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HIV Infections clinical trials

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NCT ID: NCT04364035 Completed - HIV/AIDS Clinical Trials

Safety, Tolerability and Immunogenicity of MVA.HTI and ChAdOx1.HTI With Vesatolimod in HIV-1 Positive Patients

AELIX-003
Start date: February 20, 2020
Phase: Phase 2
Study type: Interventional

AELIX-003 study aims to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing AELIX Therapeutics' HTI T-cell vaccines and Gilead´s Toll-Like Receptor 7 (TLR7) agonist vesatolimod in HIV-infected individuals on antiretroviral therapy. Study that will be conducted in 57 participants who have started antiretroviral therapy during early HIV infection, enrolled at various clinical trial sites in Spain. All participants will be on antiretroviral therapy upon starting the study, with their HIV viral loads <50 copies/mL. Following exposure to the vaccine/vesatolimod, all participants, under careful monitoring, will temporarily stop their antiretroviral drugs to determine if the intervention is effective in keeping their HIV levels under control.

NCT ID: NCT04363411 Completed - Hepatitis c Clinical Trials

Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections

RUNtoBBV
Start date: October 25, 2018
Phase: N/A
Study type: Interventional

Title Reaching out to the UNdiagnosed people infected with blood-borne viral infections (RUNtoBBV) Objectives 1. To study the efficacy of an outreach methodology to increase the uptake for screening, linkage to care and treatment in (active or former) people who use drugs (PWUD) Trial design Prospective multicenter interventional cohort design Number of subjects 336 inclusions (with prevalence of HCV Ab: 30%) - 168 Antwerp - 168 Limburg Selection criteria Inclusion criteria: - 18 years of age - History of/ or active drug use - Written informed consent obtained Exclusion criteria - Currently enrolled in centralized OST program of Free Clinic or CAD Limburg Endpoints The following endpoints will be compared between the centers in Limburg and Antwerp: (Main outcome in bold) Main objectives: - Prevalence of blood-borne viral infections in Belgian (former or active) PWUD: - HCV infection (number of HCV Ab+ / number of screened PWUD) - HBV infection (number of HBsAg+/number of screened PWUD) - HIV infection (number of HIV Ab+/number of screened PWUD) - Analysis of linkage to care to hepatologist/ infectiologist (number of patients who adhered to their consultation/number of referred patients) Secondary objectives: - Analysis of risk behavior/sociodemographics linked to presence of BBV infections - Analysis of uptake of anti(retro)viral treatment (number of patients started on treatment/number of patients needing treatment) - Analysis of treatment adherence (adherence to treatment consultations/total planned consultations) - Analysis of treatment outcome (total number of cured or virally suppressed patients/total number of treated patients)

NCT ID: NCT04320186 Completed - HIV Infections Clinical Trials

Community Influences Transitions in Youth Health (CITY) Health II - Center for the Study of Community Health

CH-II
Start date: April 3, 2015
Phase: N/A
Study type: Interventional

The purpose of this protocol is to develop and evaluate an HIV prevention Entertainment Education (EE) intervention aimed at reaching underserved, at-risk African Americans, aged 18-25 years, living in disadvantaged urban neighborhoods in the Birmingham area.

NCT ID: NCT04318210 Completed - HIV Infections Clinical Trials

Open Label Extension (OLE) of the TDF2 Study, Botswana

TDF2-OLE
Start date: October 2012
Phase: N/A
Study type: Interventional

This study is an open label and is an extension to the TDF2 study in which the investigators offered daily oral tenofovir/emtricitabine (TDF/FTC) for a maximum of 12 months to HIV uninfected former participants of the TDF2 study.

NCT ID: NCT04314414 Completed - HIV Infections Clinical Trials

Coaching for HCV and HIV

Start date: December 20, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment initiation, and evaluation for HIV pre-exposure prophylaxis (PrEP) (when applicable) among individuals with a history of opioid use disorder accessing a substance use low-barrier-to-access (LBA) walk-in clinic. In-depth interviews will be administered to participants at baseline, three- and six-months for study participants (40 total participants). The investigator will also follow-up with the per recovery coach and administer surveys to assess the feasibility of a peer recovery coaching intervention in improving HCV/HIV related linkage to care and management. Patient medical records and peer recovery coach monthly reports will be accessed and reviewed to determine fidelity to research protocols.

