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

NCT ID: NCT00002043

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Pneumonia, Pneumocystis Carinii HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Dapsone

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jacobus Pharmaceutical

INDUSTRY

Sponsor Role lead

Locations

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UCLA CARE Ctr

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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007B

Identifier Type: -

Identifier Source: org_study_id