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

Sponsor

Jacobus Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00002043

Collaborator

(none)

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Dapsone	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 0 Years

Sexes Eligible for Study:

All

Accepts 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.