Predictive value of HIV-1 viral load on risk for opportunistic infection.
Susan Swindells, Scott Evans, Robert Zackin...
https://pubmed.ncbi.nlm.nih.gov/12045677Completed
Phase 4
Age: 13Years +
All Genders
ID00000951
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
948
Participants Needed
54
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 54 locations
1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
3
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
4
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
5
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
6
Howard Univ
Washington D.C., District of Columbia, United States, 20059
Status Unknown
7
Institute for Clinical Research
Washington D.C., District of Columbia, United States, 20422
Status Unknown
8
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
9
Emory Univ
Atlanta, Georgia, United States, 30308
Status Unknown
10
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, United States, 303652225
Status Unknown
11
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Status Unknown
12
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
13
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
14
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
15
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
16
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States, 60640
Status Unknown
17
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
18
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Status Unknown
19
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
20
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, United States, 52242
Status Unknown
21
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, United States, 212052196
Status Unknown
22
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
23
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Status Unknown
24
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Status Unknown
25
Hennepin County Med Clinic
Minneapolis, Minnesota, United States, 55415
Status Unknown
26
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Status Unknown
27
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, United States, 55101
Status Unknown
28
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
29
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
Status Unknown
30
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
31
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
32
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
33
Saint Clare's Hosp and Health Ctr
New York, New York, United States, 10019
Status Unknown
34
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
35
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
36
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
37
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
38
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, United States, 14642
Status Unknown
39
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
40
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
Status Unknown
41
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
42
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
43
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
44
Univ of Kentucky Lexington
Cincinnati, Ohio, United States, 45267
Status Unknown
45
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
46
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Status Unknown
47
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
48
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
49
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
50
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
51
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, United States, 37920
Status Unknown
52
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Status Unknown
53
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
54
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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