Search Clinical Trials
By Condition
By Location (USA)
By Location (Other)
By Sponsor
Resources
Privacy Policy
About Us
Disclaimer
A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush Clinical research trials and A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush. A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush clinical trial. Test subjects typically receive the most expert healthcare available for their A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush



A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush

For Condition: Candidiasis, Oral,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from coming back or to wait and treat each episode of thrush. Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections. However, the number of patients with fluconazole-resistant thrush is increasing, and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance. Therefore, it is important to determine the most effective treatment strategy.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 948

Location and Contact Information:

Overall Study Official:
MitchellGoldman,  Study Chair, 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Cornell Univ Med Ctr
New York City,  New York,  10021
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Louis A Weiss Memorial Hosp
Chicago,  Illinois,  60640
United States
 

Univ of Minnesota
Minneapolis,  Minnesota,  55455
United States
 

Univ of Iowa Hosp and Clinic
Iowa City,  Iowa,  52242
United States
 

Univ of Nebraska Med Ctr
Omaha,  Nebraska,  681985130
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

UCLA CARE Ctr
Los Angeles,  California,  90095
United States
 

MetroHealth Med Ctr
Cleveland,  Ohio,  441091998
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

St Paul Ramsey Med Ctr
St. Paul,  Minnesota,  55101
United States
 

Univ of Texas Galveston
Galveston,  Texas,  775550435
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Univ of Washington
Seattle,  Washington,  98104
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Mem Sloan - Kettering Cancer Ctr
New York City,  New York,  10021
United States
 

Hennepin County Med Clinic
Minneapolis,  Minnesota,  55415
United States
 

Duke Univ Med Ctr
Durham,  North Carolina,  27710
United States
 

Emory Univ
Atlanta,  Georgia,  30308
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 

Philadelphia Veterans Administration Med Ctr
Philadelphia,  Pennsylvania,  19104
United States
 

Institute for Clinical Research
Washington D.C.,  District of Columbia,  20422
United States
 

Saint Clare's Hosp and Health Ctr
New York City,  New York,  10019
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Albert Einstein College of Medicine
Bronx,  New York,  10461
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York City,  New York,  10021
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Univ of California / San Diego Treatment Ctr
San Diego,  California,  921036325
United States
 

Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis,  Indiana,  46202
United States
 

Univ of Kentucky Lexington
Cincinnati,  Ohio,  45267
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville,  Tennessee,  37920
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

Boston Med Ctr
Boston,  Massachusetts,  02118
United States
 

Univ of Puerto Rico
San Juan,  ,  009365067
Puerto Rico
 

Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta,  Georgia,  303652225
United States
 

Howard Univ
Washington D.C.,  District of Columbia,  20059
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore,  Maryland,  212052196
United States
 

St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester,  New York,  14642
United States
 

Univ of Southern California / LA County USC Med Ctr
Los Angeles,  California,  900331079
United States
 

Queens Med Ctr
Honolulu,  Hawaii,  96816
United States
 

San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Case Western Reserve Univ
Cleveland,  Ohio,  44106
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 


Additional Information:
Study ID Numbers:
  ACTG 323; 
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000951

Other Hiv Infections Studies:
1. Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment

2. Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

3. A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

4. A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush

5. A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success with Fluconazole

Related Studies:

Other HIV Infections Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush

Modify your Search

  Other HIV Infections Clinical Trials
  Other Ohio Clinical Trials
  Other Cincinnati Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103