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:
Jacobus Pharmaceutical
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
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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:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002043
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
| 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 Pneumonia AIDS-Related Complex Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Slow Virus Diseases Lung Diseases, Fungal Mycoses Pneumocystis Infections Dapsone Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on September 30, 2016