See the list of NIAID clinical trials that are recruiting in the United States below or view the complete list of NIAID studies clinical studies on ClinicalTrials.gov.
Search Results
47 Results
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
This study is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI).
A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
The objective of this study is to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160.
A randomized placebo-controlled study to evaluate the safety and effects of repeated doses of 3BNC117-LS and 10-1074-LS on persistent viral reservoirs in people living with HIV and on suppressive antiretroviral therapy (LONGBNAB)
The purpose of this research study is to evaluate whether three doses of the two study drugs being tested, 3BN117-LS and 10-1074-LS, are safe and tolerable. This study will also evaluate if the study drugs change the numbers of blood cells that are infected with HIV while you are on antiretroviral therapy (ART). This pool of blood cells that contain dormant HIV is referred to as the persistent viral reservoir.
A Single arm Open Label Phase 2 trial of anti-CD4 Antibody UB-421 in Combination with Optimized Background Antiretroviral Therapy in Patients with Multi-Drug Resistant HIV-1 (UB-421)
The purpose of this study is: (1) to see if a drug called UB-421 is able to control human immunodeficiency virus (HIV) in patients with a virus that has become so resistant to anti-HIV drugs that an effective treatment regimen cannot be put together using drugs currently approved by the US Food and Drug Administration (FDA); and (2) to see if UB-421 is safe for patients with multiple-drug resistant HIV.
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
This study will test an anti-HIV drug (ARV) for newborn babies.
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.
Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
The purpose of this study is to collect blood plasma and white blood cells from individuals for laboratory research studies.
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
The purpose of this study is to investigate HIV infection and associated conditions by monitoring infected patients.
Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health
This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum. The primary hypothesis is that the boosting with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum will further mature broadly neutralizing antibody (bnAb)-precursor B-cell lineages elicited by 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum. 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum has been tested in HVTN 301 previously, whereas the HxB2.WT.Core-C4b will be first-in-human (FIH).
Consent for Use of Stored Patient Specimens for Future Testing
The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing.
Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort
The goal of the DC Cohort is to establish a clinic-based city-wide longitudinal cohort that will describe clinical outcomes, and improve the quality of care for outpatients with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) in Washington, DC.
Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers
The purpose of this study is to see how a common integrase strand transfer inhibitors (INSTI), dolutegravir (DTG), affects how the body uses energy.
ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments
To advance the Prevent objective of the Ending the HIV Epidemic (EHE) initiative, ED2PrEP will leverage an implementation science approach to rigorously test two innovative strategies for increasing PrEP uptake among patients seeking STI care in EDs in one of the 48 EHE-identified geographic hotspots.
Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus (ChAdV)- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the Toll-like Receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
The goal of this study is to see if Trimer 4571 is safe and well tolerated and to see if it will help the immune system produce broadly neutralizing antibodies (bnAbs) against HIV.
Finishing HIV Project
This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.
Help End HIV - Red Ribbon Registry
HIV remains a major health issue globally and within the United States. Recent audience research found that many Americans are not aware that HIV is still a health issue in the U.S., are unsure if they might be vulnerable to exposure, and do not know if there is a cure.
HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
The goal of this observational study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements.
Imaging and Biopsy of People Living with HIV-1 Undergoing Analytic Treatment Interruption (BATI)
If you join this study, you will have a scan called PET/CT to find the location of HIV-infected cells. Infected cells need energy to make more HIV, and PET/CT uses radiation to show what parts of the body are using energy.
Imaging Immune Activation in HIV by PET-MR
The primary endpoint of this study is to determine the anatomical distribution of [18F]F-AraG in HIV-infected individuals taking or not taking antiretroviral therapy.
Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure.
LTNP Study
A small group of people who are living with HIV remain healthy for long periods of time without medications. These people, known as Long-Term Non-Progressors (also referred to as Elite Controllers), have properties within their immune systems that control the virus. They can help researchers at the National Institutes of Health (NIH) in Bethesda, Maryland, determine how their immune systems control HIV disease.
MyPEEPS LITE Trial
The objective of this summary is to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators.