New Era Study: Treatment With Multi Drug Class (MDC) HAART in HIV Infected Patients (NewEra)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
AbbVie
Pfizer
Information provided by (Responsible Party):
MUC Research GmbH
ClinicalTrials.gov Identifier:
NCT00908544
First received: May 26, 2009
Last updated: April 14, 2015
Last verified: April 2015
  Purpose

This is a multi-center, open-label, non-randomized proof-of-concept trial. Two cooperating HIV-specialized centres represented by Dr. med. Hans Jaeger and Prof. Dr. Johannes Bogner are planning to perform an IIT (investigator initiated trial) with the goal to eradicate HIV in N=40 HIV-infected patients with either primary infection or chronic infection and successful HAART (Highly Active Antiretroviral Treatment) of several years.

All patients will be started on a multi-drug HAART including two Nucleoside-Reverse-Transcriptase-Inhibitors (NRTI´s), one Protease-Inhibitor (PI), a CCR5-inhibitor and an Integrase-Inhibitor (INI). Decay of viral reservoirs like latently HIV-infected CD4+ T-cells will be monitored over time.


Condition Intervention
HIV Infections
Other: PHI-patients
Other: CHI-patients

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NEW ERA STUDY - HIV and Eradication: A Multicenter, Open-label, Non-randomized Trial to Evaluate Treatment With Multi-drug Class (MDC) HAART and Its Impact on the Decay Rate of Latently Infected CD4+ T Cells Incl. Amendment 1.0

Resource links provided by NLM:


Further study details as provided by MUC Research GmbH:

Primary Outcome Measures:
  • Cell-associated proviral DNA: infectious units per 10exp6 PBMC (peripheral blood mononuclear cells) and per 10exp6 CD4 cells [ Time Frame: Screening, pre-baseline (only for CHI-patients), baseline, months 1, 3, 6 and then every 6 months until month 84, plus 3 post-follow-up visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma HIV RNA (using standard and single copy assays) [ Time Frame: Screening, pre-baseline (only for CHI-patients), baseline, months 1, 3, 6 and then every 6 months until month 84, plus 3 post-follow-up visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PHI-patients
Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
Other: PHI-patients
Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
Experimental: CHI-patients
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also "Eligibility") intensified by Maraviroc + Raltegravir
Other: CHI-patients
Treatment intensification of PI-based HAART with Maraviroc and Raltegravir. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion Criteria:

    For all patients:

    • HIV-infected patient
    • Age greater 18 years
    • No acute AIDS-defining disease or history of AIDS- defining disease
    • CD4-cell nadir above or equal 200 cells/µL
    • Hemoglobin greater 8 g/dl
    • Neutrophil count greater 750 cells/µL
    • Platelet count greater 50.000 cells/µL
    • AST/ALT below 5x upper limit of normal range
    • No evidence for drug intolerability
    • No prior use of an HIV integrase inhibitor or CCR5 antagonist
    • No presence of malignancy (requiring active treatment and malignancy within 5 years prior to enrolment (even if in complete remission)
    • No significant underlying disease (non-HIV) that might impinge upon disease progression or death
    • No history of alcohol or other substance abuse or other condition which in the opinion of the investigator would interfere with the patient compliance or safety.
    • Written informed consent
    • For males and premenopausal females use of acceptable methods of birth control during the entire study and for 6 weeks thereafter
    • No pregnancy (for premenopausal women: negative serum or urine pregnancy test within 48 hours prior to initiating study medications)
    • No breastfeeding

    For chronically HIV-infected patients (CHI):

    • Continuous plasma viral load below 50 copies/ml for the preceding 36 months under HAART (two or less single viral load blips up to 500 copies/ml are allowed)
    • Stable HAART (for at least 3 months) prior to the Screening visit consisting of 2 NRTI + 1 PI
    • No history of virological failure
    • No documented resistance to PI and NRTI
    • CCR5-tropic virus

    For patients with primary HIV infection (PHI):

    • Detectable plasma viral load
    • ELISA positive or negative and Western Blot negative or positive with less or equal 2 bands at screening visit
    • No primary resistance to PI´s and NRTI´s
    • CCR5-tropic virus
  2. Exclusion criteria:

Evidence for drug intolerability or contraindication concerning any drug foreseen for MDC HAART

  • Documented HIV-1 resistance to PI and/or NRTI.
  • CD4 nadir <200/µL
  • Acute AIDS-defining disease or history of AIDS-defining disease
  • CHI: preceding virological failure
  • History of alcohol or other substance abuse or other condition which in the opinion of the investigator would interfere with the patient compliance or safety.
  • Any of the following abnormal laboratory test results in screening:

    1. Hemoglobin < 8 g/dL
    2. Neutrophil count < 750 cells/µL
    3. Platelet count < 50,000 cells/µL
    4. AST or ALT > 5x the upper limit of normal
  • Presence of malignancy (requiring active treatment and malignancy within 5 years prior to enrolment (even if in complete remission)
  • Significant underlying disease (non-HIV) that might impinge upon disease progression or death
  • Prior use of any experimental HIV- Integrase-Inhibitor or CCR5-antagonist.
  • Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).
  • Contraindications for Maraviroc (Celsentri®) or Raltegravir (Isentress®) according to the respective summary of product characteristics (see also product informations attached to the protocol) (Hypersensitivity to the active substances or any of the excipients).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908544

Locations
Germany
Onkology Karlsruhe
Karlsruhe, Baden-Wuerttemberg, Germany, 76135
Private Practice for Internal Medicine, Hematology and Oncology
Mannheim, Baden-Wuerttemberg, Germany, 68161
Private Practice Drs Ulmer/Frietsch/Mueller
Stuttgart, Baden-Wuerttemberg, Germany, 70197
Practice Dr. med. Lothar Schneider
Fürth, Bavaria, Germany, 90762
MUC Research
Munich, Bavaria, Germany, 80335
Private Practice Drs Pauli/Becker
Munich, Bavaria, Germany, 80331
University Munich University Hospital, Dept. of Infectious Diseases
Munich, Bavaria, Germany, 80336
ICH Study Center
Hamburg, Germany, 20354
Sponsors and Collaborators
MUC Research GmbH
Merck Sharp & Dohme Corp.
AbbVie
Pfizer
Investigators
Study Chair: Hans Jaeger, MD MUC Research GmbH
Study Chair: Johannes Bogner, Prof., MD University Munich, University Hospital, Dept. of Infectious Diseases,
  More Information

No publications provided

Responsible Party: MUC Research GmbH
ClinicalTrials.gov Identifier: NCT00908544     History of Changes
Other Study ID Numbers: MUC_NewEra_3.3, 2008-002070-35, 4034932, 08101, ID 8879, IISP #35576
Study First Received: May 26, 2009
Last Updated: April 14, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by MUC Research GmbH:
HIV-infection
Primary HIV-infection
Proviral DNA
Eradication
Multi drug class HAART

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on June 30, 2015