HIV InfectionsPhase 1NCT00002449
Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
A Phase 1 study testing Aldesleukin in people with HIV Infections, run by Chiron Corporation at 23 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give HIV-positive patients L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Aldesleukin
- How many people
- 212 participants
- Where
- 23 sitesUnited States
- Study dates
- Aug 1999to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a viral load below 10,000 copies/ml.
- Have a CD4 count between 300 and 500 cells/mm3.
- Have been on stable anti-HIV therapy for 4 months. Patients must be taking at least 2 drugs, 1 of which must be a protease inhibitor or a nonnucleoside drug (NNRTI).
- Are at least 18 years old.
- Agree to use an effective barrier method of birth control, such as condoms, during the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have an AIDS-defining illness. (Patients who have had an AIDS-defining illness that was cured may still be eligible.)
- Have an alcohol or drug abuse problem that the doctors feel would affect their ability to participate.
- Have cancer requiring chemotherapy.
- Have a history of autoimmune disease.
- Have uncontrolled diabetes or certain thyroid problems.
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- Have mental illness or other serious medical condition that the doctors feel would affect their ability to participate.
- Have received IL-2 in the past.
- Have taken corticosteroids or certain medications that affect the immune system in the past 4 weeks.
- Have taken hydroxyurea in the past 4 months.
- Are pregnant or breast-feeding.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Albany Med College
Albany, New York, 12208
Central Texas Clinical Research
Austin, Texas, 78705
Pacific Oaks Research
Beverly Hills, California, 90211
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203
Fenway Community Health Ctr
Boston, Massachusetts, 02115
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Northstar Med Clinic
Chicago, Illinois, 60657
Community AIDS Resource Inc
Coral Gables, Florida, 33146
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
Denver Inf Disease Consultants
Denver, Colorado, 80220
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
Gathe, Joseph, M.D.
Houston, Texas, 77004
Steinhart Medical Associates
Miami, Florida, 33133
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221
Research and Education Group
Portland, Oregon, 97210
Anderson Clinical Research Inc
Rego Park, New York, 11374
St Lukes Medical Group
San Diego, California, 92101
Kaiser Foundation Hospital
San Francisco, California, 94118
Virginia Mason Med Ctr
Seattle, Washington, 98101
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
About this study
Official title: A Bridging Dose-Escalation Study of the Safety, Pharmacokinetic Properties, and Immunologic Effect of Subcutaneous L2-7001 (Recombinant Human Interleukin-2) in Patients Infected With HIV With CD4+ T-Cell Counts of 300 to 500 Cells/mm3 and Viral Burden Under 10,000 Copies/Ml on Active Antiretroviral Therapy (ART)
The purpose of this study is to see if it is safe and effective to give HIV-positive patients L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. IL-2 may be able to boost the immune systems of people with HIV infection.
Read the detailed description
This study takes place in two phases. Phase A consists of an open-label dose-escalation of L2-7001 through four dose levels. Ascending dose cohorts of five patients are studied. The safety and tolerability of L2-7001 is assessed in preparation for the second phase of the study and to estimate an MTD. Phase B involves randomization of 190 patients to (a) one of three dose levels of L2-7001 plus ART, (b) one of two dosing levels of Proleukin plus ART, or (c) ART alone. L2-7001 and Proleukin are given SC every 12 hours for the first 5 days of an 8-week cycle for three cycles. Serum IL-2 levels, soluble IL-2 receptor levels, and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of Phase B. All patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to L2-7001.
- Conditions
- HIV Infections
- Being tested
- Aldesleukin
- Keywords
- Recombinant Proteins, Injections, Subcutaneous, Interleukin-2, Dose-Response Relationship, Drug, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, 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.
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 startAug 1999
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.
- 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
- 212 participants
Sponsor and investigators
- Lead sponsor
- Chiron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002449
- Sponsor's protocol ID
- B007
- Other IDs
- CS-MM-9901
- Status last verified
- Jul 2001
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bridging Dose-Escalation Study of the Safety, Pharmacokinetic Properties, and Immunologic Effect of Subcutaneous L2-7001 (Recombinant Human Interleukin-2) in Patients Infected With HIV With CD4+ T-Cell Counts of 300 to 500 Cells/mm3 and Viral Burden Under 10,000 Copies/Ml on Active Antiretroviral Therapy (ART)
- ClinicalTrials.gov ID
- NCT00002449
- Acronym / sponsor ID
- B007
- Conditions
- HIV Infections
- Keywords
- Recombinant Proteins, Injections, Subcutaneous, Interleukin-2, Dose-Response Relationship, Drug, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants
- Lead sponsor
- Chiron CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- 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 it is safe and effective to give HIV-positive patients L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. IL-2 may be able to boost the immune systems of people with HIV infection.
Detailed description
This study takes place in two phases. Phase A consists of an open-label dose-escalation of L2-7001 through four dose levels. Ascending dose cohorts of five patients are studied. The safety and tolerability of L2-7001 is assessed in preparation for the second phase of the study and to estimate an MTD. Phase B involves randomization of 190 patients to (a) one of three dose levels of L2-7001 plus ART, (b) one of two dosing levels of Proleukin plus ART, or (c) ART alone. L2-7001 and Proleukin are given SC every 12 hours for the first 5 days of an 8-week cycle for three cycles. Serum IL-2 levels, soluble IL-2 receptor levels, and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of Phase B. All patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to L2-7001.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have a viral load below 10,000 copies/ml.
- Have a CD4 count between 300 and 500 cells/mm3.
- Have been on stable anti-HIV therapy for 4 months. Patients must be taking at least 2 drugs, 1 of which must be a protease inhibitor or a nonnucleoside drug (NNRTI).
- Are at least 18 years old.
Key exclusion criteria (11 listed)
- Have an AIDS-defining illness. (Patients who have had an AIDS-defining illness that was cured may still be eligible.)
- Have an alcohol or drug abuse problem that the doctors feel would affect their ability to participate.
- Have cancer requiring chemotherapy.
- Have a history of autoimmune disease.
- Have uncontrolled diabetes or certain thyroid problems.
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 |
|---|---|---|
| Aldesleukin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 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 Aldesleukin in people with HIV Infections, run by Chiron Corporation at 23 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Results are not available in the source record.
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 24 Jun 2005.