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NCT ID: NCT06064591 Recruiting - Severe Malaria Clinical Trials

Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX

IMMETASEX
Start date: December 13, 2023
Phase:
Study type: Observational [Patient Registry]

Understanding the sexual conversion of the malaria parasite is essential to interrupt malaria transmission. A new tool is developed that, based on expression analysis of sexual stage biomarkers, will estimate sexual conversion rates in natural infections.

NCT ID: NCT06062238 Recruiting - Tuberculosis Clinical Trials

Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults

Start date: March 5, 2024
Phase: Phase 3
Study type: Interventional

The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA-Negative Cohort and Human Immunodeficiency virus (HIV) Cohort.

NCT ID: NCT05989802 Recruiting - Tuberculosis Clinical Trials

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years. The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies seek to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests for use in children.

NCT ID: NCT05938621 Recruiting - Hiv Clinical Trials

Estamos Juntos (We Are Together): Improving HIV Care Delivery by Capacitating Health Care Providers

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Health care workers' negative behavior towards patients (likely a reflection of low job satisfaction, frustration with delivering HIV care and treatment in extremely resource-limited settings, and burnout) is one of the primary reasons people living with HIV abandon treatment in Mozambique. The purpose of this proposal is to test the impact and implementation of a provider resilience intervention and an anti-stigma intervention, individually and in combination, using a randomized controlled trial design at four health facilities. This potentially high-impact intervention offers the opportunity to test a low-cost, provider-focused approach to improving HIV treatment that, if proven effective at increasing adherence and retention in care, could be tested in a fully powered R01 trial in Mozambique.

NCT ID: NCT05858151 Recruiting - ASF Consumption Clinical Trials

Transforming Food System Evaluation in Mozambique

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

Global Alliance for Improved Nutrition (GAIN)'s "Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable" program seeks to improve consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different targeted foods in 4 countries by operating at multiple levels - individuals, households, markets, producers, and policies. RTI and local partners propose to conduct impact and process evaluations of GAIN's program tailored to the theory of change and the target foods for Mozambique. The evaluation in Mozambique will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) implementation research framework.

NCT ID: NCT05807399 Recruiting - Clinical trials for Pulmonary Tuberculosis

PanACEA - STEP2C -01

Start date: April 14, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2B/C, open label platform study that will compare the efficacy, safety of 3 experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.

NCT ID: NCT05689047 Recruiting - Acute Malaria Clinical Trials

Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

Start date: March 29, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria. Pyramax (Artesunate/Pyronaridine) will act as an internal control providing reference safety data and a benchmark for the efficacy evaluation.

NCT ID: NCT05686356 Recruiting - Tuberculosis Clinical Trials

A Pan-TB Regimen Targeting Host and Microbe

panTB-HM
Start date: July 28, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This project will develop the first regimen meeting WHO criteria for a pan-TB indication, ie, not requiring knowledge of RIF susceptibility. The regimen will test sutezolid at 2 dose levels, with the approved anti-TB drugs bedaquiline and pretomanid, in a phase 2c trial. It will also test whether the addition of N-acetylcysteine (NAC), a re-purposed host-directed WHO essential medicine, can protect the lung and liver against oxidative damage, preserve lung function, and accelerate the eradication of MTB infection by replenishing glutathione (GSH).

NCT ID: NCT05590455 Recruiting - HIV I Infection Clinical Trials

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

TIMPANI
Start date: April 11, 2023
Phase: Phase 2
Study type: Interventional

Randomized phase II clinical trial which aims to assess the impact on 3-month mortality and safety of adding adalimumab to standard treatment (anti-tuberculosis drugs and corticosteroids) in HIV patients with tuberculosis meningitis in 3 countries (Brazil, Mozambique, and Zambia).

NCT ID: NCT05580666 Recruiting - Clinical trials for HIV Disease Progression

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

REVIVE
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.