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OpenTrials
Completed

NCT Number: NCT00002043

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

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.

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Key information

Conditions

Pneumonia, Pneumocystis Carinii AIDS-Related Complex AIDS-Related Opportunistic Infections Bacterial Infections and Mycoses Blood-Borne Infections Candidiasis Candidiasis, Oral Communicable Diseases Genital Diseases HIV Infections Head and Neck Neoplasms Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Leukoplakia Leukoplakia, Oral Lung Diseases Lung Diseases, Fungal Mouth Diseases Mouth Neoplasms Mycoses Neoplasms Neoplasms by Site Opportunistic Infections Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis Precancerous Conditions RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stomatognathic Diseases Urogenital Diseases Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dapsone

Drug

Sponsors and collaborators

Lead sponsor

Jacobus Pharmaceutical

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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