Clinical trials: Infection, Human Immunodeficiency Virus I, open to volunteers
HIV I Infection, Tuberculosis
Evaluating the Safety and Immunogenicity of MTBVAC
The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa
- Trial name
- HVTN605A5421 (NCT05947890)
- Testing
- MTBVAC, BCG
- Where
- 16 sites in South Africa
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
ANCA-IgG-positive ANCA Associated Vasculitis
Anti-CD 19 CAR-T Cell Therapy in Patients With ANCA Vasculitis
The goal of this phase I/II clinical trial is to investigate anti-CD 19 chimeric antigen receptor T cell (CAR-T cell) therapy in patients with antineutrophil cytoplasmic antibodies (ANCA) immunoglobulin (IgG) positive ANCA…
- Trial name
- IDEAL (NCT06590545)
- Testing
- KYV-101, an autologous fully-human anti-CD19 CAR T-cell immunotherapy
- Volunteers
- 8 people
- Sponsor
- David Simon
Behavioral Intervention, Viral Suppression of HIV Infection
Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial
Men who are living with HIV and use stimulants face many challenges and barriers that may interfere with remembering to take their HIV medication.
- Conditions
- Behavioral Intervention, Viral Suppression of HIV Infection, ART Adherence
- Trial name
- reSTART (NCT07125235)
- Testing
- reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention, urine tenofovir point-of-care self-test
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- University of California, San Francisco
HTLV-I Infection, Tropical Spastic Paraparesis
Evaluation of Patients With HAM/TSP
Objective: Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus.
- Trial name
- NCT00001778
- Where
- United States
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Hepatitis C
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection…
- Trial name
- NCT07040319
- Testing
- Glecaprevir/pibrentasvir
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV I Infection, Injection Pain
Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset
This is a multicenter, randomized, open-label study with a cross-over design. The objective of this project is to compare the intensity of pain induced by injectable antiretroviral (ARV) treatment (Cabotegravir® and Rilpivirine®)…
- Trial name
- VIHINJECT (NCT06834113)
- Testing
- Dorsogluteal intramuscular injection
- Where
- 5 sites in France
- Volunteers
- 120 people
- Sponsor
- Centre Hospitalier Régional d'Orléans
Kaposi Sarcoma
PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
Background: Kaposi sarcoma (KS) tumors grow on the skin, lymph nodes, lungs, bone, and gastrointestinal tract. KS often affects people with immune deficiencies, such as among people living with HIV or those with prior history of…
- Trial name
- NCT04303117
- Testing
- PDS01ADC, M7824
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- National Cancer Institute (NCI)
Kaposi Sarcoma
Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
Background: Kaposi Sarcoma (KS) is common in people with human immunodeficiency virus (HIV) but can also occur in people who do not have HIV.
- Trial name
- NCT04941274
- Testing
- Abemaciclib
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- National Cancer Institute (NCI)
Human Immunodeficiency Virus
Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults
This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered…
- Trial name
- RV591 (NCT06205056)
- Testing
- Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a], CH505 TF chTrimer + ALFQ [Arm 1a], Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a]
- Where
- Uganda
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
HIV I Infection
The Expand Study-Pharmacist Administered Long Acting Cabotegravir + Rilpivirine to Expand Access for People With HIV
The purpose of The EXPAND study is to develop and pilot a pharmacist led model of medication delivery. Following a co-design phase, patients may receive injections at satellite pharmacies by a licensed pharmacist.
- Trial name
- EXPAND (NCT06635421)
- Testing
- Model of care delivery for long-acting injectable ART
- Volunteers
- 164 people
- Sponsor
- MetroHealth Medical Center
Human Immunodeficiency Virus, Human Immunodeficiency Virus I Infection
HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
The goal of this randomized clinical trial is to evaluate the safety and immunogenicity of the HIV Therapeutic DNA Vaccine (ICVAX) in participants with HIV-1 infection under antiretroviral therapy (ART).
- Trial name
- NCT07530198
- Testing
- ICVAX (TERESA-EPT I device), ICVAX (PharmaJet Tropis device), ICVAX (TriGrid device)
- Where
- Hong Kong
- Volunteers
- 22 people
- Sponsor
- Immuno Cure Holding (HK) Limited
Hiv
DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)
The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously…
- Trial name
- DOR (NCT06034938)
- Testing
- Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
- Where
- 4 sites in France
- Volunteers
- 32 people
- Sponsor
- University Hospital, Caen
Viral Associated Malignancies, Kaposi Sarcoma
Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV
Background: Less toxic and more effective treatments are needed for cancers caused by viruses. These cancers include Hodgkin and non-Hodgkin lymphoma, hepatocellular carcinoma, head and neck cancer, nasopharyngeal carcinoma…
- Conditions
- Viral Associated Malignancies, Kaposi Sarcoma, EBV/KSHV-associated Lymphomas
- Trial name
- NCT04902443
- Testing
- Pomalidomide, Nivolumab
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- National Cancer Institute (NCI)
Healthy Volunteer
Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection.
- Trial name
- NCT03878121
- Testing
- Ad4-Env145NFL, Ad4-Env150KN, VRC-HIVRGP096-00-VP (Trimer 4571) with alum
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter…
- Trial name
- NCT05418868
- Testing
- Cabotegravir 200 mg/mL, CAB >=400 mg/mL, CAB Formulation I
- Where
- 3 sites in United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Seropositivity
Hybrid Type I Effectiveness-Implementation Trial of a Social Network Support Intervention
The goal of this Hybrid Type I effectiveness-implementation trial is to test an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression…
- Trial name
- NCT05723653
- Testing
- Social Network Support Intervention
- Where
- 7 sites in United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Diffuse Large Cell Lymphoma, Non-Hodgkin Lymphoma
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
Background: Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV.
- Conditions
- Diffuse Large Cell Lymphoma, Non-Hodgkin Lymphoma, Burkitt Lymphoma, Plasmablastic Lymphoma
- Trial name
- NCT05389423
- Testing
- Vincristine, Prednisone, Doxorubicin
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Cancer Institute (NCI)
HIV I Infection
Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France
For most people with HIV (PWH), an effective antiretroviral regimen can be devised. However, some PWH have multiple treatment failures due to viral resistance or unacceptable side effects to medication and no longer have durable…
- Trial name
- LENAddON (NCT06799338)
- Testing
- Lenacapavir Injection
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Tuberculosis
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB).
- Trial name
- NCT07124559
- Testing
- Rifapentine, Isoniazid, Dolutegravir
- Where
- 11 sites in Botswana, Haiti and 4 more
- Volunteers
- 144 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders
The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of…
- Trial name
- JL18008 (NCT07579741)
- Testing
- JL18008 20 μg/kg, JL18008 40 μg/kg, JL18008 70 μg/kg
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Jecho Biopharmaceuticals Co., Ltd.