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Pneumonia, Pneumocystis CariniiPhase 1NCT00000739

Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection

A Phase 1 study testing Dapsone in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 46 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children. Read more about this study

Who is it for?
Ages 1 month to 12 years
What is being tested?
Dapsone
How many people
96 participants
Where
46 sitesin 2 countries
Study dates
Start not givento Jun 1998
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Rifampin and rifampin derivatives for up to 1 week during the study.
  • Rifabutin or other drugs that could alter dapsone metabolism (if prescribed by the child's primary care physician).
  • Patients must have:
  • Evidence of HIV infection.
Show all 10Show fewer
  • PER AMENDMENT 11/16/95:
  • Children who require prophylaxis. (Was written - Risk of developing PCP.)
  • Known intolerance to TMP / SMX.
  • Consent of parent or guardian. Patients entering this study may be co-enrolled in other ACTG pediatric studies.

Who cannot join

  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Glucose-6-phosphate dehydrogenase deficiency.
  • Known allergy to dapsone.
  • Concurrent Medication:
  • Excluded:
Show all 17Show fewer
  • Rifampin, rifampin derivatives, or oxidant drugs for more than 1 week.
  • Patients with the following prior conditions are excluded:
  • Serious or life-threatening reactions to TMP / SMX (e.g., anaphylaxis, Stevens-Johnson syndrome, hypotension) that would contraindicate therapy with sulfa drugs.
  • Prior Medication:
  • Excluded:
  • Prior dapsone.
  • Rifampin, rifampin derivatives, or oxidant drugs within 1 week prior to study entry.
  • TMP / SMX within 7 days prior to study entry (and toxicity must be clearly resolving).
  • Prior Treatment:
  • Excluded:
  • RBC transfusion within 4 weeks prior to study entry.

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

United States43 sites

  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

    Atlanta, Georgia, 30306

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado, 80218

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases

    Boston, Massachusetts, 02115

  • BMC, Div. of Ped Infectious Diseases

    Boston, Massachusetts, 02118

  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

    Brooklyn, New York, 11203

  • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases

    Charleston, South Carolina, 2942

  • Cook County Hosp.

    Chicago, Illinois, 60612

  • Chicago Children's CRS

    Chicago, Illinois, 60614

  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

    Chicago, Illinois, 60637

  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds

    Chicago, Illinois

  • Case CRS

    Cleveland, Ohio

  • Children's Hospital of Michigan NICHD CRS

    Detroit, Michigan, 48201

  • DUMC Ped. CRS

    Durham, North Carolina, 27710

  • North Shore-Long Island Jewish Health System, Dept. of Peds.

    Great Neck, New York, 11021

  • Univ. of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.

    Long Beach, California, 90801

  • Usc La Nichd Crs

    Los Angeles, California, 90033

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

    Los Angeles, California, 90095

  • St. Jude/UTHSC CRS

    Memphis, Tennessee, 38105

  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS

    Miami, Florida, 33161

  • UMDNJ - Robert Wood Johnson

    New Brunswick, New Jersey, 08903

  • Schneider Children's Hosp., Div. of Infectious Diseases

    New Hyde Park, New York, 11040

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana, 70112

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York, 10016

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Incarnation Children's Ctr.

    New York, New York, 10032

  • Harlem Hosp. Ctr. NY NICHD CRS

    New York, New York, 10037

  • Childrens Hosp. of the Kings Daughters

    Norfolk, Virginia, 23507

  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

    Oakland, California, 94609

  • St. Joseph's Hosp. & Med. Ctr. of New Jersey

    Paterson, New Jersey, 07103

  • The Children's Hosp. of Philadelphia IMPAACT CRS

    Philadelphia, Pennsylvania, 19104

  • St. Christopher's Hosp. for Children

    Philadelphia, Pennsylvania, 19134

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • Strong Memorial Hospital Rochester NY NICHD CRS

    Rochester, New York

  • UCSD Maternal, Child, and Adolescent HIV CRS

    San Diego, California, 92093

  • UW School of Medicine - CHRMC

    Seattle, Washington, 98105

  • Baystate Health, Baystate Med. Ctr.

    Springfield, Massachusetts, 01199

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York, 11794

  • SUNY Upstate Med. Univ., Dept. of Peds.

    Syracuse, New York, 13210

  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

    Torrance, California, 90502

  • Children's National Med. Ctr., ACTU

    Washington D.C., District of Columbia, 20010

  • Howard Univ. Washington DC NICHD CRS

    Washington D.C., District of Columbia, 20060

  • WNE Maternal Pediatric Adolescent AIDS CRS

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico3 sites

  • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds

    Bayamón

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 00936

  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

    San Juan

Other trials in Puerto Rico

About this study

Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children.

Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthrough in children receiving two different dose regimens of dapsone.

Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.

Read the detailed description

Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.

Ninety-six HIV-infected infants and children who are intolerant to trimethoprim / sulfamethoxazole ( TMP / SMX ) are randomized to receive oral dapsone in a lower dose once daily or at a higher dose once weekly. Treatment continues until the last patient enrolled has received at least 3 months of therapy. Blood samples are drawn between weeks 4 and 8, at weeks 12 and 24, and every 3 months thereafter during dapsone administration.

Being tested
Dapsone
Keywords
Pneumonia, Pneumocystis carinii, Dapsone, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Drug Administration Schedule
Medical subject headings
Pneumonia, Pneumocystis, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapsoneDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionJun 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Intervention model
Parallel groups
Enrolment
96 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000739
Sponsor's protocol ID
ACTG 179
Other IDs
11154
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Mirochnick M, Cooper E, McIntosh K. Pharmacokinetics of daily and weekly dapsone in HIV-infected children. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:159

  • Mirochnick M, Cooper E, Mcintosh K. Pharmacokinetics of daily and weekly dapsone in HIV-infected children. ACTG Protocol 179 Team. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):280 (unnumbered abstract)

  • Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

    PubMed 21037891

  • McIntosh K, Cooper E, Xu J, Mirochnick M, Lindsey J, Jacobus D, Mofenson L, Yogev R, Spector SA, Sullivan JL, Sacks H, Kovacs A, Nachman S, Sleasman J, Bonagura V, McNamara J. Toxicity and efficacy of daily vs. weekly dapsone for prevention of Pneumocystis carinii pneumonia in children infected with human immunodeficiency virus. ACTG 179 Study Team. AIDS Clinical Trials Group. Pediatr Infect Dis J. 1999 May;18(5):432-9. doi: 10.1097/00006454-199905000-00007.

    PubMed 10353516

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dapsone in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000739, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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