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HIV Infections clinical trials

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NCT ID: NCT05472051 Completed - HIV Infections Clinical Trials

Health and Migration Trajectories of Housekeepers in Bamako

2DM2K
Start date: February 28, 2022
Phase:
Study type: Observational

In Mali, migration from rural zones is a cultural phenomenon existing since 1970. During the dry season (9 months), an important number of young women leave their villages and migrate towards urban zones to seek for a job. In Bamako, the estimated number of housekeepers is 100 000 coming from rural regions and aged between 11 and 19 years. The current healthcare offer seems to be non-adapted to their particularities. This is a community-based research constructed on the basis of the activities of two NGOs in Mali: ADDAD (association for the defense of the rights of Housekeepers and domestic helpers ) and ARCAD Santé PLUS (the main NGO for healthcare access for HIV, hepatitis, and sexual health services). The research is conducted by the SanteRCom team in the UMR1252 SESSTIM research unit. The main objective of this observational study is to study the knowledge, beliefs, behaviors and practices in terms of health in general, and sexual health in particular; and to assess the acceptability of an offer of community-based prevention and health services provided by ARCAD Santé PLUS integrated in the activities of ADDAD. The integrating of community-based healthcare offer in a familiar and reassuring framework, such as that of ADDAD, should promote access to health services among housekeepers. The research is organized in 3 stages: 1. Preliminary qualitative survey based on focus group discussions. Allowing the identification of the housekeepers' needs in terms of prevention and healthcare services; and the behavioral particularities of the housekeepers community. It is planned to conduct 7 focus groups including between 42 and 56 housekeepers. 2. Communication and awareness campaigns in the regions of origin of housekeepers. Campaigns will be constructed on the basis of the results obtained from the preliminary qualitative survey. 3. Communication and awareness campaigns in Bamako; community-based activities for housekeepers will be organized 3 times per week during 5 months by the NGO ADDAD. Activities will include the community-based offer of prevention and healthcare services provided by the NGO ARCAD Santé PLUS, i.e. the novelty in the ADDAD's activities. A quantitative and qualitative surveys will be conducted over 5 months with participants recruited during the community-based activities. It is expected to enroll at least 1134 housekeepers, and to conduct a maximum of 25 individual interviews with selected housekeepers.

NCT ID: NCT05463783 Recruiting - Obesity Clinical Trials

Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain

Start date: March 14, 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05458102 Terminated - Clinical trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels

Start date: August 19, 2022
Phase: Phase 1
Study type: Interventional

The goal of this clinical study is to learn more about the impact of cobicistat (COBI) (P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and strong cytochrome P450 enzyme [CYP]3A inhibitor), voriconazole (VOR) (strong CYP3A inhibitor), and rifabutin (RFB) (moderate CYP3A inducer) on the study drug, vesatolimod (VES), in people with HIV-1 on antiretroviral therapy (ART).

NCT ID: NCT05457530 Withdrawn - Obesity Clinical Trials

Doravirine and Weight Gain in Antiretroviral Naive

DAWN
Start date: August 1, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.

NCT ID: NCT05454514 Completed - HIV Infections Clinical Trials

Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS

Start date: September 9, 2021
Phase: N/A
Study type: Interventional

This is a 90-day medication adherence study testing the HiDO is an automated AI-driven direct observation medication adherence platform, which is a 510K-exempt, Class I medical device with 24 people with HIV/AIDS, ages 18 to 55, who are currently taking ART and reporting less than 100% adherence. The aims of the study are to see whether the device can achieve >95% ART adherence among all participants averaged over 90 days and to perform usability testing using the System Usability Scale and Net Promoter scores.

NCT ID: NCT05452616 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis

SaDAPT
Start date: October 19, 2022
Phase: N/A
Study type: Interventional

SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL <400 copies/mL) 26 weeks after enrolment.

