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: March 25, 2014
Last verified: March 2014

May 26, 2009
March 25, 2014
May 2009
November 2018   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00908544 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
New Era Study: Treatment With Multi Drug Class (MDC) HAART in HIV Infected Patients
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

The purpose of this study is to decrease viral reservoirs in N=40 HIV-infected patients with either primary infection or chronic infection and successful HAART for at least three years. All patients will be started on a multi drug HAART including two NRTI, one PI, a CCR5-inhibitor and an integrase inhibitor. Decay of viral reservoirs like latently HIV-infected CD4+ T-cells will be monitored over time.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
    Treatment initiation with multi drug class (MDC) HAART.
    Other Names:
    • Celsentri
    • Isentress
  • Drug: 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
    Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
    Other Names:
    • Celsentri
    • Isentress
  • Experimental: PHI-patients
    Patients with primary HIV infection (PHI) (see also "Eligibility") are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
    Intervention: Drug: 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
    Intervention: Drug: 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
November 2019
November 2018   (final data collection date for primary outcome measure)

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/microliter
  • Hemoglobin greater 8 g/dl
  • Neutrophil count greater 750 cells/microliter
  • Platelet count greater 50.000 cells/microliter
  • 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:

  • 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:

  • 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00908544
MUC_NewEra_3.1, 2008-002070-35, 4034932, 08101, ID 8879, IISP #35576
Yes
MUC Research GmbH
MUC Research GmbH
  • Merck Sharp & Dohme Corp.
  • AbbVie
  • Pfizer
Study Chair: Hans Jaeger, MD MUC Research GmbH
Study Chair: Johannes Bogner, Prof., MD University Munich, University Hospital, Dept. of Infectious Diseases,
MUC Research GmbH
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP