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HIV clinical trials

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NCT ID: NCT05064956 Completed - Hiv Clinical Trials

Ad26.ZEBOV Booster in HIV+ Adults Previously Vaccinated With Ad26.ZEBOV/MVA-BN-Filo (EBOVAC HIV+ Booster Study)

Start date: October 6, 2021
Phase: Phase 2
Study type: Interventional

This is an open label study to evaluate the safety and immune response to a booster dose of Ad26.ZEBOV Ebola vaccine in HIV+ adults from Kenya and Uganda. Only participants who have received the 2-dose Ebola vaccine regimen "Ad26.ZEBOV/MVA-BN-Filo " in the VAC52150EBL2002 vaccine trial about 4 years ago are eligible to take part. Approximately 50 healthy HIV+ adults, aged 18 - 50 years at the time of the parent trial, will be invited. Participants will first be asked to provide consent to participate in this study. Upon receiving the booster vaccination, participants will be followed up for approximately 28 days (+/- 3 days) to collect information on side effects and provide blood samples for antibody measurement. This study is designed to provide descriptive information regarding vaccine safety and immunogenicity. There is no formal treatment comparisons and no formal testing of statistical hypothesis.

NCT ID: NCT05022407 Completed - Covid19 Clinical Trials

COVID-19 and HIV in Health Workers in Mozambique

COVIV
Start date: July 15, 2021
Phase:
Study type: Observational

While COVID-19 (coronavirus disease 2019) is an important emergent issue for all in the country, there is a significant number of people in the population who are especially vulnerable to the potential impact that the novel coronavirus epidemic may have on their health. The overall purpose of the study is to investigate: (1) the dynamics of COVID-19 infection among people living with HIV and health care workers providing HIV services; (2) the provision of HIV and HIV/TB care and treatment services at health facilities, within the scope of COVID-19 or in the context of COVID-19 and; (3) the perceptions of COVID-19 and access to care among people living with HIV and health care workers providing HIV services.

NCT ID: NCT05006625 Completed - Depression Clinical Trials

Implementation of a Collaborative Care Model to Manage Depression Among Adolescents and Young Adults in HIV Services in Thailand

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

This study aims to investigate the acceptability and feasibility of the implementation of a collaborative care model (CCM) to screen and treat depression. This model will includes cognitive behavioral therapy (CBT) and useof a task-shifting model to address depression among adolescents and young adults (AYA) who are seeking HIV treatment and prevention services at a hospital in Bangkok, Thailand. Analyses will be guided by the consolidated framework for implementation research (CFIR), which will include the identification of facilitators and barriers to implementation of this CCM. In the last 3 years, 10-20% of AYA patients at King Chulalongkorn Memorial Hospital (KCMH) who seek HIV treatment or prevention services suffer from mental health disorders. As a result, CCM integration for depression screening and treatment was implemented at the 'CU Buddy Clinic' KCMH with the ultimate goal of increasing access to and engagement in mental healthcare with a goal to improve the overall quality of life for Thai AYA. This project will inform a future implementation science study that will focus on how the optimization of integrated mental healthcare into routine AYA HIV treatment and prevention services can impact health outcomes for patients, including ART adherence and long-term viral suppression (AYA living with HIV) and HIV acquisition risk behaviors and PrEP adherence (AYA at risk for HIV).

NCT ID: NCT05006391 Completed - Hiv Clinical Trials

Tele-Coaching Community-Based Exercise (CBE) Study

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The primary aim of this research is to evaluate the implementation of an online tele-coaching community-based exercise (CBE) intervention with adults living with HIV.

NCT ID: NCT05005130 Completed - HIV Clinical Trials

Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia

TASKPEN
Start date: September 20, 2021
Phase: N/A
Study type: Interventional

This mixed-methods formative research study aims to adapt the WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public health system, and pilot test an adapted, streamlined, and task-shifted package of integrated HIV Noncommunicable Disease (NCD) services, collectively called "TASKPEN".

NCT ID: NCT04958889 Completed - HIV Clinical Trials

COVID-19 Recovery Study: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV

Start date: June 11, 2021
Phase:
Study type: Observational

This observational study will prospectively characterize the long-term symptoms and side effects of COVID-19 in cohorts of people living with and without HIV. This will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in health, and up to two blood draws from home through the use of a mobile phlebotomy service.

NCT ID: NCT04952766 Completed - Cancer Clinical Trials

Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults

EREVA
Start date: March 26, 2021
Phase: Phase 4
Study type: Interventional

The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Secondary objectives are to evaluate the humoral response in the nasal mucosa, and the capacity of antibodies to neutralize emerging variants of concerns and to prevent COVID-19.

NCT ID: NCT04937881 Completed - Hiv Clinical Trials

PK of TAF and TDF for PrEP in Pregnant and Postpartum Women

PrEP-PP PK
Start date: June 13, 2022
Phase: Phase 3
Study type: Interventional

This study will establish benchmarks of TFV-DP concentrations as measures of adherence following daily dosing with Tenofovir Alafenamide (TAF) compared with Tenofovir Disoproxil Fumarate (TDF) during pregnancy and postpartum. Study Investigators will recruit from an ongoing observational cohort study in Cape Town, South Africa, PrEP-PP (recruitment ongoing through July, 2021; NIMH R01MH116771; PI Coates & Myer). Findings form this PK sub-study will be used to inform future PrEP in pregnancy and postpartum studies and develop benchmarks of the relative PK between TDF and TAF.

NCT ID: NCT04936594 Completed - HIV Clinical Trials

TMS for Smoking Cessation in PLWHA Cessation in People Living With HIV/AIDS (PLWHA)

Start date: May 24, 2021
Phase: N/A
Study type: Interventional

The pilot study proposal aims to modulate craving and attentional bias towards smoking cues in 40 people living with HIV/AIDS (PLWHA) using transcranial magnetic stimulation (TMS), with functional MRI (fMRI) brain correlates. TMS is a form of noninvasive brain stimulation and modulates neural activity using tiny doses of focused electricity. For the study, participants would perform two cognitive tasks and neuroimaging before and after the TMS and investigators would compare changes in these paradigms with TMS. The investigators will also get a point of contact urine drug screen before study initiation. The investigators will aim to recruit 20 subjects in each arm of our trial (total of 40) from the BlueGrass HIV Clinic.

NCT ID: NCT04904406 Completed - HIV Infections Clinical Trials

Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals

AVERTAS
Start date: October 22, 2020
Phase: Phase 4
Study type: Interventional

Randomized controlled parallel open-label study in people living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion. Participants (n=95) are randomized to continue 3 drug-regimen dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention). Follow-up is 48 weeks. Data is collected at baseline and week 48. Primary outcome is changes in weight from baseline of more than 2 kg. Secondary outcomes are changes in cardiac risk, composition and calcification of the heart tissue, and changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is applied to focus on the cardiac adverse effects of abacavir.