NCT ID: NCT05452564 Recruiting - Clinical trials for Human Immunodeficiency Virus

Baricitinib for Reduction of HIV - CNS

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

There is still no cure for the human immunodeficiency virus (HIV). While combination antiretroviral therapy (cART) is effective in decreasing deaths from HIV, infected individuals face a lifetime of treatment and many potential complications including end organ diseases such as HIV-associated neurocognitive disorders. HIV infection is controllable with antiretroviral therapy (ART), but ART cannot eliminate HIV reservoirs. Thus, there is no available cure for HIV. There is a large and growing body of evidence that the central nervous system (CNS) is an HIV reservoir site and a barrier to HIV eradication. Our group has done extensive pre-clinical work with janus-kinase (JAK 1/2) inhibitors. This includes baricitinib, which is an orally available, FDA-approved drug for rheumatoid arthritis. Evidence suggests that this drug has activity against HIV in the central nervous system (CNS). In our recently completed pilot study, we showed that baricitinib crosses the blood brain barrier (BBB) and decreases HIV CNS persistence in the brain. Using bloodwork, neurocognitive testing, MRIs and lumbar punctures, we plan to evaluate the change in central nervous system HIV after treatment with baricitinib versus placebo. We will also evaluate changes in neuroimaging, inflammation in blood and cerebrospinal fluid (CSF), and neuropsychological performance after treatment with baricitinib versus placebo. Evidence shows that the central nervous system is one of the reservoir sites that enables the HIV virus to persist in the body even after years of treatment. In order to attack this reservoir and eventually find a cure, it is vital to learn if certain medications can suppress HIV in the CNS.

NCT ID: NCT05450770 Not yet recruiting - HIV Infections Clinical Trials

Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination

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

ANRS 0146s NovaaTen study aims to determine the vaccine responses in the participants of the ANRS EP46 Novaa trial 10 years after a primary anti-yellow fever vaccination

NCT ID: NCT05446064 Recruiting - HIV Infections Clinical Trials

Buddhism Beliefs and HIV Stigma in Thailand

Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Thailand remains one of the countries with the largest population of people living with HIV (PLWH). It is estimated that 30 Thai provinces account for 75% of the HIV infections in that country, with ChiangMai as the most prevalent province in northern Thailand. Also, HIV/AIDS remains among the top 10 most common causes of death in Thailand. This high mortality rate may be partially explained by the notable HIV treatment cascade in Thailand: Among all the Thai PLWH, only 74% were retained in care, while 68% received ART, and roughly 50% reached viral suppression. An important reason for this is that HIV-related stigma still poses significant barriers for Thai PLWH to access healthcare and carry out health-protective behaviors, including adherence to medication schedules, to manage their HIV. In Thailand, substance use, including use of tobacco, alcohol, and other emerging recreational drugs, is a pressing health concern. In the HIV+ population in Thailand, it was found that 15% use tobacco, 70% use alcohol, and 2% use recreational drugs. In addition, among Thai HIV+ alcohol drinkers, about 13%-22% were heavy drinkers and 40% had sex under the influence of alcohol. Although the literature evaluating prevalence of substance use among Thai HIV+ individuals is emerging, the knowledge remains very limited regarding their risk and protective factors for substance use. Self-management interventions, typically include training modules for symptom management skills and coping strategies. In Buddhist-Thai culture, the goal of self-management may become assisting PLWH to find the peace and harmony within themselves by gradually "letting go" of those strong desires for certain materials or status that contribute to the uncertainty in lives. Therefore, this project aims to further the investigator's knowledge about self-management behaviors in HIV+ substance users in the context of Buddhist-Thai culture. The investigator aims to: 1. Explore how PLWH experience and interpret substance use, mental health, and self-management and identify key social-cultural factors that influence these factors. 2. Test the associations among mental health, substance use, self-management, health outcomes and selected key social-cultural factors among PLWH using a partial correlation network model. The results will be used for development of a culturally tailored, evidence-based self-management intervention to promote better health outcomes among Thai PLWH.

NCT ID: NCT05435027 Completed - COVID-19 Clinical Trials

Study of Self-Amplifying Messenger Ribonucleic Acid (samRNA) Vaccines Against COVID-19 in Healthy Adults and People Living With Human Immunodeficiency Virus (HIV)

Start date: February 28, 2022
Phase: Phase 1
Study type: Interventional

The primary objective is to assess the safety and tolerability of samRNA vaccines GRT-R912, GRT-R914, and GRT-R918 when administered as prime and/or boost in healthy adult participants naïve to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), SARS-CoV-2 convalescent, previously vaccinated, or non-vaccinated participants, and people living with HIV (PLWH) or HIV-negative.