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

Sponsored by:	Jacobus Pharmaceutical
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002043

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

MedlinePlus related topics: AIDS Pneumonia

Drug Information available for: Dapsone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison
Official Title:	Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)

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

Study ID Numbers:	007B
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002043
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

Study placed in the following topic categories:

Opportunistic Infections
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Pneumonia, Pneumocystis
Mycoses
Respiratory Tract Diseases
Respiratory Tract Infections
AIDS-Related Opportunistic Infections
Leukoplakia
Dapsone
Retroviridae Infections
Lung Diseases, Fungal

Leukoplakia, Oral
Pneumocystosis
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Folic Acid
Pneumocystis Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Antiprotozoal Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection

Folic Acid Antagonists
Pharmacologic Actions
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Lentivirus Infections
Leprostatic Agents

ClinicalTrials.gov processed this record on January 14, 2009