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NCT ID: NCT06316102 Active, not recruiting - HIV Clinical Trials

Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo

Start date: July 14, 2023
Phase: N/A
Study type: Interventional

This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors), including individual counseling, peer navigation, and community mobilization for transfeminine people living with HIV in the Dominican Republic using an iterative consultation process. Prior to this randomized controlled trial, feasibility and initial effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV (no control group) and documented positive trends in antiretroviral therapy use (70% to 85%, p=0.03), missed care appointments (35% to 20%, p=0.39) and antiretroviral therapy adherence (86% to 96%, p=0.50). Participants emphasized that trusting intervention staff and being treated with respect in individual sessions allowed them to improve self-esteem. Limited trust and cohesion among trans women, however, inhibited more extensive engagement with peer navigation and community activities. In response, the study team identified two key modifications to strengthen and further tailor the intervention for transfeminine people living with HIV: 1) integrate more gender affirming content, including with providers and 2) focus on building trust among transfeminine people through sequential implementation of individual and then community components. The purpose of the proposed study is to conduct a pilot randomized trial of the Gender-affirming Abriendo Puertas intervention. In Aim 1, the preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral suppression among transfeminine people randomized to the intervention compared to those randomized to control will be assessed. The research study will randomly assign transfeminine people living with HIV to the Gender-affirming Abriendo Puertas intervention (n=60) (individual counseling, peer navigation, provider training, and community support building) or control group (n=60). There will be baseline, 6, and 12-month surveys and viral load assessments to assess differences across study arms. In Aim 2, the study team will examine pathways of influence (e.g. decreased stigma, increased cohesion) and experiences with the intervention to identify specific areas for improvement and scale up. Longitudinal qualitative interviews will be conducted at baseline, 6, and 12 months with 20 intervention participants. Together with surveys, the study team will assess how Gender-affirming Abriendo Puertas participation affects pathways between stigma, cohesion, and HIV outcomes. The study team will also elicit experiences and recommendations from providers and intervention staff in focus groups at 6 (n=2) and 12 months (n=2).

NCT ID: NCT06251024 Recruiting - Healthy Volunteers Clinical Trials

Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

Start date: April 2, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV. The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.

NCT ID: NCT06106581 Recruiting - Clinical trials for Chikungunya Virus Infection

A Phase 2 Clinical Study of VLA1553 in Healthy Children Aged 1 to 11 Years

Start date: December 18, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, prospective, randomized, observer-blinded, three arm, phase 2 clinical trial evaluating the full dose formulation of VLA1553, half dose formulation of VLA1553 and control. At least 300 male and female healthy children aged 1 to 11 years will be enrolled and the overall distribution of participants will be 2:2:1 to the two VLA1553 dose groups (n=120 each) or control (n=60).

NCT ID: NCT06052059 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

NCT ID: NCT05875441 Recruiting - Scabies Clinical Trials

Efficacy and Safety Study of Moxidectin in Adults With Scabies

Start date: November 23, 2023
Phase: Phase 2
Study type: Interventional

Moxidectin is not approved to treat scabies in humans. The effective dose of moxidectin to treat scabies is not known. This study aims to assess the efficacy of a single administration of 8 mg, 16 mg, or 32 mg moxidectin per oral in achieving Scabies Complete Cure at Day 28. This study also aims to assess the safety of three strengths of single moxidectin doses in adults with scabies.

NCT ID: NCT05869435 Completed - Clinical trials for Chronic Total Occlusion of Arteries of the Extremities

FastWire REvascularisation of Extremities, (For LOWer Limbs) - Feasibility Study (FREEFLOW)

Start date: December 14, 2022
Phase: N/A
Study type: Interventional

This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)

NCT ID: NCT05705440 Recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control

Start date: February 7, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this follow-up study is to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study. The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905). No intervention will be administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the above-mentioned prior RSV MAT studies.

NCT ID: NCT05705349 Recruiting - HIV-1 Infection Clinical Trials

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Start date: March 8, 2023
Phase: Phase 3
Study type: Interventional

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

NCT ID: NCT05603845 Active, not recruiting - Severe Asthma Clinical Trials

Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients

iOUTRUN
Start date: February 20, 2023
Phase:
Study type: Observational

This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.

NCT ID: NCT05585307 Active, not recruiting - HIV-1-infection Clinical Trials

Study of Novel Antiretrovirals in Participants With HIV-1

Start date: October 26, 2022
Phase: Phase 1
Study type: Interventional

Master protocol: The goal of this master clinical trial study is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Substudy-01 (GS-US-544-5905-01) will evaluate bavtavirine in PWH. Substudy-02 (GS-US-544-5905-02) will evaluate GS-1720 in PWH. Substudy-03 (GS-US-544-5905-03) will evaluate GS-6212 in PWH.