Pneumonia, Pneumocystis CariniiPhase 1NCT00001027
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
A Phase 1 study testing Pentamidine isethionate in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- What is being tested?
- Pentamidine isethionate
- How many people
- 32 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Start not givento Sep 1996
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Steroids and intravenous immune globulin (IVIG).
- Patients must have:
- Documented HIV infection.
- Need for PCP prophylaxis.
Show all 15Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Chicago Children's CRS
Chicago, Illinois, 60614
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60637
Usc La Nichd Crs
Los Angeles, California, 90033
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 90095
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California
SUNY Upstate Med. Univ., Dept. of Peds
Syracuse, New York
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060
Puerto Rico2 sites
San Juan City Hosp. PR NICHD CRS
San Juan, 00936
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan
About this study
Official title: A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
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.
Read the detailed description
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.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Being tested
- Pentamidine isethionate
- Keywords
- Pneumonia, Pneumocystis carinii, Pentamidine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Medical subject headings
- Pneumonia, Pneumocystis, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentamidine isethionateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionSep 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Pneumocystis CariniiStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 32 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Fujisawa Pharmaceutical Co
- Responsible party
- Sponsor
- Investigators
- Van Dyke R, Study chairPramberg J, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001027
- Sponsor's protocol ID
- ACTG 189
- Other IDs
- 11164
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
- ClinicalTrials.gov ID
- NCT00001027
- Acronym / sponsor ID
- ACTG 189
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- Pneumonia, Pneumocystis carinii, Pentamidine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Fujisawa Pharmaceutical Co
- Study completion
- Sep 1996 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Steroids and intravenous immune globulin (IVIG).
- Documented HIV infection.
- Need for PCP prophylaxis.
- Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX).
- 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.
Key exclusion criteria (7 listed)
- Active PCP.
- Pancreatitis defined as amylase elevation associated with an elevated lipase that is > 2 x upper limit of normal.
- TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentamidine isethionate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Van Dyke R study chair
Pramberg J study chair
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pentamidine isethionate in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.