|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002399 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Candidiasis, Oral HIV Infections |
Drug: Posaconazole Drug: Fluconazole |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded (wash-outs for medications):
Current known drug abuse, in the opinion of the lead investigator, that would interfere with the subject's participation in the study.
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Tucson Veterans Administration Med Ctr | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| Northeast Arkansas Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, Florida | |
| Miami Veterans Administration Med Ctr | |
| Miami, Florida, United States, 33125 | |
| Mercy Hosp | |
| Miami, Florida, United States, 33133 | |
| United States, Georgia | |
| Ponce de Leon Med Ctr | |
| Atlanta, Georgia, United States, 30308 | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Rush Med College / Rush Presbyterian - St Luke's Med Cen | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Wishard Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State Univ / Harper Hosp | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| St Michaels Med Ctr | |
| Newark, New Jersey, United States, 07102 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Thomas Jefferson Univ / Division of Infectious Disease | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 372321302 | |
| United States, Texas | |
| Univ of Texas Health Sciences Ctr | |
| San Antonio, Texas, United States, 78284 | |
| Univ of Texas / Med School at Houston | |
| Houston, Texas, United States, 77030 | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Infections Ltd / Physicians Med Ctr | |
| Tacoma, Washington, United States, 98405 | |
| Argentina | |
| Hosp Fernandez | |
| Buenos Aires, Argentina | |
| Centro de Micologia / Facultad de Medicina UBA | |
| Buenos Aires, Argentina | |
| Belgium | |
| CHU Saint Pierre | |
| Brussels, Belgium | |
| Canada, British Columbia | |
| St Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Nova Scotia | |
| Victoria Gen Hosp | |
| Halifax, Nova Scotia, Canada | |
| Canada, Quebec | |
| Montreal Gen Hosp | |
| Montreal, Quebec, Canada | |
| Chile | |
| Fundacion Arriaran | |
| Santiago, Chile | |
| Dominican Republic | |
| Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler | |
| Ensanche NACO/ Santo Domingo, Dominican Republic | |
| Ethiopia | |
| Faculty of Medicine / Dept of Internal Medicine | |
| Addis Ababa, Ethiopia | |
| France | |
| Service des Maladies Infectieuses | |
| Villejuif Cedex, France | |
| Hopital de l Institut Pasteur | |
| Paris cedex, France | |
| Service des Maladies Infectieuses | |
| Tours Cedex, France | |
| Hopital Guy de Chauliac Service des Maladies Infectieuses | |
| Montpellier, France | |
| Hopital Rothchild | |
| Paris, France | |
| Hopital Raymond Poincare | |
| Garches, France | |
| Service des Maladies Infectieuses Hopital de l Archet | |
| Nice, France | |
| Hopital de La Conception | |
| Maseille, France | |
| Germany | |
| Universitat Munchen / Medizinische Poliklinik | |
| Munich 2, Germany | |
| Universitaet Klinik Koln | |
| Koln, Germany | |
| Allgemeines Krankenhaus St Georg | |
| Hamburg, Germany | |
| Universitaets Krankenhaus Eppendorf Medizinische Kernklinik | |
| Hamburg, Germany | |
| Rheinische Friedrich Wilhelms Universitaet Medizinische | |
| Bonn, Germany | |
| Heinrich Heine Universitat | |
| Dusseldorf, Germany | |
| Staedtisches Krankenhaus Kiel | |
| Kiel, Germany | |
| Guatemala | |
| Hosp Roosevelt Chief Infectious Diseases Unit | |
| Guatemala, Guatemala | |
| Honduras | |
| Hosp Regional del Seguro Social | |
| San Pedro Sula, Honduras | |
| Israel | |
| Sheba Med Ctr | |
| Tel Hashomer, Israel | |
| Mexico | |
| Hosp de Especialidades Centro Medico La Raza | |
| Mexico, Mexico | |
| Panama | |
| Royal Ctr | |
| Panama, Panama | |
| South Africa | |
| Univ of Stellenbosch Med School Depart Med Phys | |
| Tygerberg, South Africa | |
| Daniel Rudolph Malan | |
| Port Elizabeth, South Africa | |
| The Studio | |
| Rosebank, South Africa | |
| Spain | |
| Hosp Valle D Hebron | |
| Barcelona, Spain | |
| Hosp Clinic | |
| Barcelona, Spain | |
| Thailand | |
| Program on AIDS / Thai Red Cross Society | |
| Bangkok, Thailand | |
| Venezuela | |
| Policlinica Metropolitana | |
| Caracas, Venezuela | |
More Information
| Study ID Numbers: | 288A, C96-209, I96-209 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002399 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Fluconazole Antifungal Agents Candidiasis Triazoles |
|
Mouth Diseases Trypanocidal Agents Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Candidiasis, Oral Slow Virus Diseases Candidiasis Infection Mycoses Antiparasitic Agents Antifungal Agents Therapeutic Uses |
Antibiotics, Antifungal Posaconazole Retroviridae Infections Fluconazole RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Stomatognathic Diseases |