Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002043

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: December 1989

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)
Official Title ^ICMJE	Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)
Brief Summary	To determine which of 2 doses of dapsone is effective prophylaxis for Pneumocystis carinii pneumonia (PCP) in patients with oral thrush or hairy leukoplakia and less than 400 CD4 lymphocytes per mm3. To determine whether the long-term toxicities associated with daily dapsone in this population are tolerable.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Pneumonia, Pneumocystis Carinii HIV Infections
Intervention ^ICMJE	Drug: Dapsone
Study Arm (s)	Not Provided
Publications *	Not Provided
* 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	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria The patient must have HIV positive antibody test and presence of oral thrush or hairy leukoplakia. Patient must be willing and able to sign informed consent. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Prior Pneumocystis carinii pneumonia (PCP) or AIDS-defining condition. Prophylaxis for PCP in preceding 3 months. Absence of detectable glucose-6-phosphate dehydrogenase (G6PD) activity. Prior type I hypersensitivity (anaphylaxis, urticaria, angioedema) or exfoliative dermatitis during treatment with dapsone. History of poor compliance. Concurrent Medication: Excluded: Zidovudine (AZT). Patients with the following are excluded: Prior Pneumocystis carinii pneumonia (PCP) or AIDS-defining condition. Prophylaxis for PCP in preceding 3 months. Absence of detectable glucose-6-phosphate dehydrogenase (G6PD) activity. Concurrent or prior therapy with zidovudine (AZT). Prior type I hypersensitivity (anaphylaxis, urticaria, angioedema) or exfoliative dermatitis during treatment with dapsone. History of poor compliance. Prior Medication: Excluded: Zidovudine (AZT).
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002043
Other Study ID Numbers ^ICMJE	007B
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Jacobus Pharmaceutical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1989
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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