View clinical trials related to HIV/AIDS.
Filter by:Background: In children and adults living with HIV, cardiomyopathy is a major source of comorbidity. Traditional echocardiographic measures are insensitive and consequently cardiomyopathy often goes undiagnosed until late stages of disease. Myocardial deformation imaging represents a promising means to identify early dysfunction, but to date there have been no large studies using strain or strain rate to assess cardiac function in children with HIV and to establish predictors of worse cardiac function such as viral burden and ART regimen. These studies are critically important as earlier diagnosis and intervention represent the best means to alter the course of HIV-associated cardiomyopathy. Objectives: To determine the association of biomarker levels, myocardial deformation, and viral load level history in HIV infected children attending Moi Teaching and Referral Hospital (MTRH) clinic. Design: A cross-sectional study on clients attending HIV clinic, MTRH. Setting: Module 4 HIV clinic at MTRH in western Kenya, Africa. Population: HIV-infected children attending clinic in 2017 - 2018 Main Measures: Echocardiographic function assessment, Age, Immune status, other illnesses, ART status. Conclusions: The study will explore the NIH/HIV High Priority Target area of HIV-associated cardiac co-morbidities and will enhance understanding of the relationship between cardiac function and viremia. The investigators expect to be able to reliably define a subset of children with worse cardiac function by risk factors: specific ART regimens, less time virally suppressed, and increased BNP biomarker.
Purpose: Perform a 3-phase (single dose, multi dose, dose proportionality) study in healthy volunteers using daily tenofovir+emtricitabine, dolutegravir, and maraviroc dosing to quantify intra- and inter-subject variability and dose proportionality. The influence of covariates on ARV hair distribution (e.g., hair growth rate, race, hair color, hair treatment) will also be measured. Using both population PK modeling and physiologic based PK (PBPK) approaches, a statistical model to quantify ARV adherence patterns based on signal intensity/pattern will be developed. Participants: Healthy volunteers, aged 18 to 70 years of age, inclusive on the date of screening, with an intact gastrointestinal system and at least 1cm caput hair. Procedures (methods): Participants will be sequentially assigned to enroll in a dosing arm, beginning with maraviroc (MVC), then dolutegravir (DTG), and ending with tenofovir/emtricitabine (TFV/FTC). All participants will take a single observed dose of study product in Phase 1, with blood and hair samples obtained on Days 3, 7, 14, 21 and 28 days post-dose. In Phase 2, all participants take 28 days straight of daily dosing, observed, of the same study product. Blood and hair samples obtained on the same days post-dose. In Phase 3, participants will be randomized to stop their drug, or decrease dosing to one or three doses weekly. Hair and blood samples will again be obtained on the same days post-dose. All participants will complete a follow-up safety visit with 14 days of completing study sampling.
Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.
The mass provision of HIV treatment in rural KwaZulu-Natal, South Africa has raised adult life expectancy by 18 years since 2003. We will conduct a population-based survey to assess young adults' beliefs about HIV, HIV treatment, and expectations for the future in the era of mass HIV treatment. Thh investigators will conduct a randomized evaluation to assess whether a short video providing young adults with information on longevity gains from HIV treatment affects young adults survival expectations, hope for the future, and health and educational behaviours, including uptake of HIV testing, the study's primary outcome.
The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.
This study will ask Thai MSM and transgender women (TG) participants to self-select to participate in one of the 3 different study groups which provide various degrees of integrated online interventions and offline interventions for the Recruit-Test-Treat-Retain for HIV prevention and care among 3 groups (A, B1 and B2). All participants will be followed up either offline or online for 12 months. HIV-negative participants will be scheduled for repeat HTC at months 6 and 12. HIV-positive participants will be scheduled either offline or online to review their treatment history at months 6 and 12. HIV-negative participants in Group B1 and B2 can choose again at months 6 and 12 to switch from the online to offline, and vice versa, at the HIV testing/post-test counseling step and the referral to HIV treatment step
This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and FTC in healthy women comparing the drug levels and activity in the absence (first phase) and then the presence (second phase) of DMPA. The investigators will recruit 12 healthy women aged 18-45 who are HIV-negative and at low risk for acquiring HIV.
