HIV InfectionsPhase 1NCT00006066
Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems
A Phase 1 study testing Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Diphtheria and Tetanus Toxoids Adsorbed and Tetanus and Diphtheria Toxoids Adsorbed in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Diphtheria and Tetanus Toxoids Adsorbed and Tetanus and Diphtheria Toxoids Adsorbed
- Type of treatment
- Vaccines
- How many people
- 92 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Start not givento Jun 2006
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A child may be eligible for this trial if he/she:
- Is HIV-positive.
- Is 2 to 18 years old (consent of parent or guardian required if under 18).
- Has received 12 or more weeks of anti-HIV drug therapy, consisting of at least 3 drugs. This combination may include a nucleoside reverse transcriptase inhibitor (NRTI), a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or 3 NRTIs. Combinations of NRTIs may not include abacavir (ABC). Patients may have taken ABC if it was not in combination with 2 other NRTIs. (This reflects a change in the requirement for anti-HIV therapy.)
- Has a plasma HIV RNA level of less than 10,000 copies/ml.
- Has evidence of a weakened immune system (based on CD4 cell counts and absolute CD4 percentage less than 25 percent). (This reflects a change in how a weakened immune system is defined.)
- Has a parent or guardian who is willing to comply with study requirements.
- Has symptoms of HIV infection.
Who cannot join
- A child will not be eligible for this study if he/she:
- Has an active opportunistic (AIDS-related) infection.
- Is pregnant.
- Is taking certain medications, such as steroids or other drugs that affect the immune system, within 6 weeks prior to study entry.
- Is taking ABC.
- Is taking certain antibodies.
- (Exclusion criteria reflect changes.)
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 021155724
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801
Usc La Nichd Crs
Los Angeles, California, 90033
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 701122699
Nyu Ny Nichd Crs
New York, New York, 10016
Columbia IMPAACT CRS
New York, New York, 10032
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California
UCSF Pediatric AIDS CRS
San Francisco, California, 941430105
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210
USF - Tampa NICHD CRS
Tampa, Florida, 33701
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20010-2970
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20060
Puerto Rico1 site
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 009365067
About this study
Official title: Phase I/II Trial of Subcutaneous IL-2 With Highly Active Antiretroviral Therapy in HIV-Infected Children With Immunosuppression
The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children.
IL-2 is an important substance produced by the body's white blood cells that helps the body fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection. It has not been studied very much in children and doctors need to know what doses are safe to give.
Read the detailed description
One of the challenges in effective combination therapy in HIV-infected patients is the ability to achieve immune reconstitution. IL-2 is hypothesized to restore and/or preserve the immune system when added to potent antiretroviral regimens. This study will evaluate restoration of immune functions of CD4 cells and will also determine the best way to deliver IL-2 in a safe and effective way.
Part I: Patients add a 5-day course of subcutaneous IL-2 every 8 weeks for up to 48 weeks (6 cycles) to their HAART therapy. Three dose levels of IL-2 are administered. [AS PER AMENDMENT 5/3/01: It is strongly recommended, but not required, that] the first and second cycles of IL-2 are given in the hospital on an inpatient basis. The parent or patient is trained to give the injections and has the option of administering subsequent injections at home. Patients are monitored for CD4 and CD8 cell count and viral load. Enrollment into Part 1 begins at the lowest dose level; assuming no serious toxicities (Grade 3 or higher) occur, patients are enrolled into higher dose levels. The highest tolerated dose is established.
Part 2: After the highest tolerated dose is established in Part 1, additional patients are randomized to receive HAART alone (Arm 1), HAART with high-dose IL-2 (Arm 2), or HAART with low-dose IL-2 (Arm 3). High-dose IL-2 is given twice daily at the highest dose tolerated in Part 1 for 5 days every 8 weeks for 6 cycles. Low-dose IL-2 is given once a day every day for 48 weeks. For Arms 2 and 3 [AS PER AMENDMENT 5/3/01: (except patients in the pharmacokinetic substudy), it is strongly recommended, but not required, that] IL-2 is given the first week on an inpatient basis by hospital personnel. As in Part 1, there is the option of administering the remaining injections at home. Intensive toxicity monitoring, routine lymphocyte subsets, and quantitative HIV RNA are performed on all patients at specified time points during the study. The first 12 patients in Arms 2 and 3 have pharmacokinetic testing with frequent blood samples drawn at intervals, some of which require staying up to 12 hours at the clinic. Diphtheria/tetanus immunizations and bacteriophage phi X174 immunizations are administered to all patients to determine antibody responses.