NCT ID: NCT04303156 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)

Start date: June 18, 2020
Phase: Phase 1
Study type: Interventional

This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to participants in good health.

NCT ID: NCT04298697 Completed - Clinical trials for Human Immunodeficiency Virus

Biomarkers for Event-driven PrEP Adherence

Start date: February 28, 2020
Phase: Phase 4
Study type: Interventional

This study aims to recruit 20 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will be involved in the study for up to 24 weeks.

NCT ID: NCT04297501 Completed - HIV Infections Clinical Trials

Gut Microbiota Changes of HIV Patients Before and After One Year of ART

Start date: March 1, 2018
Phase:
Study type: Observational

HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Many studies have revealed strong and characteristic compositional differences in gut microbiota between individuals with HIV infection and seronegative controls. So far, several probiotic organisms have shown the ability to enhance intestinal epithelial barrier functions, reduce inflammation, and support effective Th-1 responses. Probiotics mainly stimulates polymeric IgA secretion, avoid bacterial overgrowth and their translocation, and produce a self-limited inflammatory response through development of regulatory T (Treg) cells by anti-inflammatory cytokine production. Therefore, we design a prospective, randomized, double-blind, placebo-controlled study to determine whether the use of a probiotic can expand beneficial microbiota that aid in decreasing bacterial translocation and pro-inflammatory cytokine production, thereby improving immune functions in HIV-infected subjects. Participants in the intervention group will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily, while those in the placebo group will take placebo which contains no probiotic but has the same flavor and characteristics as the probiotic product.. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 12 months of receiving intervention will be analyzed.

NCT ID: NCT04296331 Completed - HIV/AIDS Clinical Trials

HIV Jail POC-AgAB Testings

Start date: October 14, 2019
Phase:
Study type: Observational

"Enhancing a universal testing and treatment strategy in jail to promote viral load suppression among justice-involved people living with HIV" is an observational research study led by Dr. Matthew Akiyama, MSc of Albert Einstein College of Medicine and Montefiore Medical Center and Dr. Anne Spaulding, MPH of Emory University's Rollins School of Public Health. Due to the high rates of undiagnosed Human Immunodeficiency Virus (HIV) in the correctional setting and the short length of stay in jails, this study aims to evaluate whether care coordination within the D.C. Central Detention Facility (DC DOC) and upon release, including testing procedures and antiretroviral therapy (ART) initiation, can improve the connection of adults (age 18 and over) living with HIV to care in the community. The researchers will retrospectively look at the aggregate-level de-identified data of roughly 3,000 individuals admitted to the DC DOC over a 6-month period to determine the most effective HIV diagnostic test for routine opt-out testing in the correctional setting. Over the course of these 6 months, the correctional facility will transition from using POC only to POC + antigen/antibody (Ag/Ab), to solely using Ag/Ab, each for a 2-month duration. Individuals from this time period who are identified by corrections staff as HIV-positive either through testing upon admission, their electronic medical record (EMR) or self-report, and have a known release date will be considered eligible for the follow-up study to assess if care coordination is effective in linking others with HIV leaving the DC DOC to care. This follow-up will enroll 100 of these individuals who have consented to participate following their release from the DC DOC, and will consist of a chart review of their DC DOC EMRs and those from their community healthcare provider for up to two years after their release.

NCT ID: NCT04295876 Completed - HIV/AIDS Clinical Trials

The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services

BRIDGES
Start date: December 19, 2019
Phase: N/A
Study type: Interventional

The BRIDGES Project seeks to test a program intended to help women living with HIV who face specific barriers due to culture, gender, violence, trauma, adverse mental health, and substance use to be able to better access HIV care. This program was created and tried with women living with HIV, as previously studies have indicated that women with these experiences are less likely to have stable HIV care. The BRIDGES Project will use Peer Navigators, who are other women living with HIV who have had similar experiences and have been successful in accessing care, to help other women living with HIV to access HIV care and stay in HIV care. The BRIDGES Project will also provide support to women through group sessions co-facilitated by a licensed clinical therapist and Peer Navigator. Through participation in BRIDGES, women will: (1) build skills to cope with HIV care and treatment barriers (e.g., violence, trauma, adverse mental health, substance use); (2) be connected to HIV treatment and other support services (e.g., domestic violence, mental health, substance use); and (3) learn interpersonal skills to connect with support (e.g., service providers, peers, friends, family) when faced with new or ongoing barriers.