Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children

HIV Infections Clinical Trial

Official title:

Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of PEG-Intron in HIV-1 Infected Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006325
• Other study ID #: P1017
• Secondary ID: PACTG P1017ACTG
• Status: Completed
• Phase: Phase 1
• Est. completion date: March 2004

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 16 Years

Eligibility

Inclusion Criteria

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.)

Exclusion Criteria

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.

• 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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Peginterferon alfa-2b

Locations

Country	Name	City	State
United States	Children's Hosp of Boston	Boston	Massachusetts
United States	Connecticut Children's Med Ctr	Farmington	Connecticut
United States	Texas Children's Hosp / Baylor Univ	Houston	Texas
United States	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida
United States	Long Beach Memorial (Pediatric)	Long Beach	California
United States	Children's Hosp of Los Angeles/UCLA Med Ctr	Los Angeles	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Univ of Miami (Pediatric)	Miami	Florida
United States	Schneider Children's Hosp	New Hyde Park	New York
United States	Harlem Hosp Ctr	New York	New York
United States	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey
United States	UCSF / Moffitt Hosp - Pediatric	San Francisco	California
United States	Baystate Med Ctr of Springfield	Springfield	Massachusetts
United States	SUNY Health Sciences Ctr at Syracuse / Pediatrics	Syracuse	New York
United States	Univ of Massachusetts Med School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

External Links

•   Haga clic aquí para ver información sobre este ensayo clínico en español.