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| Sponsor: | Jacobus Pharmaceutical |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000739 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Dapsone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection |
| Estimated Enrollment: | 96 |
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.
Eligibility| Ages Eligible for Study: | 1 Month to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
PER AMENDMENT 11/16/95:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham Schl of Med / Pediatrics | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |
| La Jolla, California, United States, 920930672 | |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | |
| Los Angeles, California, United States, 905022004 | |
| Long Beach Memorial (Pediatric) | |
| Long Beach, California, United States, 90801 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Children's Hosp of Oakland | |
| Oakland, California, United States, 946091809 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| United States, Colorado | |
| Children's Hosp of Denver | |
| Denver, Colorado, United States, 802181088 | |
| United States, District of Columbia | |
| Howard Univ Hosp | |
| Washington, District of Columbia, United States, 20060 | |
| Children's Hosp of Washington DC | |
| Washington, District of Columbia, United States, 200102916 | |
| United States, Florida | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| Univ of Florida Health Science Ctr / Pediatrics | |
| Jacksonville, Florida, United States, 32209 | |
| United States, Georgia | |
| Emory Univ Hosp / Pediatrics | |
| Atlanta, Georgia, United States, 30306 | |
| United States, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Illinois College of Medicine / Pediatrics | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Chicago Children's Hosp | |
| Chicago, Illinois, United States, 606371470 | |
| United States, Louisiana | |
| Tulane Univ / Charity Hosp of New Orleans | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| Boston City Hosp / Pediatrics | |
| Boston, Massachusetts, United States, 02118 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Univ of Massachusetts Med School | |
| Worcester, Massachusetts, United States, 016550001 | |
| United States, Michigan | |
| Children's Hosp of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| UMDNJ - Robert Wood Johnson Med School / Pediatrics | |
| New Brunswick, New Jersey, United States, 089030019 | |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 071072198 | |
| Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| King's County Hosp Ctr / Pediatrics | |
| Brooklyn, New York, United States, 11203 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Cornell Univ Med College | |
| New York, New York, United States, 10021 | |
| North Shore Univ Hosp | |
| Great Neck, New York, United States, 11021 | |
| Schneider Children's Hosp | |
| New Hyde Park, New York, United States, 11040 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Mount Sinai Med Ctr / Pediatrics | |
| New York, New York, United States, 10029 | |
| Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | |
| Syracuse, New York, United States, 13210 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| State Univ of New York at Stony Brook | |
| Stony Brook, New York, United States, 117948111 | |
| Beth Israel Med Ctr / Pediatrics | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 277103499 | |
| United States, Ohio | |
| Cincinnati Children's Hosp / Univ Hosp | |
| Cincinnati, Ohio, United States, 452292899 | |
| United States, Pennsylvania | |
| Children's Hosp of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 191044318 | |
| Saint Christopher's Hosp for Children | |
| Philadelphia, Pennsylvania, United States, 191341095 | |
| United States, South Carolina | |
| Med Univ of South Carolina | |
| Charleston, South Carolina, United States, 294253312 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hosp of Memphis | |
| Memphis, Tennessee, United States, 381052794 | |
| United States, Texas | |
| Hermann Hosp / Univ Texas Health Science Ctr | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Children's Hosp of the King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Children's Hospital & Medical Center / Seattle ACTU | |
| Seattle, Washington, United States, 981050371 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Study Chair: | McIntosh K | |
| Study Chair: | Cooper E |
More Information
| Study ID Numbers: | ACTG 179 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000739 History of Changes |
| Health Authority: | Unspecified |
|
Pneumonia, Pneumocystis carinii Dapsone Acquired Immunodeficiency Syndrome AIDS-Related Complex Drug Administration Schedule |
|
Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Anti-Bacterial Agents Pneumonia, Pneumocystis Mycoses Antimalarials Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses |
Dapsone Retroviridae Infections Lung Diseases, Fungal RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Pneumocystis Infections HIV Infections Lung Diseases Sexually Transmitted Diseases |