Dapsone 100 Mg Versus 50 as Primary Prophylaxis for NCT00002043

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00002043
Other study ID #	007B
Secondary ID
Status	Completed
Phase	N/A
First received	November 2, 1999
Last updated	June 23, 2005

Study information
Verified date	December 1989
Source	NIH AIDS Clinical Trials Information Service
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	12 Years and older
Eligibility	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).

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dapsone

Locations
Country	Name	City	State
United States	UCLA CARE Ctr	Los Angeles	California

Sponsors *(1)*
Lead Sponsor	Collaborator
Jacobus Pharmaceutical

Country where clinical trial is conducted

United States,

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

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted