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

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dapsone
Sponsored by
Jacobus Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Leukoplakia, Oral, Dapsone, AIDS-Related Complex, Candidiasis, Oral

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • UCLA CARE Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Jacobus Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00002043
Brief Title
Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)
Official Title
Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jacobus Pharmaceutical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Leukoplakia, Oral, Dapsone, AIDS-Related Complex, Candidiasis, Oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dapsone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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

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