Skip to main content
OpenTrials
Completed

NCT Number: NCT00002446

Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Candidiasis, Oral AIDS-Related Opportunistic Infections Bacterial Infections and Mycoses Blood-Borne Infections Candidiasis Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mouth Diseases Mycoses Opportunistic Infections Otorhinolaryngologic Diseases Pharyngeal Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Stomatognathic Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Queen Elizabeth Hosp Respiratory Unit, Saint Michael, Barbados

Loading trial locations.

About this study

Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

You may be eligible for this study if you:

  • Are at least 18 years old.
  • Are HIV-positive.
  • Have thrush (oropharyngeal candidiasis).
  • Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).
  • Are able to take study medication and return for clinic visits during the study.
  • Are expected to live for at least 2 months.

Exclusion criteria

You will not be eligible for this study if you:

  • Have received protease inhibitors for the first time within 30 days prior to study entry.
  • Have received certain medications.
  • Have certain other types of fungal infections.
  • Have certain types of cancer.
  • Have received SCH 56592 within 3 months prior to study entry.
  • Are pregnant or breast-feeding.
  • Cannot take medications by mouth.
  • Are allergic to azole drugs.
  • Have certain medical conditions.
  • Have been in this study before.

Treatment and study plan

Posaconazole

Drug

Fluconazole

Drug

Sponsors and collaborators

Lead sponsor

Schering-Plough

Industry

Registry information

Official study title

Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

Important dates

Study start
1998
First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.