Clinical trials: Immunodeficiencies
Infection, Human Immunodeficiency Virus, HIV Infections
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir…
- Trial name
- NCT02831764
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 722 people
- Sponsor
- ViiV Healthcare
Hereditary Angioedema
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema
The purpose of this study was to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with…
- Trial name
- NCT04307381
- Testing
- Donidalorsen
- Where
- 7 sites in United States, Netherlands
- Volunteers
- 20 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
HIV Infections, Depression
Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their…
- Trial name
- NCT00285584
- Testing
- Bupropion
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- NYU Langone Health
HIV Infections
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
This study evaluated the effects of tamoxifen exposure in combination with vorinostat on viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on antiretroviral therapy (ART), when compared to…
- Trial name
- NCT03382834
- Testing
- Tamoxifen, Vorinostat, Antiretroviral drugs
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 31 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS, Sexually Transmitted Diseases
Innovative Tools to Expand HIV Self-Testing
The I-TEST study builds upon two participatory approaches, open challenge contests and entrepreneurship training. The study utilizes open challenge contest to generate youth-driven interventions on strategies to promote HIV…
- Trial name
- I-TEST (NCT04070287)
- Testing
- SMART Pack, Luv Box, Bili Vibes
- Where
- Nigeria
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
HIV, AIDS
Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the impact of a situated treatment adherence intervention program among persons living with HIV/AIDS on antiretroviral therapy in Estonia.
- Conditions
- HIV, AIDS, Medication Adherence
- Trial name
- NCT01789138
- Testing
- Situated Optimal Adherence Intervention
- Where
- 2 sites in Estonia
- Volunteers
- 519 people
- Sponsor
- University of Tartu
HIV Infections
China Antiretroviral Treatment Adherence for Life
This study focuses on collecting and analyzing quantitative data related to adherence to antiretroviral treatment from patients in Dali, China, over a one-year time-frame and generating preliminary data on an intervention…
- Trial name
- AFL (NCT00661258)
- Testing
- Electronic drug monitoring feedback data
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Boston University
HIV Infections
Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy…
- Trial name
- NCT01302847
- Testing
- DTG film-coated tablets, DTG granules for suspension, DTG dispersible tablets
- Where
- 33 sites in United States, Botswana and 6 more
- Volunteers
- 181 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS
Impact of Metformin on Immuno-virologic Parameters in HIV
Non-diabetic, aviremic HIV-infected individuals on antiretroviral therapy (ART) will be randomized to metformin therapy or to observation for 72 weeks.
- Trial name
- NCT04500678
- Testing
- Metformin
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Hawaii
HIV/AIDS, Housing Problems
Enhanced Housing Placement Assistance
Randomized controlled trial of housing placement assistance for homeless persons with HIV
- Trial name
- EHPA (NCT03334825)
- Testing
- Enhanced housing placement assistance, Standard housing placement assistance
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- New York City Department of Health and Mental Hygiene
HIV Disease
Autonomic Neuropathy, GI Motility, and Inflammation in HIV
The purpose of this study is to explore a possible link between the autonomic nervous system and immune function in patients with HIV.
- Trial name
- ANGI (NCT02850276)
- Testing
- Pyridostigmine
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Primary Immunodeficiency Diseases (PID)
Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects
The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary…
- Trial name
- NCT00546871
- Testing
- Immune Globulin Intravenous (Human), 10%
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- Baxalta now part of Shire
AIDS-Related-Primary Central Nervous System Lymphoma
Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma
This study will investigate the use of chemotherapy plus highly active antiretroviral therapy (HAART) in patients with Acquired Immunodeficiency Syndrome (AIDS)-related primary brain lymphoma.
- Trial name
- NCT00267865
- Testing
- Methotrexate, Rituximab, Leucovorin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
HIV Infections
Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
- Trial name
- NCT04177355
- Testing
- BG505 SOSIP.664 gp140, 3M-052-AF, CpG 1018
- Where
- 10 sites in United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients…
- Trial name
- NCT00561925
- Testing
- nevirapine IR, nevirapine XR
- Where
- 202 sites in United States, Argentina and 19 more
- Volunteers
- 1,068 people
- Sponsor
- Boehringer Ingelheim
HIV Infections, Health Volunteers
A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and…
- Trial name
- NCT02990325
- Testing
- ABX464 150mg, ABX464 50mg
- Where
- Spain
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Abivax S.A.
HIV Infections
Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants
The purpose of this study is to evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.
- Trial name
- VRC07-523LS (NCT03735849)
- Testing
- VRC07-523LS
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens.
- Trial name
- NCT03682848
- Testing
- DTG + 3TC FDC
- Where
- 8 sites in Kenya, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily…
- Trial name
- NCT04233216
- Testing
- ISL, DOR, DOR/ISL
- Where
- 98 sites in United States, Australia and 16 more
- Volunteers
- 35 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers
This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts.
- Trial name
- NCT03441984
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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