UCSF and Project Open Hand (POH), a community based organization in San Francisco which provides meals and groceries to chronically ill clients in the Bay Area, have partnered to conduct an initial randomized controlled trial (RCT) of the Changing Health through Food Support (CHEFS) pilot intervention implemented by POH. The intervention consists of providing comprehensive, medically-appropriate food support, individual nutritional counseling, and group-based nutritional education over 6 months to low-income clients who have been diagnosed with HIV in order to improve their viral load and health-related quality of life (primary outcomes) as well as depression, ART adherence, food security and diet quality (secondary outcomes). We will randomize 200 participants to the intervention (n=100) or control (n=100). Participants will be followed for 6 months. The investigators will assess outcomes at baseline and 6-month follow-up using a quantitative survey and blood draws. In addition, the investigators will conduct a qualitative study at follow-up in a subset of participants to understand perceived impacts, barriers and facilitators.
TB is increasingly diagnosed using the GeneXpert platform, which can be used for a variety of tests (not just TB). HIV viral load monitoring is required at least annually in patients on ART to detect failure of virologic suppression, however, most HIV VL testing is done centrally. A patient with virologic failure is more likely to get TB. The investigators wish to see if Xpert done at the clinic results in faster patient TB diagnosis and treatment initiation compared to sending specimens away for central testing. In a different patient group (PLHIV returning for HIV treatment monitoring), the investigators wish to see if POC Xpert HIV-1 viral load (Xpert VL) testing results in faster patient viral load quantification compared to centralised testing. Both POC tests will use the same testing hardware. This polyvalent utility of the GeneXpert system is hitherto uninvestigated in this local setting. Newly diagnosed pre-ART HIV positive patients will be approached and asked to be a part of this study. Patients will be randomly assigned to Ultra done at the clinic or the normal off-site laboratory TB testing. The time taken for patients to get diagnosed and time-to-treatment will be recorded. We will also do exploratory diagnostic accuracy evaluations including but not limited to, Ultra when done on mouth samples, the new SILVAMP FujiLAM on urine, and host RNA blood signatures for active TB. Additionally, a different group of HIV positive patients (on ART) returning to the clinic for annual follow-up visits will also be asked to join the study. These patients will be randomly selected for either Xpert VL testing done at the clinic or the normal off-site testing. The time taken for patients to receive viral load results will be recorded. Should the patient's viral loads be found to be higher than anticipated and considered by the clinical to indicate a lack of viral suppression, the time taken for patients to have ART regimen adjusted, receive adherence counselling or received HIV drug susceptibility testing will be recorded. This project will confirm if Ultra TB testing performs well in PLHIV irrespective of symptoms and may produce evidence that supports universal TB testing in this important and vulnerable patient group, including using novel diagnostics on non-traditional specimen types. The investigators will also assess whether POC placement of Ultra and Xpert VL has benefits (e.g., more patients diagnosed for TB or VL monitored during the same day visit).
GPS is a sexual health promotion and HIV prevention peer-delivered counselling program. The GPS program has 4 parts: information provision about HIV and sexually transmitted infections, motivational interviewing counselling, sexual health behavioural skills building, and linkage to care. The adaptation grant has three goals: 1) to establish a multi-region and multi-sectoral team that can deliver the revised program across a variety of settings, 2) to learn how best to deliver this program as individual counselling program and also how to adapt this program for HIV-negative MSM, and 3) to pilot the individual program in 5 settings across Ontario and British Columbia. The research team will evaluate the pilot adaptation through mixed methods, employing a quantitative questionnaire and one-on-one semi-structured interviews.