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


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Pneumonia




Clinical Trial: Dapsone 100 mg Versus 50 as Primary Prophylaxis for Pneumocystis carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)

This study has been completed.

Sponsored by: Jacobus Pharmaceutical
Information provided by: AIDS Clinical Trials Information Service

Purpose

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 Treatment or Intervention
Pneumonia, Pneumocystis carinii
HIV Infections
 Drug: Dapsone

MedlinePlus related topics:  AIDS;   Fungal Infections;   Pneumocystis Carinii Infections;   Pneumonia;   Respiratory Diseases

Study Type: Interventional
Study Design: Treatment, Dose Comparison

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

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).

Location Information


California
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States

More Information

Study ID Numbers:  007B
Record last reviewed:  December 1989
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002043
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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January 7, 2009



Page Updated: December 9, 2005
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