Know Cancer

or
forgot password

A Phase IV Randomized Study of the Use of Fluconazole as Chronic Suppressive Therapy Versus Episodic Therapy in HIV Positive Subjects With Recurrent Oropharyngeal Candidiasis


Phase 4
13 Years
N/A
Not Enrolling
Both
Candidiasis, Oral, HIV Infections

Thank you

Trial Information

A Phase IV Randomized Study of the Use of Fluconazole as Chronic Suppressive Therapy Versus Episodic Therapy in HIV Positive Subjects With Recurrent Oropharyngeal Candidiasis


This study will evaluate two different management strategies for patients with advanced HIV
infection who are at risk for recurrent and fluconazole-refractory oropharyngeal
candidiasis. The treatment duration will be at least 24 months in order to evaluate the
long-term effects of the treatment strategies on the development of fluconazole-refractory
thrush. In addition to investigating antifungal treatment as it relates to
fluconazole-refractory infections, the study will evaluate host factors and organism-related
factors in order to increase our understanding of the pathogenesis of oropharyngeal
candidiasis and fluconazole-refractory infections.

Prior to randomization to a long-term management strategy using fluconazole, patients are
stratified into one of three groups according to their baseline CD4+ count (cells/mm3):
0-49, 50-100, and 101-150. Patients without oropharyngeal candidiasis (no thrush present) at
enrollment and those patients who respond (no thrush present) to the initial acute therapy
for an active infection are randomized 1:1 to one of two management strategies for
fluconazole: Arm A (episodic therapy) or Arm B (chronic suppressive therapy with continuous
fluconazole). Patients are then followed for a duration of 24 months after enrollment of
the last subject. Patients with active oropharyngeal candidiasis at time of enrollment will
be treated with fluconazole for up to 2 weeks and patients who respond (no thrush present)
are then randomized to a long-term management strategy. Those who do not respond (refractory
disease) to the acute treatment are permanently discontinued from the study. Women in both
groups will have the option of being treated for vulvovaginal candidiasis either through or
outside the study.

Inclusion Criteria


Inclusion Criteria

You may be eligible for this study if you:

- Are HIV-positive.

- Have a CD4+ cell count less than 150 cells/mm3.

- Had at least one episode of thrush in the 24 months before study entry.

- Have a life expectancy of at least 12 months.

- Weigh at least 88 pounds.

- Are 13 years of age or older (consent of parent or guardian required if under 18).

- Agree to practice abstinence or use effective methods of birth control during the
study.

Exclusion Criteria

You will not be eligible for this study if you:

- Have an allergy to azoles.

- Have had 3 episodes or more of thrush within 12 weeks of study entry.

- Have a history of esophageal candidiasis.

- Have a history of fluconazole-resistant infection.

- Have an active opportunistic infection requiring treatment within 14 days before
study entry.

- Have a fungal infection requiring certain medications.

- Have a severe liver disease (e.g., cirrhosis).

- Are unable to tolerate oral medications.

- Take certain medications.

- Are pregnant or breast-feeding.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Mitchell Goldman

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 323

NCT ID:

NCT00000951

Start Date:

Completion Date:

May 2002

Related Keywords:

  • Candidiasis, Oral
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Fluconazole
  • Antifungal Agents
  • Candidiasis, Oral
  • Drug Administration Schedule
  • Pharyngeal Diseases
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Candidiasis
  • Candidiasis, Oral
  • HIV Seropositivity

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
UCLA CARE CtrLos Angeles, California  90095
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Univ of Miami School of MedicineMiami, Florida  331361013
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Indiana Univ HospIndianapolis, Indiana  462025250
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Boston Med CtrBoston, Massachusetts  02118
Univ of MinnesotaMinneapolis, Minnesota  55455
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
Cornell Univ Med CtrNew York, New York  10021
Mount Sinai Med CtrNew York, New York  10029
Univ of North CarolinaChapel Hill, North Carolina  275997215
Duke Univ Med CtrDurham, North Carolina  27710
Ohio State Univ Hosp ClinicColumbus, Ohio  432101228
Univ of Tennessee / E Tennessee Comprehensive Hemophilia CtrKnoxville, Tennessee  37920
Univ of WashingtonSeattle, Washington  98105
Johns Hopkins HospBaltimore, Maryland  21287
St Louis Regional Hosp / St Louis Regional Med CtrSt Louis, Missouri  63112
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Cook County HospChicago, Illinois  60612
Univ of Iowa Hosp and ClinicIowa City, Iowa  52242
Hennepin County Med ClinicMinneapolis, Minnesota  55415
St Paul Ramsey Med CtrSt Paul, Minnesota  55101
Univ of Nebraska Med CtrOmaha, Nebraska  681985130
Beth Israel Med CtrNew York, New York  10003
Saint Clare's Hosp and Health CtrNew York, New York  10019
Univ of CincinnatiCincinnati, Ohio  452670405
Univ of Pennsylvania at PhiladelphiaPhiladelphia, Pennsylvania  19104
Howard UnivWashington, District of Columbia  20059
Univ of HawaiiHonolulu, Hawaii  96816
Louis A Weiss Memorial HospChicago, Illinois  60640
Methodist Hosp of Indiana / Life Care ClinicIndianapolis, Indiana  46202
Univ of Kentucky LexingtonCincinnati, Ohio  45267
MetroHealth Med CtrCleveland, Ohio  441091998
Case Western Reserve UnivCleveland, Ohio  44106
Univ of Texas GalvestonGalveston, Texas  775550435
Queens Med CtrHonolulu, Hawaii  96816
Emory UnivAtlanta, Georgia  30308
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo CtrAtlanta, Georgia  303652225
Division of Inf Diseases/ Indiana Univ HospIndianapolis, Indiana  46202
State of MD Div of Corrections / Johns Hopkins Univ HospBaltimore, Maryland  212052196
St Vincent's Hosp / Mem Sloan-Kettering Cancer CtrNew York, New York  10021
St Mary's Hosp (Univ of Rochester/Infectious Diseases)Rochester, New York  14642
Philadelphia Veterans Administration Med CtrPhiladelphia, Pennsylvania  19104
Institute for Clinical ResearchWashington, District of Columbia  20422
Albert Einstein College of MedicineBronx, New York  10461