Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)

NCT00000676

Last updated date
Study Location
Stanford CRS
Palo Alto, California, , United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis, Mycoses, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Concurrent Medication:

Required:

- Zidovudine (AZT).

- Antipneumocystis prophylaxis.

Allowed:

- Topical suppressive antifungal agents.

Eligibility requirements are:

- Participation in NIAID ACTG 081.

- No history of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis.

- Willingness to sign an informed consent.

- Transaminases < 5 x upper limit of normal.

- Noncompliance will not be a reason for withdrawal of a patient from the study, unless patient refuses further treatment.

Allowed:

- A history of oropharyngeal, vaginal or cutaneous candidiasis.

- Dermatophyte infections (i.e., tinea pedis) at entry but not active candida infection. Sites of suspected dermatophyte involvement other than the feet should have candida excluded by culture.

Prior Medication:

Allowed:

- Topical suppressive antifungal agents.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Co-existing Condition:


Patients with the following conditions or diseases are excluded:


- History of systemic fungal infection, including esophageal or systemic candidiasis,
cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or
aspergillosis.


- Active systemic fungal infection at time of enrollment.


- Active superficial fungal infection at time of entry. (Such patients may be treated
with topical antifungal agents and may be randomized if they are in clinical remission
14 days after completion of such therapy.)


Concurrent Medication:


Excluded:


- Amphotericin B.


- Fluconazole.


- Itraconazole.


- SCH 39304.


- Other systemic antifungals.


Patients with the following are excluded:


- Previous or currently active systemic fungal infection.


- History of allergy or intolerance to imidazole or azoles.


- Positive serum cryptococcal antigen titer at any dilution.


- Requiring multi-agent therapy for tuberculosis or for symptomatic Mycobacterium avium
infection.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Candidiasis, Mycoses, HIV InfectionsRandomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
NCT00000676
  1. Palo Alto, California
  2. San Diego, California
  3. San Francisco, California
  4. Miami, Florida
  5. Chicago, Illinois
  6. Chicago, Illinois
  7. Indianapolis, Indiana
  8. New Orleans, Louisiana
  9. Baltimore, Maryland
  10. Boston, Massachusetts
  11. Boston, Massachusetts
  12. Boston, Massachusetts
  13. Minneapolis, Minnesota
  14. St. Louis, Missouri
  15. Buffalo, New York
  16. New York, New York
  17. New York, New York
  18. Rochester, New York
  19. Chapel Hill, North Carolina
  20. Durham, North Carolina
  21. Cincinnati, Ohio
  22. Cleveland, Ohio
  23. Columbus, Ohio
  24. Pittsburgh, Pennsylvania
  25. Seattle, Washington
  26. Mbeya,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Candidiasis, Mycoses, HIV InfectionsNon-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
NCT00002038
  1. Groton, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
Official Title  ICMJE Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
Brief Summary

To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection.

Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.

Detailed Description

Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.

AMENDED: 11/01/90 Sufficient numbers of patients will be enrolled from all centers starting at week 8 of participation in the parent study to achieve a total of 240 evaluable patients who will remain in the nested study for a maximum duration of 45 months. Enrollment will continue until all eligible and interested 081 patients are enrolled. Fungal prophylaxis will begin at the time of enrollment into the nested study and will continue until an efficacy or safety end point is reached, until withdrawal from the nested study, or until death.

Original design: Patients included are those already enrolled in ACTG 081. Patients are enrolled from all centers at either week 8, 12, 16, 20, 24, 28, or 32 of participation in the parent study. They are randomized to receive either oral fluconazole or clotrimazole troches. Prophylaxis continues until a serious fungal infection develops, the end of the parent study is reached (which is expected to be December 1991), the patient withdraws from either the nested or parent study, or the patient dies. Clinical examination is performed at 2 weeks and then monthly (or more if clinically indicated) for the duration of antifungal prophylaxis; the schedule of evaluation is the same as for the parent study. There is a 1-month postprophylaxis follow-up after discontinuation of prophylaxis for any reason.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Prevention
Condition  ICMJE
  • Candidiasis
  • Mycoses
  • HIV Infections
Intervention  ICMJE
  • Drug: Clotrimazole
  • Drug: Fluconazole
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1993
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Concurrent Medication:

Required:

  • Zidovudine (AZT).
  • Antipneumocystis prophylaxis.

Allowed:

  • Topical suppressive antifungal agents.

Eligibility requirements are:

  • Participation in NIAID ACTG 081.
  • No history of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis.
  • Willingness to sign an informed consent.
  • Transaminases < 5 x upper limit of normal.
  • Noncompliance will not be a reason for withdrawal of a patient from the study, unless patient refuses further treatment.

Allowed:

  • A history of oropharyngeal, vaginal or cutaneous candidiasis.
  • Dermatophyte infections (i.e., tinea pedis) at entry but not active candida infection. Sites of suspected dermatophyte involvement other than the feet should have candida excluded by culture.

Prior Medication:

Allowed:

  • Topical suppressive antifungal agents.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or diseases are excluded:

  • History of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis.
  • Active systemic fungal infection at time of enrollment.
  • Active superficial fungal infection at time of entry. (Such patients may be treated with topical antifungal agents and may be randomized if they are in clinical remission 14 days after completion of such therapy.)

Concurrent Medication:

Excluded:

  • Amphotericin B.
  • Fluconazole.
  • Itraconazole.
  • SCH 39304.
  • Other systemic antifungals.

Patients with the following are excluded:

  • Previous or currently active systemic fungal infection.
  • History of allergy or intolerance to imidazole or azoles.
  • Positive serum cryptococcal antigen titer at any dilution.
  • Requiring multi-agent therapy for tuberculosis or for symptomatic Mycobacterium avium infection.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000676
Other Study ID Numbers  ICMJE ACTG 981
11504 ( Registry Identifier: DAIDS ES Registry Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Bozzettee S
Study Chair:Powderly WG
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP