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NCT ID: NCT05502692 Completed - Dolutegravir Clinical Trials

CHARACTERISE - A Cross-sectional, Observational Study to Characterise the Transition to Dolutegravir-based Regimens in South Africa in Terms of the Emergence of Obesity, Viral Re-suppression and Integration Into Routine Programme Care

CHARACTERISE
Start date: July 12, 2022
Phase:
Study type: Observational [Patient Registry]

The ADVANCE clinical trial compared three recommended first-line regimens two containing dolutegravir head-to-head and demonstrated virological non-inferiority at 48- and 96-weeks respectively1,2, paving the way for the mass- introduction of dolutegravir-containing regimens across low- and- middle-income countries. The dolutegravir-containing regimens in ADVANCE were very well tolerated and demonstrated remarkable viral re-suppression in patients with viraemia when adherence measures were instituted, even in the presence of genotypically-documented resistance1,2. Across Africa, including South Africa, and in many other low- and middle-income countries, the combination of tenofovir disoproxil fumarate/lamivudine (or emtricitabine) /dolutegravir has been rolled out to millions of patients, much of this with Unitaid support to research, programmes and communities. Most ADVANCE patients have since transitioned out of the study and are on tenofovir disoproxil fumarate/lamivudine/dolutegravir in South African public sector clinics in central Johannesburg. One of the unanticipated findings of ADVANCE and the concomitant Unitaid-supported NAMSAL3 study in Cameroon, as well as analyses of registration studies and observational studies, was the consistent finding that patients on dolutegravir experience significant weight gain and new-onset obesity. It remains unclear whether this is a feature of the integrase inhibitor class (and aggravated by tenofovir alafenamide), or whether other factors are at play - it is possible that HIV infection itself may predispose to weight gain in successfully treated patients, and other antiretrovirals may alter weight trajectories. The signal has been met with alarm by the public health community, as many countries where TLD is being rolled out are experiencing a parallel obesity epidemic. Obesity is strongly associated with adverse outcomes, including diabetes, cardio-vascular-disease (CVD), sleep apnoea, gastrointestinal and muscular-skeletal disorders, asthma, poor pregnancy outcomes, many cancers, mental health issues, and poor COVID-19 outcomes. In many countries with large antiretroviral programmes, these concurrent epidemics have significant public health and financial implications, and clarification of the extent of the obesity signal is urgent.

NCT ID: NCT05495503 Completed - Clinical trials for Post-inflammatory Hyperpigmentation

Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Post-inflamamatory Hyperpigmentation (PIH).

Start date: October 18, 2022
Phase: N/A
Study type: Interventional

CS5_2 study aims to evaluate the tolerance of 4 different conditions of cryotherapy treatments applied on dorsal post-inflammatory hyperpigmentation (PIH) spots. This study is a proof of concept, designed to be interventional, monocentric, randomized and double blind. The study will evaluate 4 prototypes : (814A-v1), (814B-v1), (814C-v1) and (814D-v1).

NCT ID: NCT05494736 Completed - Clinical trials for Human Immunodeficiency Virus

MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)

Start date: November 17, 2022
Phase: Phase 1
Study type: Interventional

This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL.

NCT ID: NCT05491707 Completed - Anxiety Clinical Trials

Effect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia

Start date: January 4, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effect of listening to music, to a control group (no music), on peri-operative anxiety using the validated VAS-A, in patients undergoing lower limb arthroplasty procedures under spinal anaesthesia.

NCT ID: NCT05484947 Completed - Outcome, Fatal Clinical Trials

The HIV Testing Trends and Outcomes at a Johannesburg Trauma ICU Unit

Start date: January 1, 2017
Phase:
Study type: Observational

A retrospective observational study on the HIV testing trend and outcomes in a trauma population admitted to a critical care unit for care.

NCT ID: NCT05478252 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes

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

The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D). Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. Participants need to take one injection of semaglutide once a week, on the same day of every week. Participants will have a total of 11 clinic visits and the study will last for about 35 weeks (approximately 8 months).

NCT ID: NCT05438589 Completed - Clinical trials for COVID-19 Respiratory Infection

Novel Rapid POC Diagnostics for COVID-19

Start date: April 25, 2022
Phase:
Study type: Observational

This is a prospective, multicentre study in which the diagnostic accuracy of multiple Covid-19 Antigen rapid diagnostic tests will be assessed for COVID-19 case detection using prospectively collected nasal swabs and saliva samples from participants suspected to have Covid-19 infection (with or without symptoms). The study will last approximately 9 months.

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.

NCT ID: NCT05417620 Completed - HIV Infections Clinical Trials

Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (PrEP) use among young women and to influence community norms around PrEP in South Africa. To do this, the investigative team will analyze PrEP initiation and retention data from the study's implementing partner, TB HIV Care, a non-profit organization providing PrEP to marginalized young women in South Africa. The effect of the social media campaign and community engagement will be tested using a short duration cluster randomized trial (CRT).

NCT ID: NCT05414097 Completed - Cervical Cancer Clinical Trials

Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa

FIND
Start date: July 16, 2022
Phase:
Study type: Observational

The primary aim of the study explore drivers of cervical cancer screening and barriers contributing to low screening coverage among women in South Africa. Secondary aims are determining preferences for cervical cancer prevention services using a discrete choice experiment and developing a multi-level package of interventions that will address barriers to cervical cancer screening and improve engagement in care among women.