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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Fujisawa Pharmaceutical Co |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001027 |
Purpose
Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of these regimens in this patient population.
Secondary: To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis.
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole |
| Estimated Enrollment: | 32 |
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.
Thirty-two children are randomized to one of two treatment arms. Patients receive pentamidine on either a biweekly or a monthly treatment schedule. Treatment continues until the last child enrolled has received at least 6 months of pentamidine. Patients are stratified according to age < 24 months or age >= 24 months. Steady-state pharmacokinetics will be examined in a subsample of 20 patients.
Eligibility| Ages Eligible for Study: | 1 Month to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
One of the following required conditions:
NOTE:
Consent of parent or guardian is required.
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Prior Medication:
Excluded:
Contacts and Locations| United States, Alabama | |
| Univ of Alabama at Birmingham Schl of Med / Pediatrics | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| 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, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| 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, New Jersey | |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 071072198 | |
| United States, New York | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Cornell Univ Med College | |
| New York, New York, United States, 10021 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Children's Hosp Pact Prog / Children's Hosp of Buffalo | |
| Buffalo, New York, United States, 14222 | |
| Beth Israel Med Ctr / Pediatrics | |
| New York, New York, United States, 10003 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Study Chair: | Van Dyke R | |
| Study Chair: | Pramberg J |
More Information
| Study ID Numbers: | ACTG 189 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001027 |
| Health Authority: | United States: Federal Government |
|
Pneumonia, Pneumocystis carinii Pentamidine Acquired Immunodeficiency Syndrome AIDS-Related Complex |
|
Sexually Transmitted Diseases, Viral Trimethoprim Clotrimazole Miconazole Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis Mycoses Respiratory Tract Infections Respiratory Tract Diseases Pentamidine Retroviridae Infections Lung Diseases, Fungal Sulfamethoxazole |
Pneumocystosis Acquired Immunodeficiency Syndrome Tioconazole AIDS-Related Complex Immunologic Deficiency Syndromes Virus Diseases Folic Acid Pneumocystis Infections HIV Infections Lung Diseases Sexually Transmitted Diseases Pneumonia |
|
Anti-Infective Agents Trypanocidal Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Anti-Infective Agents, Urinary |
Folic Acid Antagonists Renal Agents Infection Pharmacologic Actions Antimalarials Antiparasitic Agents Antifungal Agents Therapeutic Uses Lentivirus Infections |
