HIV InfectionsPhase 3NCT00000949
A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3
A Phase 3 study testing Aldesleukin 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 examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV. 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
- 460 participants
- Where
- 15 sitesUnited States
- Study dates
- Start not givento Jul 2000
- Phase
- Phase 3
- 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
- You may be eligible for this study if you:
- Are HIV-positive.
- Agree to practice abstinence or use effective birth control methods during the study.
- Are on anti-HIV therapy and have a CD4 count of at least 300 cells/mm3.
- Are at least 18 years old.
Who cannot join
- You will not be eligible for this study if you:
- Have a history of progressive diseases.
- Have a history of severe autoimmune/inflammatory disease.
- Have Crohn's disease.
- Are taking antiseizure medications or certain other medications.
- Are receiving chemotherapy.
- Are pregnant or breast-feeding.
- Have ever received rIL-2.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
The Research and Education Group
Portland, Oregon, 97210
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 23298
Community Consortium / UCSF
San Francisco, California, 94110
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
About this study
Official title: A Randomized, Open-Label, Study of the Impact of Two Doses of Subcutaneous Recombinant IL-2 (Proleukin) on Viral Burden and CD4+ Cell Count in Patients With HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm3
The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV.
There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden).
Read the detailed description
There is substantial evidence that rIL-2 increases CD4+ cell count. Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown, such clinical benefits of rIL-2 can only be established in a large, long-term, randomized trial. This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of rIL-2.
Patients are randomized to receive one of two subcutaneous (sc) doses of recombinant rIL-2 or no rIL-2. Those patients who take rIL-2 initially receive three courses of treatment. For this study, a course is defined as eight calendar weeks, including the five-day period of sc rIL-2 administration. Additional courses are given (no more frequently than every 6 weeks) in order to maintain a CD4+ count of at least twice its baseline level or at least 1,000 cells/mm3. Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient.
- Conditions
- HIV Infections
- Being tested
- Aldesleukin
- Keywords
- AIDS-Related Opportunistic Infections, Interleukin-2, Dose-Response Relationship, Drug, Adolescent Behavior, CD4 Lymphocyte Count, RNA, Viral, Quality of Life, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections, AIDS-Related Opportunistic Infections, Adolescent Behavior
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 completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 460 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Donald I. Abrams, Study chairNorman Markowitz, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000949
- Sponsor's protocol ID
- CPCRA 059
- Other IDs
- 11615
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Publications
Abrams DI, Bebchuk JD, Denning ET, Davey RT, Fox L, Lane HC, Sampson J, Verheggen R, Zeh D, Markowitz NP; Terry Beirn Community Programs for Clinical Research on AIDS. Randomized, open-label study of the impact of two doses of subcutaneous recombinant interleukin-2 on viral burden in patients with HIV-1 infection and CD4+ cell counts of > or = 300/mm3: CPCRA 059. J Acquir Immune Defic Syndr. 2002 Mar 1;29(3):221-31. doi: 10.1097/00126334-200203010-00002.
PubMed 11873071
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Study of the Impact of Two Doses of Subcutaneous Recombinant IL-2 (Proleukin) on Viral Burden and CD4+ Cell Count in Patients With HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm3
- ClinicalTrials.gov ID
- NCT00000949
- Acronym / sponsor ID
- CPCRA 059
- Conditions
- HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Interleukin-2, Dose-Response Relationship, Drug, Adolescent Behavior, CD4 Lymphocyte Count, RNA, Viral, Quality of Life, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jul 2000 (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 examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV.
There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden).
Detailed description
There is substantial evidence that rIL-2 increases CD4+ cell count. Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown, such clinical benefits of rIL-2 can only be established in a large, long-term, randomized trial. This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of rIL-2.
Patients are randomized to receive one of two subcutaneous (sc) doses of recombinant rIL-2 or no rIL-2. Those patients who take rIL-2 initially receive three courses of treatment. For this study, a course is defined as eight calendar weeks, including the five-day period of sc rIL-2 administration. Additional courses are given (no more frequently than every 6 weeks) in order to maintain a CD4+ count of at least twice its baseline level or at least 1,000 cells/mm3. Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV-positive.
- Agree to practice abstinence or use effective birth control methods during the study.
- Are on anti-HIV therapy and have a CD4 count of at least 300 cells/mm3.
- Are at least 18 years old.
Key exclusion criteria (8 listed)
- Have a history of progressive diseases.
- Have a history of severe autoimmune/inflammatory disease.
- Have Crohn's disease.
- Are taking antiseizure medications or certain other medications.
- Are receiving chemotherapy.
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
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 29 Oct 2021.
- Background: PubMed 11873071Abrams DI, Bebchuk JD, Denning ET, Davey RT, Fox L, Lane HC, Sampson J, Verheggen R, Zeh D, Markowitz NP; Terry Beirn Community Programs for Clinical Research on AIDS. Randomized, open-label study of the impact of two doses of subcutaneous recombinant interleukin-2 on viral burden in patients with HIV-1 infection and CD4+ cell counts of > or = 300/mm3: CPCRA 059. J Acquir Immune Defic Syndr. 2002 Mar 1;29(3):221-31. doi: 10.1097/00126334-200203010-00002.
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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.
Donald I. Abrams study chair
Norman Markowitz 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 3 study testing Aldesleukin 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 5 inclusion and 8 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 29 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
On the ClinicalTrials.gov record for NCT00000949, which also lists 1 linked publication.
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 29 Oct 2021.