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

NCT00000739 | Completed Phase 1

• 2 other identifiers: ACTG 17911154
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 46

Brief 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. 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.

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

Pneumonia, Pneumocystis carinii; Dapsone; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Drug Administration Schedule

Interventions

Dapsone DRUG

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Jacobus Pharmaceutical: collaborator

Study Sites (46)

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

Long Beach, California, 90801, United States

Location

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

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

Los Angeles, California, 90095, United States

Location

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

Oakland, California, 94609, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, 92093, United States

Location

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

Torrance, California, 90502, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, 80218, United States

Location

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, 20010, United States

Location

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20060, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

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

Atlanta, Georgia, 30306, United States

Location

Cook County Hosp.

Chicago, Illinois, 60612, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

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

Chicago, Illinois, 60637, United States

Location

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

Chicago, Illinois, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, 02118, United States

Location

Baystate Health, Baystate Med. Ctr.

Springfield, Massachusetts, 01199, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, 01655, United States

Location

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, 48201, United States

Location

UMDNJ - Robert Wood Johnson

New Brunswick, New Jersey, 08903, United States

Location

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

Paterson, New Jersey, 07103, United States

Location

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

Brooklyn, New York, 11203, United States

Location

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

Great Neck, New York, 11021, United States

Location

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

New Hyde Park, New York, 11040, United States

Location

NYU Med. Ctr., Dept. of Medicine

New York, New York, 10016, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Incarnation Children's Ctr.

New York, New York, 10032, United States

Location

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, 10037, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Strong Memorial Hospital Rochester NY NICHD CRS

Rochester, New York, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, 11794, United States

Location

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

Syracuse, New York, 13210, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

Case CRS

Cleveland, Ohio, United States

Location

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, 19104, United States

Location

St. Christopher's Hosp. for Children

Philadelphia, Pennsylvania, 19134, United States

Location

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

Charleston, South Carolina, 2942, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105, United States

Location

Childrens Hosp. of the Kings Daughters

Norfolk, Virginia, 23507, United States

Location

UW School of Medicine - CHRMC

Seattle, Washington, 98105, United States

Location

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

Bayamón, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

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

San Juan, Puerto Rico

Location

Related Publications (4)

• 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

  BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 21037891 BACKGROUND

• 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.

  PMID: 10353516 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Dapsone

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals

Study Officials

• McIntosh K

  STUDY CHAIR

• Cooper E

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 1998
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (43); PR (3)