HIV InfectionsPhase 1NCT00006325
Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
A Phase 1 study testing Peginterferon alfa-2b in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
Trial summary
The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood). Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Peginterferon alfa-2b
- How many people
- 54 participants
- Where
- 15 sitesUnited States
- Study dates
- Start not givento Mar 2004
- 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 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-infected infants and children aged 3 months to 16 years.
- Have been on stable anti-HIV drugs for at least 16 weeks if over 6 months of age. Infants aged 3 to 6 months must be on stable anti-HIV drugs for at least 6 weeks. Children should be receiving at least 3 anti-HIV drugs.
- Have a viral load of more than 5,000 copies/ml.
- Have written informed consent from parent or guardian and, if able, can give written consent themselves.
- Are able to follow the schedule in the protocol.
- Have a parent/guardian who is willing to comply with study requirements.
- (This study has been changed to allow any combination of 3 anti-HIV drugs and to remove CD4 requirements.)
Who cannot join
- Patients will not be eligible for this study if they:
- Are breast-feeding or pregnant or not using birth control, if a female.
- Have abnormal thyroid activity.
- Have severe HIV symptoms.
- Have opportunistic (AIDS-related) infections or history of such infections within the preceding 2 months.
- Have participated in a clinical trial of an experimental drug in the previous month.
Show all 10Show fewer
- Have a positive test result for hepatitis B or C.
- Have an allergy to E. coli.
- Have a mental disorder.
- Have a history of drug dependence and measure positive when screened.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Univ of Miami (Pediatric)
Miami, Florida, 33161
Schneider Children's Hosp
New Hyde Park, New York, 11040
Harlem Hosp Ctr
New York, New York, 10037
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
About this study
Official title: Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of PEG-Intron in HIV-1 Infected Children
The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood).
PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)
Read the detailed description
The current optimal clinical management of HIV infection involves therapy with combinations of nucleoside and nonnucleoside reverse transcriptase inhibitors and HIV protease inhibitors. These regimens, though effective, do not completely eliminate HIV and the development of drug resistance is a major clinical problem. Interferons have been proposed as a possible treatment of HIV. Interferon-alfa inhibits HIV replication in vitro, and HIV-infected patients appear to have reduced production of interferons. Previous short-term clinical studies in adults showed anti-HIV activity, although there were safety and tolerability problems associated with the higher dose regimens used. This study will utilize a rising multiple-dose design to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PEG-Intron in HIV-infected children.
In a dose-escalation study, patients add weekly PEG-Intron to their antiretroviral therapy for up to 6 weeks. The first 2 doses are received in the clinic where parents/guardians are trained to administer injections, and succeeding doses are given at home.
Patients are enrolled from 2 cohorts. An older cohort of ages 2 to 16 years receives PEG-Intron at the lowest drug level. If the dose is tolerated, patients are added and if safety criteria are met, patients are enrolled in the next higher dose level. The dose level will be increased similarly for up to 4 doses. An optimal dose level is chosen.
Cohort II patients are a younger group ranging from 3 months to under 2 years of age. Patients initially receive the next lower PEG-Intron dose to the optimal dose identified in Cohort I [AS PER AMENDMENT 07/23/01: or 1 microg/kg if the optimal dose proves to be 1 microg/kg]. If this dose is safely tolerated, additional patients are added. If this dose level meets safety criteria, patients are enrolled to receive the optimal dose level. Patients are evaluated with the same safety criteria as Cohort I. Patients in both cohorts who have at least a 0.5 log reduction in HIV RNA at 28 days of treatment are offered continued treatment for a total of 60 weeks.
- Conditions
- HIV Infections
- Being tested
- Peginterferon alfa-2b
- Keywords
- Polyethylene Glycols, Interferon Alfa-2b, HIV-1, Dose-Response Relationship, Drug, Drug Therapy, Combination, Virus Inhibitors, Anti-HIV Agents, Pharmacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2bDrug
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 completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 54 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Katherine Luzuriaga, Study chairAndrea Kovacs, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006325
- Sponsor's protocol ID
- P1017
- Other IDs
- PACTG P1017, ACTG P1017, 11652
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2000
- 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
- Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of PEG-Intron in HIV-1 Infected Children
- ClinicalTrials.gov ID
- NCT00006325
- Acronym / sponsor ID
- P1017
- Conditions
- HIV Infections
- Keywords
- Polyethylene Glycols, Interferon Alfa-2b, HIV-1, Dose-Response Relationship, Drug, Drug Therapy, Combination, Virus Inhibitors, Anti-HIV Agents, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Mar 2004 (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.
The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood).
PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)
Detailed description
The current optimal clinical management of HIV infection involves therapy with combinations of nucleoside and nonnucleoside reverse transcriptase inhibitors and HIV protease inhibitors. These regimens, though effective, do not completely eliminate HIV and the development of drug resistance is a major clinical problem. Interferons have been proposed as a possible treatment of HIV. Interferon-alfa inhibits HIV replication in vitro, and HIV-infected patients appear to have reduced production of interferons. Previous short-term clinical studies in adults showed anti-HIV activity, although there were safety and tolerability problems associated with the higher dose regimens used. This study will utilize a rising multiple-dose design to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PEG-Intron in HIV-infected children.
In a dose-escalation study, patients add weekly PEG-Intron to their antiretroviral therapy for up to 6 weeks. The first 2 doses are received in the clinic where parents/guardians are trained to administer injections, and succeeding doses are given at home.
Patients are enrolled from 2 cohorts. An older cohort of ages 2 to 16 years receives PEG-Intron at the lowest drug level. If the dose is tolerated, patients are added and if safety criteria are met, patients are enrolled in the next higher dose level. The dose level will be increased similarly for up to 4 doses. An optimal dose level is chosen.
Cohort II patients are a younger group ranging from 3 months to under 2 years of age. Patients initially receive the next lower PEG-Intron dose to the optimal dose identified in Cohort I [AS PER AMENDMENT 07/23/01: or 1 microg/kg if the optimal dose proves to be 1 microg/kg]. If this dose is safely tolerated, additional patients are added. If this dose level meets safety criteria, patients are enrolled to receive the optimal dose level. Patients are evaluated with the same safety criteria as Cohort I. Patients in both cohorts who have at least a 0.5 log reduction in HIV RNA at 28 days of treatment are offered continued treatment for a total of 60 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Are HIV-infected infants and children aged 3 months to 16 years.
- Have been on stable anti-HIV drugs for at least 16 weeks if over 6 months of age. Infants aged 3 to 6 months must be on stable anti-HIV drugs for at least 6 weeks. Children should be receiving at least 3 anti-HIV drugs.
- Have a viral load of more than 5,000 copies/ml.
- Have written informed consent from parent or guardian and, if able, can give written consent themselves.
- Are able to follow the schedule in the protocol.
Key exclusion criteria (10 listed)
- Are breast-feeding or pregnant or not using birth control, if a female.
- Have abnormal thyroid activity.
- Have severe HIV symptoms.
- Have opportunistic (AIDS-related) infections or history of such infections within the preceding 2 months.
- Have participated in a clinical trial of an experimental drug in the previous month.
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 |
|---|---|---|
| Peginterferon alfa-2b | 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.
Katherine Luzuriaga study chair
Andrea Kovacs study chair
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peginterferon alfa-2b in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
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 8 inclusion and 10 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 15 sites in United States. 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.