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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dapsone

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

NCT ID

NCT00002043

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Jacobus Pharmaceutical

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

Pneumonia, Pneumocystis Carinii, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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