Clinical trials: Immunodeficiency
HIV Infections, Behavioral Symptoms
Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam
This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese…
- Conditions
- HIV Infections, Behavioral Symptoms, Depression, Anxiety
- Trial name
- VITAL (NCT04790201)
- Testing
- Friendship Bench Delivered by Professional Counselor, Friendship Bench Delivered by Lay Counselor, Enhanced Usual Care
- Where
- Vietnam
- Volunteers
- 77 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine
Dolutegravir (DTG) plus lamivudine (3TC) is a dual regimen combination recommended for both naïve and suppressed persons with HIV-1 infection1.
- Trial name
- VOLVER (NCT04880785)
- Testing
- Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]
- Where
- 17 sites in Spain
- Volunteers
- 167 people
- Sponsor
- Fundacion SEIMC-GESIDA
Hereditary Angioedema
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
- Trial name
- KONFIDENT-KID (NCT06467084)
- Testing
- KVD900 150 mg, KVD900 300 mg, KVD900 600 mg
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 36 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
HIV/AIDS
ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-Adherence
Purpose: Perform a 3-phase (single dose, multi dose, dose proportionality) study in healthy volunteers using daily tenofovir+emtricitabine, dolutegravir, and maraviroc dosing to quantify intra- and inter-subject variability and…
- Trial name
- ENLIGHTEN (NCT03218592)
- Testing
- Maraviroc Pill, Dolutegravir Pill, Truvada Pill
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Human Immunodeficiency Virus, Hypertension
Integration of Hypertension Management Into HIV Care in Nigeria
This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers…
- Trial name
- TASSH NIMR (NCT04704336)
- Testing
- Task-shifting strategy for HTN control (TASSH) protocol
- Where
- 2 sites in United States, Nigeria
- Volunteers
- 830 people
- Sponsor
- NYU Langone Health
Tuberculosis, HIV Infections
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana.
- Trial name
- NCT00164281
- Testing
- Isoniazid
- Where
- Botswana
- Volunteers
- 1,995 people
- Sponsor
- Centers for Disease Control and Prevention
HIV Associated Cognitive Motor Complex
Effect of Galantamine on Inflammation and Cognition
This study tests whether galantamine (GAL) reduces HIV-related inflammation and cognitive deficits. In this double-blind placebo-controlled crossover study, HIV-infected individuals (N=120; 60 smokers and 60 non-smokers) will be…
- Trial name
- CHI (NCT03384784)
- Testing
- Galantamine
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Pennsylvania
Severe Combined Immunodeficiency Due to ADA Deficiency
Efficacy and Safety of the Cryopreserved Formulation of OTL-101 in Subjects With ADA-SCID
This is a prospective, non-randomized, single-cohort, longitudinal, single-center, clinical study designed to assess the efficacy and safety of a cryopreserved formulation of OTL-101 (autologous CD34+ hematopoietic…
- Trial name
- NCT02999984
- Testing
- Infusion of autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101), busulfan, PEG-ADA ERT
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, Los Angeles
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in…
- Trial name
- PILLAR (NCT05374525)
- Testing
- APRETUDE, Cabotegravir OLI
- Where
- 17 sites in United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response
This research is a feasibility pilot of an intervention to respond to positive screening tests for mental health(MH) and substance use (SU) captured through the Patient Reported Outcomes questionnaires (PROs).
- Trial name
- PROACT (NCT03067948)
- Testing
- Patient Designated Positive Screen Shared with Provider
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Johns Hopkins University
HIV Infections
The Women TDF-FTC Benchmark Study
The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated…
- Trial name
- NCT05057858
- Testing
- co-formulated 300 mg TDF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Washington
Leukemia, Leukemia, Lymphoblastic
Observational Study of People Living With HIV Treated With CD19-directed CAR T Cell
This protocol will develop an observational cohort of PLWH who have been or are being treated with CAR19 therapy outside of an AMC clinical trial.
- Conditions
- Leukemia, Leukemia, Lymphoblastic, Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma
- Trial name
- CS22-03 (NCT05784415)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- AIDS Malignancy Consortium
Human Immunodeficiency Virus
Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients.
- Trial name
- NCT01097655
- Volunteers
- 3,049 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
HIV/AIDS, Pregnancy Related
CareConekta: A Smartphone App to Improve Engagement in HIV Care
Population mobility is common in South Africa, but important research gaps exist describing this mobility and its impact on engagement in HIV care, particularly among pregnant and postpartum women.
- Trial name
- NCT03836625
- Testing
- CareConekta
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Healthy
Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type…
- Trial name
- NCT02315703
- Testing
- Ad26.Mos.HIV, MVA-Mosaic, gp140 DP Low-dose
- Where
- 12 sites in United States, Rwanda and 3 more
- Volunteers
- 393 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Cytomegalovirus Infections, HIV Infections
Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)
A5355 was a randomized, placebo-controlled study conducted at US sites to evaluate the safety and immunogenicity of two injections of the study drug Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine…
- Conditions
- Cytomegalovirus Infections, HIV Infections, Vaccine
- Trial name
- NCT05099965
- Testing
- CMV-MVA Triplex
- Where
- 12 sites in United States
- Volunteers
- 94 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hiv, HIV Infections
Standardized Patients to Measure and Address Intersectional Stigma
This study aims to develop and evaluate an intervention to reduce enacted stigma in healthcare settings aimed at people living with HIV (PLWH) and men who have sex with men (MSM) in China.
- Conditions
- Hiv, HIV Infections, AIDS
- Trial name
- NCT04896216
- Testing
- Stigma Reduction Intervention
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- University of Minnesota
HIV Disease, Bipolar Disorder
Texting to Improve Adherence in HIV+ With Bipolar Disorder
Adherence to combination antiretroviral therapy (ART) is critical for successful HIV viral suppression. Nonadherence to ART poses several potentially serious health consequences, including higher viral loads, faster progression…
- Trial name
- iTAB (NCT02090634)
- Testing
- Psychoeducation, individualized Texting for Adherence Building (iTAB)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- University of California, San Diego
HIV, AIDS
Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women
The purpose of this study is to try to understand and explain why HIV-infected and uninfected women who use cannabis (marijuana) currently, or have used cannabis in the past, have higher risk of having experienced a fall in our…
- Conditions
- HIV, AIDS, Aging
- Trial name
- NCT03633721
- Testing
- Cannabis
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
Sexually Transmitted Infection, HIV/AIDS
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes.
- Conditions
- Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes
- Trial name
- NCT04446611
- Testing
- First antenatal care + test-of-cure, First antenatal care + week 30-34 gestation (no test-of-cure)
- Where
- South Africa
- Volunteers
- 2,247 people, healthy volunteers welcome
- Sponsor
- Foundation for Professional Development (Pty) Ltd
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