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| Sponsor: | MUC Research GmbH |
|---|---|
| Collaborators: |
Pfizer Merck Abbott |
| Information provided by: | 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| 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 2016 |
| Estimated Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
PHI-patients: Experimental
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.
|
|
CHI-patients: Experimental
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.
|
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| Contact: Hans Jaeger, MD | +49(0)89 558 703-0 | info@jajaprax.de |
| Contact: Johannes Bogner, Prof., MD | +49 (0)89 5160 -3550 ext -3598 | johannes.bogner@med.uni-muenchen.de |
| Germany | |
| MUC Research | Recruiting |
| Munich, Germany, 80335 | |
| Contact: Hans Jaeger, MD +4989558703 ext 0 info@jajaprax.de | |
| Contact: Eva Wolf, MPH., Dipl. Phys. +4989558703 ext 0 ewo@mucresearch.de | |
| Principal Investigator: Hans Jaeger, MD | |
| University Munich University Hospital, Dept. of Infectious Diseases | Recruiting |
| Munich, Germany, 80336 | |
| Contact: Johannes Bogner, Prof., MD +49 (0)89 5160 355 ext 0 johannes.bogner@med.uni-muenchen.de | |
| Principal Investigator: Johannes Bogner, Prof., MD | |
| 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 ( Hans Jaeger, MD, Coordinating Investigator ) |
| Study ID Numbers: | MUC_NewEra_3.1, 2008-002070-35, BfArM 4034932, EK 08101, ID 8879, IISP #35576 |
| Study First Received: | May 26, 2009 |
| Last Updated: | July 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00908544 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
HIV-infection Primary HIV-infection Proviral DNA Eradication Multi drug class HAART |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |