HIV/AIDS clinical trials at UCSD
51 in progress, 29 open to eligible people
Systems Analysis and Improvement Approach for Optimizing HIV Service Delivery in Syringe Services Programs
open to eligible people ages 18 years and up
The goal of this clinical trial is to assess the effectiveness of an evidence-based, organizational-level implementation strategy, the Systems Analysis and Improvement Approach, in improving HIV service delivery (SAIA-SSP-HIV) in U.S. syringe…
San Diego, California
ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
open to eligible females ages 25-64
While there has been a significant increase in the uptake of antiretroviral therapy among women living with HIV (WLHIV) in many low- and-middle income countries (LMICs), the coverage of cervical cancer screening and treatment (CCST) among WLHIV…
La Jolla, California and other locations
Cannabis Effects on Antiretroviral Therapy Pharmacokinetics and Neurotoxicity
open to eligible people ages 18 years and up
This study will address whether cannabis affects antiretroviral therapy (ART) drug concentrations, mood, and thinking. The project will have two phases. Phase 1 is an observational study, in which 120 people will be assessed to evaluate the effects…
San Diego, California
Cannabis Use, Cognition, and the Endocannabinoid System in HIV
open to eligible people ages 18-65
Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence…
San Diego, California
CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS
open to eligible people ages 18 years and up
Human immunodeficiency virus type 1 (HIV-1) causes a persistent infection that ultimately leads to acquired immunodeficiency syndrome (AIDS). Treatment of HIV-1 infection with combination anti-retroviral therapy (ART) suppresses HIV-1 replication to …
San Diego, California and other locations
Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
open to eligible people ages 30 years and up
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, …
San Diego, California and other locations
Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
open to eligible people ages 21-70
This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and…
San Diego, California
Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
open to eligible people ages 18 years and up
The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential…
San Diego, California and other locations
Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas
open to eligible people ages 18 years and up
This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus…
La Jolla, California and other locations
Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living with HIV: a Feasibility Study
open to eligible people ages 45-80
This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help…
La Jolla, California and other locations
Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care
open to eligible people ages 18 years and up
Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP).…
San Diego, California and other locations
Prevention Ambassadors: Intervention to Promote HIV Service Engagement in the Networks of SSP Clients
open to eligible people ages 18 years and up
HIV testing and service uptake are infrequent among people who use drugs (PWUD) in the United States. In partnership with a community-based syringe service program (SSP), this project will develop the SSP-based "Prevention Ambassadors" (PA)…
San Diego, California
Role of CBD in Improving Alexithymia
open to eligible people ages 21 years and up
Given the treatments that are available today for HIV disease, people living with HIV (PLWH) can generally expect good medical outcomes. However, HIV is still a chronic disease and there are remaining barriers to achieving ideal health status and…
San Diego, California
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
open to eligible people ages 18 years and up
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an…
San Diego, California and other locations
Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
open to eligible people ages 18 years and up
The goals of this clinical study are to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for pre-exposure prophylaxis (PrEP) in people who inject drugs…
San Diego, California and other locations
Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
open to eligible females ages 18 years and up
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US. The primary…
San Diego, California and other locations
Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV
open to eligible people ages 18-70
The study aims to assess safety and tolerability of oral toll-like receptor (TLR) 8 agonist Selgantolimod (SLGN) administered for 24 weeks in participants with both CHB and HIV who have been receiving suppressive antiviral therapy for both viruses…
San Diego, California and other locations
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
open to all eligible people
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.
La Jolla, California and other locations
Women Focused Encounters for Resilience Independence Strength and Eudaimonia
open to eligible females ages 18 years and up
The goal of this combination Type 1 hybrid and observational study is to evaluate the impact of a peer delivered intervention of acceptance and comittment therapy(ACT) + exercise + social support to address the substance (ab)use, violence, and…
San Diego, California
Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
open to eligible females ages 18 years and up
A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal…
La Jolla, California
Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
open to eligible people ages 18 years and up
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or…
San Diego, California and other locations
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
open to eligible people ages 18 years and 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…
La Jolla, California and other locations
Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
open to eligible people ages 18 years and up
This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors …
La Jolla, California and other locations
Consent for Use of Stored Patient Specimens for Future Testing
open to all eligible people
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.
