HIV-infected patients will be treated with a highly active antiretroviral treatment trying to eradicate the HI-Virus.

Phase 1

Conditions: Human immuno-deficiency virus [HIV] disease
MedDRA version: 17.1Level: LLTClassification code 10020160Term: HIV diseaseSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2008-002070-35-DE

Lead Sponsor: MUC Research GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

FOR Stratum I (PHI) only
N=20 patients with primary HIV infection:
?Detectable plasma viral load
?Elisa positive or negative and Western Blot negative or positive with ? 2 bands at screening visit;
?no primary resistance to PI´s and NRTI´s

FOR Stratum II (CHR) only
N= 20 patients with chronically HIN infection:
?Chronically HIV-infected patients with a plasma VL < 50 copies/ml for >=36 months under continuous PI-based HAART (blips not allowed) and without preceding virological failure
?Current HAART exists of 2 NRTI plus 1 PI

FOR ALL PATIENTS
?Age =18 years.
?For women of reproductive potential negative serum or urine pregnancy test within 48 hours prior to initiating study medications.
?Use of reliable method of contraception while receiving the protocol-specified treatment and for 6 weeks thereafter.
?For males and their female sexual partners use of acceptable methods of birth control during the entire study.
?CCR5-tropic HI-virus

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Evidence for drug intolerability
?Documented HIV-1 resistance to PI and/or NRTI.
?CD4 nadir <200/µl
?CHR: 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:
a.Hemoglobin < 8 mg/dL
b.Neutrophil count < 750 cells/?L
c.Platelet count < 50,000 cells/L
d.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 Entry-Inhibitor.
?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).