ClinicalTrials.gg
CompletedNCT00002043Updated Jun 24, 2005

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

An interventional study of Dapsone in Pneumonia, Pneumocystis Carinii and HIV Infections, sponsored by Jacobus Pharmaceutical. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Jacobus Pharmaceutical · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
12 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 62 studies in Pneumonia, Pneumocystis with a site in United States — none open to participants now, none under way, none of them phase 3. Pneumonia, Pneumocystis · United States.

No phase
23 of 62
none open now
Registered
1st of 62
by date
Lead sponsor
2 of 62
Jacobus Pharmaceutical

Among the 62 studies in Pneumonia, Pneumocystis with a site in United States, this one is one of 23 with no phase, and was the 1st registered.

Pneumonia, Pneumocystis

108 studies on the registry are indexed under Pneumonia, Pneumocystis; 16 are open to participants now.

Browse Pneumonia, Pneumocystis studies →

Open to participants now

None of the 62 studies in Pneumonia, Pneumocystis with a site in United States is open now. The open studies under Pneumonia, Pneumocystis, anywhere →

Who these studies take

Of the 9 Pneumonia, Pneumocystis studies recruiting now, 6 set no upper age limit and 1 stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.

This study: 12 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 62 studies in Pneumonia, Pneumocystis with a site in United States as a file.
02

Study summary

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.

03

Conditions studied

  • Pneumonia, Pneumocystis Carinii
  • HIV Infections

Keywords

  • AIDS-Related Opportunistic Infections
  • Pneumonia, Pneumocystis carinii
  • Leukoplakia, Oral
  • Dapsone
  • AIDS-Related Complex
  • Candidiasis, Oral
04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The patient must have positive antibody test and presence of oral thrush or hairy leukoplakia.

  • Patient must be willing and able to sign .

Exclusion criteria

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 (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).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

06

Study locations

1 site
  • UCLA CARE Ctr
    Los Angeles, California 90095, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002043
Lead sponsor
Jacobus Pharmaceutical
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 1989. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dapsone

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