A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | September 1996 |
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:
- Steroids and intravenous immune globulin (IVIG).
Patients must have:
- Documented HIV infection.
- Need for PCP prophylaxis.
- Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX).
One of the following required conditions:
- Known intolerance or allergy to dapsone; G6PD deficiency; history of serious or life-threatening reaction to TMP-SMX; exclusion from protocol ACTG 179; election by parent not to enroll child on ACTG 179; or receiving medical care at sites not participating in ACTG 179.
NOTE:
- Co-enrollment in other ACTG pediatric studies is permitted.
Consent of parent or guardian is required.
Prior Medication:
Allowed:
- Prior pentamidine.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Active PCP.
- Pancreatitis defined as amylase elevation associated with an elevated lipase that is > 2 x upper limit of normal.
Prior Medication:
Excluded:
- TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).
Contacts and Locations| United States, California | |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | |
| Los Angeles, California, United States, 90095 | |
| Usc La Nichd Crs | |
| Los Angeles, California, United States, 90033 | |
| Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | |
| Oakland, California, United States | |
| United States, District of Columbia | |
| Howard Univ. Washington DC NICHD CRS | |
| Washington, District of Columbia, United States, 20060 | |
| Children's National Med. Ctr., ACTU | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Illinois | |
| Chicago Children's CRS | |
| Chicago, Illinois, United States, 60614 | |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Tulane/LSU Maternal/Child CRS | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, New York | |
| Harlem Hosp. Ctr. NY NICHD CRS | |
| New York, New York, United States, 10037 | |
| NYU Med. Ctr., Dept. of Medicine | |
| New York, New York, United States, 10016 | |
| SUNY Upstate Med. Univ., Dept. of Peds | |
| Syracuse, New York, United States | |
| Puerto Rico | |
| San Juan City Hosp. PR NICHD CRS | |
| San Juan, Puerto Rico, 00936 | |
| Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS | |
| San Juan, Puerto Rico | |
| Study Chair: | Van Dyke R | |
| Study Chair: | Pramberg J |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001027 History of Changes |
| Other Study ID Numbers: | ACTG 189, 11164 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Pneumonia, Pneumocystis carinii Pentamidine Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Pentamidine Trimethoprim Trimethoprim-Sulfamethoxazole Combination Sulfamethoxazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Antiparasitic Agents Trypanocidal Agents |
ClinicalTrials.gov processed this record on June 18, 2013