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HIV-1 Infection clinical trials

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NCT ID: NCT06358885 Not yet recruiting - HIV-1-infection Clinical Trials

IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention

EBAI
Start date: April 2024
Phase: N/A
Study type: Interventional

This study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning (EBAI) to address their own alcohol-related attitudes and behaviors. Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI.

NCT ID: NCT06337032 Not yet recruiting - HIV-1-infection Clinical Trials

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

Start date: September 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events. The primary objectives of this study are as follows: - To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment. - To evaluate the safety of the study drug(s) in participants with HIV-1.

NCT ID: NCT06336434 Not yet recruiting - Pregnancy Clinical Trials

CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

Start date: September 24, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

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 with HIV-1 viral suppression and their infants.

NCT ID: NCT06333808 Not yet recruiting - HIV-1-infection Clinical Trials

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

ARTISTRY-2
Start date: March 2024
Phase: Phase 3
Study type: Interventional

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) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.

NCT ID: NCT06282783 Not yet recruiting - HIV Infections Clinical Trials

Studying Topiramate for Re-Activating the HIV-1 Reservoir

STAR
Start date: September 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Even with current HIV treatments, HIV is still a lifelong disease because it hides in some long-lasting cells in the body. One of the strategies to find a cure for HIV works by finding the virus in these cells, making it visible, and then getting rid of it. This is called the 'shock and kill' approach. So far, the drugs tested can find the virus, but they don't get rid of it completely. That's why there need to be new drugs that can do this more effectively. The Erasmus MC HIV Eradication Group (EHEG) has been testing new drugs in the lab and found a drug called topiramate can wake up the virus without harming the cells. The aim of this study is to test topiramate in people living with HIV. Most of the people that participate in HIV cure studies are men, even though most people living with HIV around the world are women. Previous research has shown that men and women might respond differently to these treatments. So, in this study, topiramate will be investigated in both men and women. This could help us find a cure that works for everyone.

NCT ID: NCT06247527 Not yet recruiting - Trauma Clinical Trials

Psychoeducation, Relaxation, PrOblem Solving, Activation, Cognitive Coping Therapy for Adolescents and Youth in HIV Care

PROACT
Start date: May 2024
Phase: N/A
Study type: Interventional

The proposed PROACT study will test the effectiveness of a mental health intervention (psychotherapy) for multiple common mental health conditions (depressive, anxiety and trauma symptoms) among adolescents and youth with HIV in Kenya. The study will also evaluate key factors for successful intervention implementation and conduct an economic evaluation to inform future intervention scale-up.

NCT ID: NCT06205602 Not yet recruiting - HIV-1-infection Clinical Trials

Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa

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

For people living with HIV, antiretroviral therapy (ART) helps to stop the virus from multiplying. The goal of current HIV treatment is to have such a small amount of the virus in the blood that it does not show up on regular tests. HIV is also hidden in cells throughout the body and can start multiplying when ART is stopped. This research study will test two new study drugs: 10-1074-LS and 3BNC117-LS. Both of these study drugs are antibodies against HIV. An antibody is generally a substance that the body makes in response to an infection. The antibodies being used in this study were made in a laboratory and were designed to attach to HIV and can block HIV from attacking cells in the body and from spreading to other parts of the body. These antibodies are being developed to potentially treat and prevent HIV. The main purpose of this study is to see if the study drugs affect the level of HIV that remains in the blood cells while taking ART and the level of HIV in the blood after discontinuing taking ART. The study will also see if it is safe to give people these antibodies and if they cause any side effects.

NCT ID: NCT06203132 Not yet recruiting - HIV-1-infection Clinical Trials

DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

ELDORADO
Start date: April 2024
Phase: Phase 3
Study type: Interventional

Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.

NCT ID: NCT06185452 Recruiting - HIV-1 Infection Clinical Trials

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

HOLA
Start date: September 26, 2023
Phase: Phase 4
Study type: Interventional

HOLA is a prospective, randomized (1:1), hybrid type (implementation-effectiveness), phase IV, double arm, open label, multicentric study including virologically suppressed HIVinfected subjects who start or are currently under treatment with the LA antiretroviral combination CAB+RPV, to evaluate the out-of-hospital administration of this combination in terms of acceptability, appropriateness, feasibility and satisfaction.

NCT ID: NCT06127290 Recruiting - HIV-1-infection Clinical Trials

HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia

Start date: December 1, 2021
Phase:
Study type: Observational

Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced.