Hospital Colorado

Phase 3, randomized, placebo-controlled, double-blind trial of tecovirimat for the treatment of human monkeypox virus (HMPXV) disease. The study will also include a cohort of people who will receive open-label tecovirimat including people with protocol-defined severe HMPXV, pregnant and br...

PHACS Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)

Childrens Hospital Colorado, University of Colorado Hospital

The study is designed to evaluate the health outcomes of women living with HIV over time. Women who elect to participate in this study complete a combination of online surveys, clinical assessments, and interviews, with a blood draw and other samples collected at the time a person enrolls ...

Gut microbiome effects on intestinal barrier function in metabolic syndrome in HIV positive men who have sex with men

Outpatient CTRC, University of Colorado Hospital

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease

Adult Infectious Disease Clinical Trials Center, Outpatient CTRC, University of Colorado Hospital

Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants ...

A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections - Appendix E-2: Immune Modulation Strategy Trial

Outpatient CTRC, University of Colorado Hospital

A Phase 2, Randomized, Double-blind, Placebo-controlled, 2-part Study To Evaluate EDP-938 Regimens In Subjects Aged 28 Days To 36 Months Infected With Respiratory Syncytial Virus (RSV)

Childrens Hospital Colorado

Study subjects will take an oral medication/placebo. Study activities include blood draws, nasal swabs, ECGs, and e-diary entries...

Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)

Childrens Hospital Colorado

Enrolling now through August 31st. This study is testing a nasal spray vaccine for RSV. Participants will need to attend 3-5 study visits, 2-4 blood draws, and e-diary entries to monitor for RSV-like illness. Participants will also need to return for any illness visits. ...

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