Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection

December 18, 2014 updated by: Bayer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SW10 9NH
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • California
      • Davis, California, United States, 95616
      • Los Angeles, California, United States, 90095
      • Palo Alto, California, United States, 94304-1207
      • San Francisco, California, United States, 94115
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Chicago, Illinois, United States, 60611-2908
    • Maryland
      • Bethesda, Maryland, United States, 20892
    • Ohio
      • Cleveland, Ohio, United States, 44106-2602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm 2
Drug: HAART
HAART alone
Experimental: Arm 1
Drug: Interleukin-2 SA
HAART and Bay 50-4798

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10630 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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