Status:
COMPLETED
New Era Study: Treatment With Multi Drug Class (MDC) HAART in HIV Infected Patients
Lead Sponsor:
MUC Research GmbH
Collaborating Sponsors:
Merck Sharp & Dohme LLC
AbbVie
Conditions:
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 per...
Detailed Description
1\. Recruitment and Treatment: Recruitment will be stratified according to stage of HIV-infection and pre-treatment: * Stratum I (PHI patients): Patients presenting with primary HIV infection * St...
Eligibility Criteria
Inclusion
- 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
- 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:
- Hemoglobin \< 8 g/dL
- Neutrophil count \< 750 cells/µL
- Platelet count \< 50,000 cells/µL
- 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).
Exclusion
Key Trial Info
Start Date :
May 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00908544
Start Date
May 15 2009
End Date
May 1 2018
Last Update
August 28 2019
Active Locations (8)
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1
Onkology Karlsruhe
Karlsruhe, Baden-Wurttemberg, Germany, 76135
2
Private Practice for Internal Medicine, Hematology and Oncology
Mannheim, Baden-Wurttemberg, Germany, 68161
3
Private Practice Drs Ulmer/Frietsch/Mueller
Stuttgart, Baden-Wurttemberg, Germany, 70197
4
Practice Dr. med. Lothar Schneider
Fürth, Bavaria, Germany, 90762