Clinical trials: Immunologic Deficiency Syndrome
HIV-1
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human…
- Trial name
- NCT03227861
- Testing
- DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
- Where
- 16 sites in United States
- Volunteers
- 109 people
- Sponsor
- Janssen Scientific Affairs, LLC
HIV/AIDS, Alcohol Abuse
Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa
This project aims to develop and pilot test an intervention using couple-based motivational interviewing (MI) and mobile breathalyzers to reduce heavy alcohol use with couples living with HIV in South Africa.
- Trial name
- NCT05756790
- Testing
- Motivational Interviewing, Motivational Interviewing plus Breathalyzer
- Where
- South Africa
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Infection, Human Immunodeficiency Virus
A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir
Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working properly and therefore prevents the virus…
- Trial name
- NCT00950859
- Testing
- GSK1349572 (Cohort I), GSK1349572 (Cohort II)
- Where
- 26 sites in United States, Canada and 3 more
- Volunteers
- 51 people
- Sponsor
- ViiV Healthcare
HIV Infection
Dipyridamole for Immune Activation in HIV
The purpose of this study is to determine if Dipyridamole (DP) will decrease inflammation in HIV-1-infected individuals who are already on antiretroviral treatment and have a low viral load.
- Trial name
- NCT02121756
- Testing
- Dipyridamole
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Sharon Riddler
Primary Immune Deficiency Disorder
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
- Trial name
- NCT01814800
- Testing
- RI-002
- Where
- 9 sites in United States
- Volunteers
- 59 people
- Sponsor
- ADMA Biologics, Inc.
HIV, HIV Infections
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing…
- Trial name
- NCT01815736
- Testing
- E/C/F/TAF, E/C/F/TDF, EFV/FTC/TDF
- Where
- 167 sites in United States, Australia and 18 more
- Volunteers
- 1,443 people
- Sponsor
- Gilead Sciences
HIV Infection
Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown…
- Trial name
- NCT01227395
- Testing
- Azithromycin
- Volunteers
- 476 people
- Sponsor
- Pfizer
Syphilis, HIV Infections
Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting
The purpose of this study is to determine if a strategy utilizing the Chembio HIV/syphilis rapid point-of-care (POC) test for diagnosis of HIV and syphilis in pregnant women attending prenatal clinics in Guatemala will increase…
- Trial name
- NCT07498153
- Testing
- Chembio HIV/Syphilis rapid POC test
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- The University of Texas Health Science Center, Houston
HIV Infections
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
The primary purpose of this study is to: 1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially diverse HIV+ population (males and females) who are three-class (nucleoside reverse transcriptase…
- Trial name
- NCT00440271
- Testing
- tipranavir, ritonavir, Optimized Background Regimen (OBR)
- Where
- 30 sites in United States, Argentina and 5 more
- Volunteers
- 33 people
- Sponsor
- Boehringer Ingelheim
Human Immunodeficiency Virus
Rapid HIV Treatment Initiation, Access and Engagement in Care
The investigators propose to evaluate Rapid HIV Treatment Initiation in Baltimore in newly and previously diagnosed HIV-positive patients not in care through identification of barriers, facilitators and acceptability of Rapid HIV…
- Trial name
- NCT03512964
- Testing
- Dolutegravir 50 MG, Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY]
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Johns Hopkins University
HIV Infections
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV.
- Trial name
- NCT00414518
- Testing
- Tenofovir disoproxil fumarate/Emtricitabine, Lopinavir/Ritonavir
- Where
- 3 sites in United States, Zimbabwe
- Volunteers
- 16 people
- Sponsor
- University of Colorado, Denver
Waning Donor Chimerism, Waning Immune Function
CD34+ Stem Cell Infusion to Augment Graft Function
The purpose of this study is to determine if infusing additional special donor cells will help to improve graft or immune function in previously transplanted children with immune deficiencies and bone marrow failures.
- Conditions
- Waning Donor Chimerism, Waning Immune Function, Primary Immunodeficiency Disease(s), Bone Marrow Failure
- Trial name
- NCT01856582
- Testing
- CD34+
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
GATA2, Immunodeficiency
Allogeneic Hematopoietic Stem Cell Transplantation With Briquilimab-Based Conditioning in Participants With GATA2 Deficiency
Background: People with GATA-binding factor 2 (GATA2) deficiency have a mutation on the GATA2 gene. This gene affects immune function.
- Trial name
- NCT05907746
- Testing
- Mycophenolate Mofetil, Tacrolimus, Post-Transplant Cyclophosphamide
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- National Cancer Institute (NCI)
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults.
- Trial name
- NCT05163522
- Testing
- VH4004280, Midazolam
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants: 1.
- Trial name
- PROMISE (NCT01061151)
- Testing
- Zidovudine (ZDV), Nevirapine (NVP): Antepartum Mothers, Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail
- Where
- 14 sites in India, Malawi and 5 more
- Volunteers
- 3,747 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
HIV Infections
Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was well-controlled with HIV medicines.
- Trial name
- NCT02463227
- Testing
- VRC01
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hereditary Angioedema
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
Primary Outcome Measures: The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase.
- Trial name
- FAST2 (NCT00500656)
- Testing
- Icatibant, Tranexamic Acid
- Where
- Italy
- Volunteers
- 85 people
- Sponsor
- Shire
HIV Infections, Adolescent Development
Tailored Motivational Interviewing Implementation-Effectiveness Trial in Multidisciplinary Adolescent HIV Care Settings
The goal of this study is to test a multi-faceted Tailored Motivational Interviewing Implementation intervention (TMI), based on the Dynamic Adaptation Process (DAP) to scale up an Evidence-based Practice (EBP) in…
- Conditions
- HIV Infections, Adolescent Development, Care Eliciting Behavior, Patient Non-Compliance
- Trial name
- TMI (NCT03681912)
- Testing
- Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS), Randomized Guided Development of COPs with an internal facilitator after one year of implementation., CoP development without internal facilitation.
- Where
- United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Florida State University
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.
- Trial name
- NCT00992836
- Testing
- Influenza A (H1N1) 2009 monovalent vaccine
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 155 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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