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Histoplasmosis clinical trials

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NCT ID: NCT05814432 Not yet recruiting - Immunosuppression Clinical Trials

Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS

Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

Phase III trial evaluating the safety and efficacy of a single high dose (10 mg/kg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg/kg of liposomal amphotericin B for two weeks) (INDUCTION trial).

NCT ID: NCT05685641 Not yet recruiting - Clinical trials for Acquired Immunodeficiency Syndrome

Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City

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

In Mexico City, the main cause of mortality among people living with HIV (PLHIV) continues to be opportunistic infections (OIs). Early detection of OIs allows their timely treatment and improves their prognosis. The use of rapid diagnostic tests (RDT) based on antigens of the most frequent causative agents of OIs allows adequate screening of these patients and facilitates decision making at the point of care. Unfortunately, these studies are not widely available in the different PLHIV care centers in the CDMX. We will conduct an open-label, non-inferiority uncontrolled clinical trial to investigate the diagnostic performance of urinary lipoarabinomannan, urinary Histoplasma antigen and serum Cryptococcus antigen in patients presenting for care with advanced HIV in CDMX, supported by rapid cluster of differentiation 4 (CD4) testing with lateral flow technology. Four referral hospitals will participate over 12 months. All patients with diagnosed HIV disease and suspected advanced disease presenting for care at participating centers will be included in the study. An inventory of approximately 1000 RDT will be obtained and distributed among the participating sites. A study coordinator will be hired and will visit each site once a week to collect the study variables and follow up on the included patients. The primary outcome of the study will be the percentage of patients with advanced disease who present with diagnoses made by RDT compared to historical controls of patients diagnosed with OI in 2022 at participating centers by conventional methods. Secondary outcomes will be time to initiation of antiretroviral therapy (ART), time to initiation of OI treatment, and 30-day mortality after HIV diagnosis.

NCT ID: NCT04059770 Completed - AIDS Clinical Trials

Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients

Start date: February 14, 2020
Phase: Phase 2
Study type: Interventional

Disseminated histoplasmosis (DH) is one of the major AIDS-defining infections responsible for high mortality rates in HIV-infected patients. Liposomal amphotericin B (L-AmB) is considered the therapy of choice for AIDS-associated histoplasmosis.However, many patients in Latin America are still treated with high doses of deoxycholate amphotericin B (d-AmB) for long periods. These regimens are associated with toxicity and thus reduced efficacy. Therefore, a better treatment strategy is necessary to improve the activity of this amphotericin B treatment. Treatment with a high dose of L-AmB for short periods (rather than standard doses for longer periods) is a promising approach considering that the antifungal effect of amphotericin B depends on peak concentrations. This randomized open-label Phase II study aims to determinate and to compare the activity and safety of three L-AmB regimens, as induction therapy for DH in AIDS patients.

NCT ID: NCT03059992 Completed - Clinical trials for Invasive Candidiasis

Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment

FURI
Start date: April 1, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.

NCT ID: NCT02911740 Withdrawn - HIV Clinical Trials

Additive Benefit of the Urine LAM Test to Current TB Diagnostics in HIV Positive Adults in Panama City, Panama

Start date: November 2017
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is one opportunistic infection often seen in HIV individuals. In 2013, there were an estimated 31,800 HIV-TB co-infection cases and 6,100 HIV-related deaths due to TB in the Americas. Due to the non-specific nature of its clinical symptoms, TB can be confused with various diseases such as histoplasmosis, sarcoidosis, lymphoma, and pneumonia. In Panama, where Histoplasma capsulatum is endemic, diagnosing TB versus histoplasmosis based on clinical symptoms can be difficult. In Panama, approximately 7.65% of HIV patients are co-infected with histoplasmosis, and there is a 30% mortality rate in HIV-histoplasmosis patients in Latin America. Due to similar clinical features, misdiagnosis of active TB and disseminated histoplasmosis in endemic regions may lead to incorrect antibiotic management, which in turn results in unnecessary toxicity, antibiotic resistance, and monetary expenditures. The investigators interests lie in increasing TB diagnostic accuracy using a simple urine dipstick test and evaluating physician response to new diagnostic testing, in order to reduce misdiagnosis and improve health outcomes in the HIV population.

NCT ID: NCT02493738 Completed - Candidiasis Clinical Trials

A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers

Start date: July 2015
Phase: Phase 1
Study type: Interventional

Study Objectives: - To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and fed condition in healthy male subjects - To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under fed condition in healthy male subjects - To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in Korean healthy male subjects

NCT ID: NCT01884779 Active, not recruiting - HIV Clinical Trials

Prevalence of Histoplasmosis in HIV + Patients With a Rapid Diagnostic Test in West Indies

EDIRAPHIS
Start date: August 2013
Phase: N/A
Study type: Observational [Patient Registry]

Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The diagnosis of this disease requires invasives procedures, laboratory performance, and delays up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and urine samples that looks interesting in endemic areas, particularly in developing countries. The study aims to measure the proportion of HIV-infected patients hospitalized or in outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum.

NCT ID: NCT01790893 Recruiting - Clinical trials for Ocular Histoplasmosis

Treatment for Presumed Ocular Histoplasmosis

HANDLE
Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.

NCT ID: NCT01578720 Completed - Clinical trials for Choroidal Neovascularization

Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

Start date: June 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).

NCT ID: NCT01256580 Withdrawn - Myopia Clinical Trials

Intravitreal Bevacizumab vs.Combination Therapy for CNV Due to Other Than AMD

CNV
Start date: August 2010
Phase: N/A
Study type: Interventional

Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV) due to other causes. The limitation of this type of treatment is the necessity for frequent intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy in combination with photodynamic therapy can reduce the number of treatments needed with monotherapy while achieving similar visual results. There are ongoing multicenter trials evaluating combination therapy in patients with wet AMD but no similar trial for patients with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on patients with CNV not due to AMD.