San Diego, California and other locations
Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
open to all eligible people
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. Up to approximately 250 participants will be in the study for…
San Diego, California and other locations
Nonalcoholic Fatty Liver Disease in HIV Database
open to eligible people ages 18 years and up
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. The spectrum of NAFLD…
San Diego, California and other locations
Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
open to eligible females
The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.
San Diego, California and other locations
Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV
open to eligible people ages 18-80
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. NAFLD is the most…
La Jolla, California and other locations
Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
open to eligible people ages 18 years and up
This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials.…
La Jolla, California and other locations
Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
Sorry, not currently recruiting here
A5388 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) in order to determine whether: - Administration of combination HIV-specific …
San Diego, California and other locations
GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Sorry, in progress, not accepting new patients
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872)) with lenacapavir (LEN) in virologically…
San Diego, California and other locations
MHealth Intervention to Improve HIV Prevention Service Engagement Among Racially Diverse Women Who Use Drugs
Sorry, not yet accepting patients
The goal of this pilot randomized controlled trial is to assess the feasibility, acceptability, and preliminary impact of the mHeaLth interventiOn To redUce Stigma (LOTUS) intervention to improve HIV prevention service engagement and reduce…
La Jolla, California
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma
Sorry, in progress, not accepting new patients
This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus…
La Jolla, California and other locations
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
Sorry, not yet accepting patients
This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people …
La Jolla, California and other locations
Early ART to Limit Infection and Establishment of Reservoir
Sorry, in progress, not accepting new patients
The study was done to: - Start antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1 - See how starting ART as soon as the infection is found affects the amount of HIV-1 in blood and how well the body fights the HIV-1…
San Diego, California and other locations
Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP…
San Diego, California
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
Sorry, not currently recruiting here
Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy…
San Diego, California and other locations
Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant
Sorry, in progress, not accepting new patients
This phase I/II trial studies the side effects and best dose of gene therapy in treating patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to therapy or came back after an original response receiving stem cell…
La Jolla, California and other locations
HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients
Sorry, in progress, not accepting new patients
The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications
San Diego, California and other locations
Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
Sorry, not currently recruiting here
This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.
San Diego, California and other locations
LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Sorry, in progress, not accepting new patients
Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that…
San Diego, California
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
Sorry, not yet accepting patients
A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive…
San Diego, California and other locations
Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy
Sorry, not yet accepting patients
A5422 is a phase 1, randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, and immunogenicity of a vaccination with stabilized CH505 TF chTrimer admixed with 3M-052-AF + Aluminum hydroxide (Alum), to assess…
San Diego, California and other locations
IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption…
San Diego, California and other locations
B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
Sorry, in progress, not accepting new patients
The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed…
San Diego, California and other locations
Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
Sorry, in progress, not accepting new patients
The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.
San Diego, California and other locations
Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Sorry, in progress, not accepting new patients
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3)…
San Diego, California and other locations
Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Sorry, in progress, not accepting new patients
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)…
San Diego, California and other locations
LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
Sorry, in progress, not accepting new patients
The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART)…
San Diego, California and other locations
Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)
Sorry, in progress, not accepting new patients
Participants will be randomized in a 2:1 ratio to receive either two injections of CMV-MVA Triplex® or placebo administered at study Entry/Day 0 and week 4. Vaccine Group: 60 participants will receive CMV-MVA Triplex® containing 5 x 10^8…
San Diego, California and other locations
Health Information for Infected Veterans
Sorry, in progress, not accepting new patients
This is a study of My HealtheVet (MHV) use by Veterans diagnosed with Human Immunodeficiency Virus (HIV) and VA providers/staff who care for them. The investigators hope to learn and understand how MHV can improve the self-management of chronic…
San Diego, California and other locations
Our lead scientists for HIV/AIDS research studies include Nimish Patel, MD Ronald J Ellis, MD, PhD Sheldon Morris, MD Rohit Loomba, MD David (Davey) Smith, MD Arpi Minassian, Ph.D. Erin Reid, MD Maile Karris, MD Saima Aslam, MBBS Stephen Spector, MD Scott Letendre, MD Jamila K Stockman, PhD, MPH Angela Bazzi Gregory Aarons, PhD.
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