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HIV Infections clinical trials

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NCT ID: NCT06310616 Recruiting - HIV Infections Clinical Trials

A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants

Start date: March 6, 2024
Phase: Phase 1
Study type: Interventional

This study aims to assess any impact of VH4524184 on the pharmacokinetic (PK) profile of an ethinyl estradiol (EE) and norethindrone acetate (NEA) containing oral contraceptive (OC) administered to healthy adult female participants.

NCT ID: NCT06274632 Recruiting - HIV/AIDS Clinical Trials

ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization.

NCT ID: NCT06248190 Recruiting - Stroke Clinical Trials

ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE

ENHANCE
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are: 1. To test and estimate the effect of the intervention in people with MLTCs attending PHCs on: i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care 2. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance. 3. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention. The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.

NCT ID: NCT06230367 Recruiting - HIV Infections Clinical Trials

Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys

SHAG
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.

NCT ID: NCT06205511 Recruiting - Clinical trials for Human Immunodeficiency Virus

The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV

SWISH
Start date: April 1, 2023
Phase:
Study type: Observational

The study will evaluate 300 people living with HIV that attend the Vivent Clinic for HIV care. We will characterize our population and include age, race/ethnicity, sex at birth, tobacco use, alcohol use, other comorbidities, HPV vaccination status, other HPV disease, and lab values such as CD4 count and HIV viral load. We will compare results between participants who are HPV positive and negative. We will also evaluate the relationship between HPV oral infections and lesions and the variables above to better understand possible predictors of HPV infections and lesions.

NCT ID: NCT06176859 Recruiting - HIV Clinical Trials

Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.

NCT ID: NCT06168318 Recruiting - HIV Infections Clinical Trials

A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy Participants

Start date: December 18, 2023
Phase: Phase 1
Study type: Interventional

This is a 2 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Part 1 of the study will compare the relative bioavailability of VH4004280 Formulation A tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. Part 2 of the study will assess the effect of fasted conditions on the bioavailability of VH4004280 Formulation A and alternative, optional formulations, relative to their respective bioavailability under fed conditions in Part 1.

NCT ID: NCT06155019 Recruiting - HIV Infections Clinical Trials

Switch From Etravirine to Doravirine as a Part of Antiretroviral Combination

SWEED
Start date: December 15, 2023
Phase:
Study type: Observational

The main objective of the SWEED study is to determine whether doravirine containing ART is able to maintain viral suppression at W48 in HIV-1 infected people living with HIV (PLWH) receiving etravirine containing ART: - An ARV strategy containing doravirine as a replacement for etravirine can maintain virological suppression in participants with controlled viral replication under ARV treatment containing etravirine, with a virological success rate >90% - This strategy can maintain virological suppression even in the event of NNRTI resistance mutations acquired in the past - This strategy is well tolerated - The emergence of resistance to NNRTIs is uncommon in the event of virological failure under the ARV regimen containing doravirine

NCT ID: NCT06139497 Recruiting - HIV Infections Clinical Trials

Feasibility and Effectiveness of a Pilot Program of Physical Activity to Improve HIV Related Functional Limitations and Disability in Adults Aged 40 and Older From Côte d'Ivoire

VIRAGE+
Start date: October 31, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional study is to document the importance of HIV-related disabilities, notably the frequency / nature of functional limitations, neurocognitive impairments, and restrictions of social participation in adults living with HIV aged 40 and older. Participants will undergo a comprehensive set of cognitive and functional assessments, and approximately twenty particpants will be asked to participate in an anthropological survey conducted through structured interviews. Researchers will a group of people living with HIV and o reference group without HIV infection.

NCT ID: NCT06139224 Recruiting - Clinical trials for Alcohol Use Disorder

Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection

Start date: March 6, 2024
Phase: N/A
Study type: Interventional

Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation. Our preliminary data using intestinal organoids also suggest a potential mechanism for AUD-mediated changes in the gut barrier function during HIV; the intestines of HIV+ individuals have low resilience to alcohol induced intestinal barrier disruption caused by high levels of oxidative stress. Finally, our preliminary data also suggest a potential approach to enhance the integrity of the intestinal barrier and reduce gut derived inflammation in people living with HIV with/without AUD- short chain fatty acid prebiotics. These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe and decrease gut inflammation in humans. 20 HIV+ ART+ (10 AUD- and 10 AUD +), will be recruited for a prebiotic intervention. This is a proof-of-concept observational study to establish a causal link between microbiota-gut and HIV pathology during ART by asking whether modifying microbiota and gut milieu impacts intestinal barrier function, systemic inflammation, and brain pathology in HIV+ people. Participants will have two study visits, where stool collection and blood draw will be collected, as well as questionnaires. These participants are part of the larger observation study (n=160), which will test the hypothesis that intestines from HIV+ individuals have lower resilience to alcohol mediated gut barrier disruption than intestines from HIV-negative controls. We will recruit the following groups of participants: HIV+ ART+ AUD-; HIV+ ART+ AUD+; HIV- AUD- ; HIV- AUD+. Blood, urine, stool, and intestinal biopsies will be collected from participants to compare intestinal barrier integrity, system and gut inflammation, immune activation, oxidative stress, microbiome/metabolome. and HIV reservois. Second, lleal/colonic organoids from HIV- and HIV ART+ individuals will be generated to examine their resilience to alcohol-induced intestinal barrier disruption.