Expired Study
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Long Beach, California 90801


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria 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. 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. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Glucose-6-phosphate dehydrogenase deficiency. - Known allergy to dapsone. Concurrent Medication: Excluded: - 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.


Study is Available At:


Original ID:

ACTG 179


NCT ID:

NCT00000739


Secondary ID:

11154


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

1 Month


Maximum Age:

12 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

Unspecified


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study,


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

96


Enrollment Type:


Overall Contact Information

Official Name:McIntosh K
Study Chair

Study Dates

Completion Date:June 1998
Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 30, 2012
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Dapsone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Jacobus Pharmaceutical

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:10353516
Reference Type:Reference
Citation:Dankner WM, Lindsey JC, Levin MJ. Correlates of opportunistic infections in children infected with the human immunodeficiency virus managed before highly active antiretroviral therapy. Pediatr Infect Dis J. 2001 Jan;20(1):40-8.
PMID:11176565
Reference Type:Reference
Citation: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)
Reference Type:Reference
Citation: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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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