HIV Infections Clinical Trials

The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA \[Ribonucleic Acid\] \< 50 \[cells per milliliter\] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg). Read Less

This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are: 1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence. 2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users. 3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users. Read Less

This real-world retrospective study describes the clinical efficacy of 2DR (DOVATO® (DTG/3TC)) versus 3DR (BIKTARVY® (BIC/F/TAF)) in PWH, including those with at least 2 social determinants of health indicators, across a multi clinic infectious disease organization in the Southeast United States Read Less

This study is designed to test the hypothesis that, compared to oral PrEP, use of CAB-LA in underserved populations in a real-world setting supported by a digital health companion program will be associated with greater medication adherence, persistence, retention-in-care, and improved PROs. Patients in the study will receive current standard care for HIV prevention and be offered enrollment in the digital health companion program. Goal of the study is to evaluate medication adherence and persistence in patients receiving CAB-LA vs oral PrEP and who engage with a digital health companion program. Read Less

In this study, "PrEP Intervention for people who Inject Substances and Use Methamphetamine" (PRIME), we propose to assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people assigned male sex at birth who inject methamphetamine adhere to PrEP. We will randomize 140 adults who use methamphetamine, are HIV-negative, and have recently engaged in a sexual HIV risk behavior to VDOT-CM or counseling alone for 24 weeks. The study aims are to (1) determine the efficacy of VDOT-CM compared to counseling alone for PrEP adherence, (2) evaluate the acceptability of PrEP and adherence support strategies among the cohort, and (3) compare injection or chemsex and sexual HIV risk behavior before and during PrEP use. We hypothesize that participants randomized to VDOT-CM will have superior adherence to PrEP. We also hypothesize that participants will describe barriers to and facilitators of PrEP adherence, and those who are randomized to VDOT-CM will consider it an acceptable PrEP adherence support strategy. Finally, we do not expect to find increased injection, chemsex, or sexual risk behaviors for HIV among study participants after they begin taking PrEP. Read Less

The purpose of this study is to use information technology (IT) to support the delivery of HIV prevention and care best practices in the dental care setting to meet the Department of Health and Human Services (DHHS) Ending the HIV Epidemic (ETE) goals. Read Less

The purpose of this research study is to understand why certain HIV medication regimens (called anti-retroviral or ARV medications) cause more weight gain than others. In this research, the investigators will compare micro-RNA profiles of people who take Symtuza(darunavir(D)/cobicistat(C)/emtricitabine(F)/tenofovir alafenamide (TAF))\[D/C/F/TAF\] with those who take Biktarvy(bictegravir(B)/emtricitabine(F)/tenofovir alafenamide (TAF))\[B/F/TAF\] and try to correlate this with the change in body weight and BMI over a course of 48 weeks. The investigators will also attempt to monitor the calorie intake of the participants in the two groups and correlate it with treatment-induced weight gain. Micro-RNAs are small molecules that are produced naturally in the human body, and which are responsible for modifying the expressions of genes. They have the potential to be used in diagnostic and therapeutic medicine and their putative role has been explored in many diseases across many clinical trials. By doing this research, the investigators hope to learn more about their role in HIV disease and its correlation with treatment-induced weight gain. Read Less

Despite advances in HIV diagnostics, care and prevention strategies, infection rates among adolescent and young adult sexual and gender minorities (SGM) continue to rise in the United States (US). There is an urgent need to describe the epidemiology and trajectories of HIV acquisition in this population and to offer age and culturally appropriate scalable prevention interventions to those at highest risk of infection in the US. This project will engage and retain young SGM in an innovative longitudinal cohort, enroll participants in a dynamic established digital health retention platform (HMP; HealthMPowerment), monitor HIV risk and prevention behaviors and explore the socioecological factors that influence the use of new HIV prevention technologies (UG3 phase), while also allowing targeted testing of novel digital health interventions (UH3 phase). In Aim 1, the investigators will enroll and retain a large (n=6000; 3000/year), diverse cohort of sexually active, SGM adolescents and young adults, ages 13-34, using innovative digital recruitment, engagement and retention strategies. Over the course of the study, the investigators will longitudinally characterize the sexual behavior, HIV transmission risk, and PrEP uptake trajectories of SGM youth utilizing epidemiological trajectory analyses to identify the most effective points of intervention (Aim 2). This study will capitalize upon productive existing partnerships and digital health expertise to articulate the drivers of the ongoing HIV epidemic among the most vulnerable populations in the US in order to identify the most effective, expeditious and scalable strategies to address this ongoing public health crisis. Read Less

The APR began as the 'Zidovudine in pregnancy Registry' in January 1989 and became the 'Antiretroviral Pregnancy Registry' in January, 1993. The purpose of the APR is to detect any major teratogenic effects involving any of the Registry drugs when administered to pregnant HIV positive women. The Registry is intended to provide an early signal of teratogenicity associated with prenatal use of the antiretroviral drugs. The Registry collects data on prenatal exposures to antiretroviral drugs, potential confounding factors (such as maternal age, disease status during pregnancy), and information about the outcome of the pregnancy. The Registry is managed by INC Research. The scientific conduct and analysis of the Registry data are overseen by an independent Advisory Committee consisting of members from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the academic sector. Registry data are obtained from participating providers who encompass physicians in private practice as well as hospitals and community clinics. The registry is co-sponsored and co-funded by 26 pharmaceutical companies that manufacture drugs used in ART. For an updated version of the registry, please see NCT00404989. Read Less