- Conditions
- HIV Infections
- Being tested
- Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Diphtheria and Tetanus Toxoids Adsorbed, Tetanus and Diphtheria Toxoids Adsorbed, Bacteriophage phi X 174, Aldesleukin
- Keywords
- Injections, Subcutaneous, Interleukin-2, Dose-Response Relationship, Drug, Drug Therapy, Combination, Immunocompromised Host, CD4 Lymphocyte Count, Anti-HIV Agents
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedBiological
Diphtheria and Tetanus Toxoids AdsorbedBiological
Tetanus and Diphtheria Toxoids AdsorbedBiological
Bacteriophage phi X 174Drug
AldesleukinDrug
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 completionJun 2006
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
- 92 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
- Savita Pahwa, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006066
- Sponsor's protocol ID
- ACTG 402
- Other IDs
- 10607, PACTG 402
- Status last verified
- Oct 2021
- First submitted
- 14 Jul 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
- Phase I/II Trial of Subcutaneous IL-2 With Highly Active Antiretroviral Therapy in HIV-Infected Children With Immunosuppression
- ClinicalTrials.gov ID
- NCT00006066
- Acronym / sponsor ID
- ACTG 402
- Conditions
- HIV Infections
- Keywords
- Injections, Subcutaneous, Interleukin-2, Dose-Response Relationship, Drug, Drug Therapy, Combination, Immunocompromised Host, CD4 Lymphocyte Count, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 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
- Jun 2006 (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 determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children.
IL-2 is an important substance produced by the body's white blood cells that helps the body fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection. It has not been studied very much in children and doctors need to know what doses are safe to give.
Detailed description
One of the challenges in effective combination therapy in HIV-infected patients is the ability to achieve immune reconstitution. IL-2 is hypothesized to restore and/or preserve the immune system when added to potent antiretroviral regimens. This study will evaluate restoration of immune functions of CD4 cells and will also determine the best way to deliver IL-2 in a safe and effective way.
Part I: Patients add a 5-day course of subcutaneous IL-2 every 8 weeks for up to 48 weeks (6 cycles) to their HAART therapy. Three dose levels of IL-2 are administered. [AS PER AMENDMENT 5/3/01: It is strongly recommended, but not required, that] the first and second cycles of IL-2 are given in the hospital on an inpatient basis. The parent or patient is trained to give the injections and has the option of administering subsequent injections at home. Patients are monitored for CD4 and CD8 cell count and viral load. Enrollment into Part 1 begins at the lowest dose level; assuming no serious toxicities (Grade 3 or higher) occur, patients are enrolled into higher dose levels. The highest tolerated dose is established.
Part 2: After the highest tolerated dose is established in Part 1, additional patients are randomized to receive HAART alone (Arm 1), HAART with high-dose IL-2 (Arm 2), or HAART with low-dose IL-2 (Arm 3). High-dose IL-2 is given twice daily at the highest dose tolerated in Part 1 for 5 days every 8 weeks for 6 cycles. Low-dose IL-2 is given once a day every day for 48 weeks. For Arms 2 and 3 [AS PER AMENDMENT 5/3/01: (except patients in the pharmacokinetic substudy), it is strongly recommended, but not required, that] IL-2 is given the first week on an inpatient basis by hospital personnel. As in Part 1, there is the option of administering the remaining injections at home. Intensive toxicity monitoring, routine lymphocyte subsets, and quantitative HIV RNA are performed on all patients at specified time points during the study. The first 12 patients in Arms 2 and 3 have pharmacokinetic testing with frequent blood samples drawn at intervals, some of which require staying up to 12 hours at the clinic. Diphtheria/tetanus immunizations and bacteriophage phi X174 immunizations are administered to all patients to determine antibody responses.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Is HIV-positive.
- Is 2 to 18 years old (consent of parent or guardian required if under 18).
- Has received 12 or more weeks of anti-HIV drug therapy, consisting of at least 3 drugs. This combination may include a nucleoside reverse transcriptase inhibitor (NRTI), a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or 3 NRTIs. Combinations of NRTIs may not include abacavir (ABC). Patients may have taken ABC if it was not in combination with 2 other NRTIs. (This reflects a change in the requirement for anti-HIV therapy.)
- Has a plasma HIV RNA level of less than 10,000 copies/ml.
- Has evidence of a weakened immune system (based on CD4 cell counts and absolute CD4 percentage less than 25 percent). (This reflects a change in how a weakened immune system is defined.)
Key exclusion criteria (7 listed)
- Has an active opportunistic (AIDS-related) infection.
- Is pregnant.
- Is taking certain medications, such as steroids or other drugs that affect the immune system, within 6 weeks prior to study entry.
- Is taking ABC.
- Is taking certain antibodies.
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 |
|---|---|---|
| Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | Biological | – |
| Diphtheria and Tetanus Toxoids Adsorbed | Biological | – |
| Tetanus and Diphtheria Toxoids Adsorbed | Biological | – |
| Bacteriophage phi X 174 | Drug | – |
| Aldesleukin | 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.
Savita Pahwa study chair
14 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 Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Diphtheria and Tetanus Toxoids Adsorbed and Tetanus and Diphtheria Toxoids Adsorbed in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 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 8 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 14 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.