HIV Infections Clinical Trial
Official title:
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
To assess the safety and effectiveness of SCH 39304 as primary treatment of acute
cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance
therapy following successful treatment of acute disease are also evaluated.
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected
patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in
the majority of patients. Maintenance therapy is recommended but must be balanced against
the multiple toxicities of the drugs used and the problems associated with the weekly
administration of intravenous therapy. Treatments that are equally or more effective and
less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an
orally active antifungal drug that in animal studies is active against a wide range of
systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304
suggest that it might be of value in the treatment of cryptococcal meningitis.
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected
patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in
the majority of patients. Maintenance therapy is recommended but must be balanced against
the multiple toxicities of the drugs used and the problems associated with the weekly
administration of intravenous therapy. Treatments that are equally or more effective and
less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an
orally active antifungal drug that in animal studies is active against a wide range of
systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304
suggest that it might be of value in the treatment of cryptococcal meningitis.
HIV-infected patients with a diagnosis of acute cryptococcal meningitis, previously
untreated or relapsed following a successfully treated acute episode, are enrolled in the
study. SCH 39304 is administered orally once daily for 3 days followed by a lower dose once
daily for 12 weeks. Patients who respond to primary therapy are randomized to receive SCH
39304 maintenance therapy at a higher dose once weekly or at the lower dose once daily for
up to 12 months under this protocol.
;
Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |