HIV InfectionsPhase 1/2NCT00059462
Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection
A Phase 1/2 study testing Interleukin-2 SA and HAART in people with HIV Infections, run by Bayer at 11 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell count. 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?
- Interleukin-2 SA and HAART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Dec 2002to Mar 2005
- Phase
- Phase 1/2
- 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
- Documented HIV infection (positive enzyme linked immuno assay (EIA) confirmed by Western Blot).
- Age greater than or equal to 18 years.
- Plasma HIV viral load less than 10,000 copies/ml (by bDNA assay or less than 14,000 copies/ml by RT-PCR) on at least 2 occasions within 8 weeks prior to study entry with no more than a 0.5 log increase between the most recent and the earlier viral load measurements.
- CD4 + T-cell count greater than or equal to 200/mm(3) on at least 2 occasions within 8 weeks of study entry.
- On a stable HAART regimen for greater than or equal to 8 weeks.
- Karnofsky Score greater than or equal to 80.
Show all 26Show fewer
- Written informed consent. Exclusion Criteria:
- Prior treatment with IL-2 or an IL-2 analogue.
- Pregnancy or breastfeeding. - Use of any known immunomodulators, cytokines, growth factors or systemic corticosteroids (e.g. prednisone greater than or equal to 15 mg/day or equivalent) within 4 weeks prior to study enrollment.
- History of an AIDS defining illness by the Centers for Disease Control (CDC) definition within 8 weeks prior to study entry.
- Acute bacterial or viral infection within 4 weeks prior to enrollment.
- Received an immunization within 4 weeks prior to enrollment.
- History of autoimmune disease including psoriasis, inflammatory bowel disease.
- Medical history of transplantation (solid organ or bone marrow).
- Received an investigational drug in the past 30 days other than Food and Drug Administration (FDA) sanctioned treatment IND antiretroviral agents.
- Renal insufficiency with a serum creatinine level greater than 1.5 times the upper limit of normal.
- Bone marrow suppression as defined by one or more of the following: granulocyte count less than 1,000 cells/µL; hemoglobin less than 9.0g (females) or less than 9.5g (males); or platelet count less than 75,000 cells/µL.
- Evidence of hepatic disease indicated by one or more of the following: SGOT (AST) and/or SGPT (ALT) greater than 5 times the upper limit of normal. Bilirubin greater than 2 times the upper limit of normal (except for patients with known Gilbert's syndrome or those receiving indinavir who may be enrolled if the serum bilirubin is less than or equal to 5 times the upper limit of normal).
- Active cardiac disease (coronary artery disease, congestive heart failure or cardiomyopathy) requiring treatment with any of the following medications: antiarrhythmic agents including digitalis, anti-anginal drugs including topical or systemic nitrates, calcium channel blockers, and beta blockers, and afterload reducers including ACE inhibitors. Patients requiring any of these medications solely for the treatment of hypertension remain eligible for the study.
- Presence of significant cardiac insufficiency (greater than or equal to New York Heart Association Grade 2).
- Diagnosis of an active malignancy requiring treatment with systemic cytotoxic chemotherapy.
- Active alcohol or substance abuse which, in the opinion of the investigator, will seriously compromise the subject's ability to adhere with the demands of the study.
- Any central nervous system (CNS) disease that requires active treatment with anticonvulsants.
- Use of an antimetabolite such as hydroxyurea within 4 weeks prior to study entry.
- Known co-infection with Hepatitis B or C virus unless serum transaminases are less than or equal to 2 times the upper limit of normal on at least two occasions within 8 weeks prior to study entry.
- Known CD4 Nadir less than 50 cells/mm(3).
Who cannot join
None listed.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States9 sites
Study site
Bethesda, Maryland, 20892
Study site
Birmingham, Alabama, 35294
Study site
Chicago, Illinois, 60611-2908
Study site
Chicago, Illinois, 60612
Study site
Cleveland, Ohio, 44106-2602
Study site
Davis, California, 95616
Study site
Los Angeles, California, 90095
Study site
Palo Alto, California, 94304-1207
Study site
San Francisco, California, 94115
About this study
Official title: Phase I/II Randomized, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Bay 50-4798 Administration in Patients With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to Patients on HAART Alone.
The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell count.
- Conditions
- HIV Infections
- Being tested
- Interleukin-2 SA, HAART
- Keywords
- Treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2 SADrug
HAART and Bay 50-4798
HAARTDrug
HAART alone
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Interleukin-2 SA |
| Arm 2 | Active comparator | Not described Receives: Drug: HAART |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2003 (estimated)
- Study startDec 2002
- Primary completionMar 2005
- Study completionMar 2005
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 BayerThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059462
- Sponsor's protocol ID
- 10630
- Status last verified
- Dec 2014
- First submitted
- 25 Apr 2003
- Last updated
- 23 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Randomized, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Bay 50-4798 Administration in Patients With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to Patients on HAART Alone.
- ClinicalTrials.gov ID
- NCT00059462
- Acronym / sponsor ID
- 10630
- Conditions
- HIV Infections
- Keywords
- Treatment experienced
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 2 Jun 2003 (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 evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell count.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Interleukin-2 SA |
| Arm 2 | Active comparator | Drug: HAART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Documented HIV infection (positive enzyme linked immuno assay (EIA) confirmed by Western Blot).
- Age greater than or equal to 18 years.
- Plasma HIV viral load less than 10,000 copies/ml (by bDNA assay or less than 14,000 copies/ml by RT-PCR) on at least 2 occasions within 8 weeks prior to study entry with no more than a 0.5 log increase between the most recent and the earlier viral load measurements.
- CD4 + T-cell count greater than or equal to 200/mm(3) on at least 2 occasions within 8 weeks of study entry.
- On a stable HAART regimen for greater than or equal to 8 weeks.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Interleukin-2 SAHAART and Bay 50-4798 | Drug | Arm 1 |
| HAARTHAART alone | Drug | Arm 2 |
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 23 Dec 2014.
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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.
Bayer Study Director study director
Bayer
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Interleukin-2 SA and HAART in people with HIV Infections, run by Bayer at 11 sites in 3 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 26 inclusion and 0 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, France, United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Dec 2014.