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NCT ID: NCT05184452 Recruiting - HIV Infections Clinical Trials

A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

Start date: November 15, 2021
Phase: Phase 1
Study type: Interventional

Part A: The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. The study will also look at whether the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part of the study is to understand how the body's immune system responds to lab-made antibodies against HIV when they are given in combination at different doses. The study also wants to see if the way the antibodies are given affects the immune response.

NCT ID: NCT05168813 Recruiting - HIV Infections Clinical Trials

Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.

NCT ID: NCT05154513 Recruiting - HIV Infection Clinical Trials

Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV

Start date: December 15, 2021
Study type: Observational

IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.

NCT ID: NCT05127070 Recruiting - Prematurity Clinical Trials

Evaluating the NeoTree in Malawi and Zimbabwe

Start date: October 1, 2019
Study type: Observational

Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor. Health systems strengthening through digitial quality improvement systems, such as the Neotree, are a potential solution. The overarching aim of this study is to complete the co-development of NeoTree-gamma with key functionalities configured, operationalised, tested and ready for large scale roll out across low resource settings. Specific study objectives are as follows: 1. To further develop and test the NeoTree at tertiary facilities in Malawi and Zimbabwe 2. To investigate HCPs and parent/carer view of the NeoTree, including how acceptable and usable HCWs find the app, and potential barriers and enablers to implementing/using it in practice. 3. To collect outcome data for newborns from representative sites where NeoTree is not implemented. 4. To test the clinical validity of key NeoTree diagnostic algorithms, e.g. neonatal sepsis and hypoxic ischaemic encephalopathy (HIE) against gold standard or best available standard diagnoses. 5. To add dashboards and data linkage to the functionality of the NeoTree 6. To develop and test proof of concept for communicating daily electronic medical records (EMR) using NeoTree 7. To initiate a multi-country network of newborn health care workers, policy makers and academics. 8. To estimate cost of implementing NeoTree at all sites and potential costs at scale

NCT ID: NCT05007821 Recruiting - Tuberculosis Clinical Trials

Linezolid Dosing Strategies in Drug-Resistant TB

Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug or treatment) of an anti-TB treatment regimen that compares two doses of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). This study will also measure the level of these medicines in the participants' blood.

NCT ID: NCT04874688 Active, not recruiting - Stunting Clinical Trials

Child Health, Agriculture and Integrated Nutrition

Start date: April 26, 2021
Phase: N/A
Study type: Interventional

CHAIN is an open-label, individually randomized trial of improved infant and young child feeding (IYCF) versus "IYCF-plus" among 192 infants enrolled between 5-6 months of age in Shurugwi district, rural Zimbabwe. Interventions comprise sequential behaviour-change interventions delivered by village health workers together with food supplements. In the IYCF arm, infants will receive white maize and small-quantity lipid-based nutrient supplement (SQ-LNS) daily from 6 months of age. In the IYCF-plus arm, infants will receive orange pro-vitamin A-biofortified maize, and SQ-LNS, plus powdered sugar beans, moringa and whole egg powder. The primary outcome will be the proportion of infants in each trial arm reaching daily energy requirements at 9 months of age (visit window 9-11 months of age). Secondary outcomes are other nutrient intake, anthropometry and haemoglobin. Tertiary outcomes are laboratory measures of microbiome composition, environmental enteric dysfunction, inflammation, innate immune function, circulating choline and essential amino acids, and urinary metabolic profile. Two qualitative substudies will explore i) the feasibility and acceptability of the IYCF-plus intervention; and ii) the influence of migration on household food consumption and production.

NCT ID: NCT04874675 Suspended - PAIN Clinical Trials

An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery

Start date: June 2021
Phase: N/A
Study type: Interventional

Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of Diclofenac/ acetaminophen/codeine and ibuprofen/acetaminophen/codeine .

NCT ID: NCT04860323 Recruiting - HIV Infection Clinical Trials

Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study

Start date: May 28, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if they get HIV. This study will evaluate the viral and immune system responses in an Analytical Treatment Interruption (ATI), in participants who received VRC01 or placebo and got HIV while enrolled in HVTN 703/HPTN 081 (NCT02568215). Participants in this study will stop taking their HIV medication. They will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is unable to control the HIV or they meet other ART re-start criteria as noted in section "Detailed Description". While they are not taking HIV medication, their HIV levels will be tested frequently, and their health will be monitored closely. This is called an analytical treatment interruption, or an ATI. An ATI is an experimental procedure that is only used in carefully monitored research.

NCT ID: NCT04824131 Active, not recruiting - HIV Infections Clinical Trials

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females - A Sub-study of HPTN 084

Start date: November 4, 2020
Phase: Phase 2
Study type: Interventional

This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.

NCT ID: NCT04782739 Recruiting - HIV Infections Clinical Trials

Evaluation of the Impact of the COVID-19 Pandemic on Provision and Uptake of Services for the Prevention of Mother-to-child Transmission of HIV and Syphilis in Zimbabwe

Start date: March 15, 2021
Study type: Observational

The COVID-19 pandemic and response are likely to lead to severe unintended consequences for the prevention of mother-to-child transmission (PMTCT) of HIV and syphilis. Zimbabwe has made huge progress in coverage of antenatal testing of HIV and syphilis, which reached 98% and 91% in 2019, and is aiming for dual elimination. However, there is emerging evidence of disruption to health services due to COVID-19, similar to that seen in prior epidemics, which may reverse this progress. Mathematical modelling has estimated 3 and 6 month interruptions to ART supply would lead to 1.67 and 2.07 times more babies being born with HIV in SSA over the next year respectively. This study aims to provide real-world data to understand the effects of COVID-19 on the provision and uptake of PMTCT services. Our study has five objectives. Firstly, to conduct a retrospective analysis of national data routinely collected by healthcare facilities to explore changes before, during and after the pandemic in key indicators related to antenatal testing and treatment of HIV and syphilis, and management of HIV-exposed and infected infants. Secondly, data on neonates admitted to Sally Mugabe Central Hospital, already collected for the NeoTree study, will be analysed to explore the impact of COVID-19 on the number of HIV-exposed infants hospitalised, their clinical status at presentation and outcomes. Thirdly, qualitative studies with mothers and healthcare workers will explore barriers to optimal engagement with care and provision of PMTCT services respectively. Fourthly, quantitative results on testing and ART provision will be used to model the impact of disruptions on the rate of PMTCT of HIV enabling policy makers to plan for subsequent waves of COVID-19 and future epidemics. Finally, educational materials will be developed, piloted and disseminated during the project to provide information to pregnant women on safe access to PMTCT services.