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

• 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 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).