HIV Infections Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
NCT number | NCT00002399 |
Other study ID # | 288A |
Secondary ID | C96-209I96-209 |
Status | Completed |
Phase | Phase 2 |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.
Status | Completed |
Enrollment | 500 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria Patients must have: - Documented HIV seropositivity (by Western blot or other approved confirmatory test) prior to enrollment. - Pseudomembranous oropharyngeal candidiasis. - Fungal stain or KOH consistent with Candida species, confirmed by a positive mycologic culture. - Ability to swallow study medication. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms and conditions are excluded: - Medical condition requiring use of prohibited drugs. - Primary HIV seroconversion-related mucosal candidiasis. - Systemic candidiasis. - All forms of OPC other than pseudomembranous (unless accompanied by pseudomembranous OPC). - Documented or suspected fungal esophagitis in patients with symptoms of esophagitis. - EKG with prolonged QTc interval or clinically-significant abnormalities. Concurrent Medication: Excluded: - Systemic antifungals (IV or oral). - Topical oral antifungals, e.g., Nystatin, Mycelex, etc. - Medications known to interact with azoles and that may lead to life-threatening side effects: - terfenadine, astemizole, cisapride, ebastine, triazolam, midazolam. - Medications known to lower the serum concentration/efficacy of azole antifungals: - rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid, H2 blockers. - Cytokines (except erythropoietin), interferon, or lymphocyte replacement therapy unless patient already taking these agents for at least 30 days prior to enrollment. - Protease inhibitors, starting for the first time, 30 days prior to study enrollment. - Cytotoxic therapy for cancer. - Oral or intravenous corticosteroids at supraphysiologic doses (prednisone 10 mg/day or greater; hydrocortisone 40 mg/day or greater; dexamethasone 2 mg/day or greater. Patients with any of the following prior conditions are excluded: - Prior enrollment in this study. - Less than 3 months life expectancy. - History of hypersensitivity to azole antifungals. - History of failed therapy with fluconazole 100 mg/day for 2 weeks in the last 3 months. Prior Medication: Excluded (wash-outs for medications): - Systemic antifungals (IV, oral) within 14 days prior to enrollment. - Topical oral antifungals within 1 day prior to enrollment. - Oral or intravenous corticosteroids at supraphysiologic doses within 10 days prior to enrollment. - Astemizole within 10 days prior to enrollment. - Drugs known to lower the serum concentration/efficacy of azole antifungals within 30 days prior to enrollment. - Investigational drug (unlicensed new chemical entity) use within 30 days prior to enrollment. Current known drug abuse, in the opinion of the lead investigator, that would interfere with the subject's participation in the study. |
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Centro de Micologia / Facultad de Medicina UBA | Buenos Aires | |
Argentina | Hosp Fernandez | Buenos Aires | |
Belgium | CHU Saint Pierre | Brussels | |
Canada | Victoria Gen Hosp | Halifax | Nova Scotia |
Canada | Montreal Gen Hosp | Montreal | Quebec |
Canada | St Paul's Hosp | Vancouver | British Columbia |
Chile | Fundacion Arriaran | Santiago | |
Dominican Republic | Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler | Ensanche NACO/ Santo Domingo | |
Ethiopia | Faculty of Medicine / Dept of Internal Medicine | Addis Ababa | |
France | Hopital Raymond Poincare | Garches | |
France | Hopital de La Conception | Maseille | |
France | Hopital Guy de Chauliac Service des Maladies Infectieuses | Montpellier | |
France | Service des Maladies Infectieuses Hopital de l Archet | Nice | |
France | Hopital Rothchild | Paris | |
France | Hopital de l Institut Pasteur | Paris cedex | |
France | Service des Maladies Infectieuses | Tours Cedex | |
France | Service des Maladies Infectieuses | Villejuif Cedex | |
Germany | Rheinische Friedrich Wilhelms Universitaet Medizinische | Bonn | |
Germany | Heinrich Heine Universitat | Dusseldorf | |
Germany | Allgemeines Krankenhaus St Georg | Hamburg | |
Germany | Universitaets Krankenhaus Eppendorf Medizinische Kernklinik | Hamburg | |
Germany | Staedtisches Krankenhaus Kiel | Kiel | |
Germany | Universitaet Klinik Koln | Koln | |
Germany | Universitat Munchen / Medizinische Poliklinik | Munich 2 | |
Guatemala | Hosp Roosevelt Chief Infectious Diseases Unit | Guatemala | |
Honduras | Hosp Regional del Seguro Social | San Pedro Sula | |
Israel | Sheba Med Ctr | Tel Hashomer | |
Mexico | Hosp de Especialidades Centro Medico La Raza | Mexico | |
Panama | Royal Ctr | Panama | |
South Africa | Daniel Rudolph Malan | Port Elizabeth | |
South Africa | The Studio | Rosebank | |
South Africa | Univ of Stellenbosch Med School Depart Med Phys | Tygerberg | |
Spain | Hosp Clinic | Barcelona | |
Spain | Hosp Valle D Hebron | Barcelona | |
Thailand | Program on AIDS / Thai Red Cross Society | Bangkok | |
United States | Ponce de Leon Med Ctr | Atlanta | Georgia |
United States | Med College of Georgia | Augusta | Georgia |
United States | Rush Med College / Rush Presbyterian - St Luke's Med Cen | Chicago | Illinois |
United States | Univ of Texas Southwestern Med Ctr | Dallas | Texas |
United States | Wayne State Univ / Harper Hosp | Detroit | Michigan |
United States | Duke Univ Med Ctr | Durham | North Carolina |
United States | Univ of Texas / Med School at Houston | Houston | Texas |
United States | Wishard Hosp | Indianapolis | Indiana |
United States | Northeast Arkansas Clinic | Jonesboro | Arkansas |
United States | Mercy Hosp | Miami | Florida |
United States | Miami Veterans Administration Med Ctr | Miami | Florida |
United States | Vanderbilt Univ Med Ctr | Nashville | Tennessee |
United States | St Michaels Med Ctr | Newark | New Jersey |
United States | Thomas Jefferson Univ / Division of Infectious Disease | Philadelphia | Pennsylvania |
United States | Univ of Texas Health Sciences Ctr | San Antonio | Texas |
United States | Infections Ltd / Physicians Med Ctr | Tacoma | Washington |
United States | Tucson Veterans Administration Med Ctr | Tucson | Arizona |
Venezuela | Policlinica Metropolitana | Caracas |
Lead Sponsor | Collaborator |
---|---|
Schering-Plough |
United States, Venezuela, Argentina, Belgium, Canada, Chile, Dominican Republic, Ethiopia, France, Germany, Guatemala, Honduras, Israel, Mexico, Panama, South Africa, Spain, Thailand,
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 |