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| Sponsor: | MUC Research GmbH |
|---|---|
| Collaborators: |
Pfizer Merck Abbott |
| Information provided by (Responsible Party): | MUC Research GmbH |
| ClinicalTrials.gov Identifier: | NCT00908544 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: 2 NRTI + 1 PI/r + Maraviroc + Raltegravir |
| 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 |
| 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")
|
Drug: 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
Treatment initiation with multi drug class (MDC) HAART.
Other Names:
|
|
Experimental: CHI-patients
Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (see also "Eligibility")
|
Drug: 2 NRTI + 1 PI/r + Maraviroc + Raltegravir
Treatment intensification of PI-based HAART with Maraviroc and Raltegravir.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For all patients:
For chronically HIV-infected patients:
For patients with primary HIV infection:
Contacts and 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 | |
| University Munich University Hospital, Dept. of Infectious Diseases | |
| Munich, Bavaria, Germany, 80336 | |
| Private Practice Drs Pauli/Becker | |
| Munich, Bavaria, Germany, 80331 | |
| ICH Study Center | |
| Hamburg, Germany, 20354 | |
| Study Chair: | Hans Jaeger, MD | MUC Research GmbH |
| Study Chair: | Johannes Bogner, Prof., MD | University Munich, University Hospital, Dept. of Infectious Diseases, |
More Information
| Responsible Party: | MUC Research GmbH |
| ClinicalTrials.gov Identifier: | NCT00908544 History of Changes |
| Other Study ID Numbers: | MUC_NewEra_3.1, 2008-002070-35, 4034932, 08101, ID 8879, IISP #35576 |
| Study First Received: | May 26, 2009 |
| Last Updated: | September 22, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
HIV-infection Primary HIV-infection Proviral DNA Eradication Multi drug class HAART |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |