Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That...
Invasive CandidiasisMucocutaneous Candidiasis8 moreThis 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.
Efficacy and Safety of High-dose L-AmB for Disseminated Histoplasmosis in AIDS
Disseminated Histoplasma Capsulatum InfectionAIDS and Infections2 moreHistoplasmosis is a systemic mycosis endemic in the Americas and Brazil. HIV-infected patients are susceptible to disseminated histoplasmosis (HD), AIDS-defining illness. The classic diagnosis requires a fungal culture that takes 4-6 weeks to grow. Brazilian patients are diagnosed by culture or by histopathology and American patients have their diagnosis in 1-2 days, by Histoplasma antigen detection in urine. Amphotericin B treatment Liposomal (L-AmB) is recommended by the American Society for Infectious Diseases and WHO, while the Brazilian AIDS Program does not fund the use of L-AmB, delegating responsibility to the states. As a result, patients with AIDS+HD do not have access to new diagnostic tests or L-AmB, receiving late treatment with AmB-d, which results in increased mortality >45%. The single high dose liposomal amphotericin B treatment study, aims to improve the availability of access to medication, something that has already been demonstrated successfully by our group in a phase II study. This proposal seeks to determine the efficacy and safety of two L-AmB regimens as induction therapy for HD in AIDS patients: 10 mg/kg single dose versus 3 mg/kg for two weeks.
Macugen for Histoplasmosis
Ocular HistoplasmosisChoroidal NeovascularizationThe purpose of this study is to evaluate the safety and effect on visual acuity of Macugen (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary to the ocular histoplasmosis syndrome (OHS).
Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City...
Acquired Immunodeficiency SyndromeHistoplasmosis AIDS2 moreIn 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.
A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients...
HIV InfectionsHistoplasmosisTo test the effectiveness of itraconazole in preventing the recurrence of disseminated histoplasmosis in AIDS patients. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse.
Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome
Choroidal NeovascularizationPresumed Ocular HistoplasmosisThe 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).
A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep...
MycosesCandidiasis5 moreThe purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of itraconazole (ITCZ) oral solution in participants with Systemic Fungal Infection (SFI) and those with febrile (with fever) neutropenia (FN, decrease in white blood cells) suspected of fungal infection.
A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in...
HIV InfectionsHistoplasmosisTo evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
HistoplasmosisSporotrichosis1 moreOBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211). II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.
A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected...
HIV InfectionsHistoplasmosisTo assess the safety and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.