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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002043
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1989
History of Changes
  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 Intervention
Pneumonia, Pneumocystis Carinii
HIV Infections
 Drug: Dapsone

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Drug Information available for: Dapsone
U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002043

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jacobus Pharmaceutical
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002043     History of Changes
Other Study ID Numbers: 007B
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Leukoplakia, Oral
 Dapsone
AIDS-Related Complex
Candidiasis, Oral

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Dapsone
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 10, 2013