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.
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
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- 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
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
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.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- 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.
- First posted31 Aug 2001 (estimated)
- Study completionJun 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Pneumocystis CariniiStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Jacobus Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- McIntosh K, Study chairCooper E, Study chair
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 21037891McIntosh 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
- ClinicalTrials.gov ID
- NCT00000739
- Acronym / sponsor ID
- ACTG 179
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- Pneumonia, Pneumocystis carinii, Dapsone, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Drug Administration Schedule
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Jacobus Pharmaceutical
- Study completion
- Jun 1998 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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).
- Evidence of HIV infection.
- Children who require prophylaxis. (Was written - Risk of developing PCP.)
- Known intolerance to TMP / SMX.
Key exclusion criteria (17 listed)
- Glucose-6-phosphate dehydrogenase deficiency.
- Known allergy to dapsone.
- Rifampin, rifampin derivatives, or oxidant drugs for more than 1 week.
- Serious or life-threatening reactions to TMP / SMX (e.g., anaphylaxis, Stevens-Johnson syndrome, hypotension) that would contraindicate therapy with sulfa drugs.
- Prior dapsone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapsone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- BackgroundMirochnick 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
- BackgroundMirochnick 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)
- Background: PubMed 21037891Perrier 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.
- Background: PubMed 10353516McIntosh 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.
Related trials for Pneumonia, Pneumocystis Carinii
RecruitingPhase 3
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
Pneumocystis, Pneumocystis Pneumonia
Not yet recruitingPhase 4
Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives)
Pneumocystis, Pneumocystis Infection
Not yet recruitingPhase 4
How Long Should we Give Steroids for Patients With Severe PCP
Pneumocystis Pneumonia, Pneumocystis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
McIntosh K study chair
Cooper E study chair
46 sites in 2 countries: see every site and its status.
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.