Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 1999
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a randomized, multicenter, double-blind study consisting of 5 arms (4 dose levels of SCH 56592 vs fluconazole) in the treatment of oropharyngeal candidiasis (OPC) in HIV-positive patients.


Recruitment information / eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Posaconazole

Fluconazole


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Schering-Plough

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Belgium,  Canada,  Chile,  Dominican Republic,  Ethiopia,  France,  Germany,  Guatemala,  Honduras,  Israel,  Mexico,  Panama,  South Africa,  Spain,  Thailand, 

See also
  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