MARCH

A comparison of the switch groups with the control group with regard to the percentage of participants with HIV-RNA <200 copies/mL 48 weeks after randomisation.

• Percentage of patients with HIV-1-RNA<50 copies/mL in plasma
• Duration until virologic failure (defined as HIV-1-RNA≥200 copies/mL in plasma during randomised therapy and in two cases with at least seven days distance)
• Duration until loss of virologic reaction as defined according to virologic failure, i.e. a permanent randomised interruption of treatment, a new AIDS-defining illness, death or withdrawal from the study.
• Deviation from the basic value in log HIV-1 RNA copies/mL in plasma
• Frequency of HIV-1 RNA increase blips in plasma (defined as virus load result in the plasma of >200 copies/mL combined with a randomised therapy after a previous result of <200 copies/mL followed by a result of <200 copies/mL at least seven days after the measured value of >200 copies/mL without any change in any component of the ART regime).

1. HIV-1 infection verified by a licensed diagnosis test at a time before acceptance into the study.
2. Age > 18 years
3. HIV-1 RNA <200 copies/mL in plasma for at least 24 weeks
4. Stable (>24 weeks) ART therapy with two N(t)RTIs and one PI/r
5. No signs of primary genotypic mutations of the reverse transcriptase or the protease of the HIV for all patients with prior results from resistance tests conducted before the cART and/or during the viral rebound/failure.
6. Written declaration of informed consent.

1. CXCR4 or CCR5/CXCR4 dualtrope HIV tropism or non-reportable tropism result based on analyses with pro-viral DNA.
2. Expected need of modification of the current cART regimen for toxicity management during the next 6 months.
3. The following lab criteria:
   1. Absolute quantity of neutrophils (ANC) < 750 cells/µL
   2. Haemoglobin < 8.0 g/dL
   3. Platelet quantity <50,000 cells/µL
   4. AST, ALT in serum >5 x maximum limit of normal range
4. Active hepatitis B co-infection
5. Pregnant woman or breast-feeding mother
6. Current use of any prohibited medication as described in the product-specific information
7. Hypersensitivity against soy or peanuts
8. Current therapy due to a severe infection or other severe medical conditions (based on the assessment of the chief investigator at the institution) which necessitate a systemic treatment and/or acceptance into hospital.
9. Use of immune system modulators (e.g. systemic corticosteroids, recombinant interleukin-2, interferon) within a period of 30 days before screening
10. Patients who currently consume alcohol or illegal substances which would, in the opinion of the chief investigator, disagree with any aspect of the study
11. Patients who are extremely unlikely to be able to complete the follow-up examinations for the period defined in the protocol

Prison inmates or persons under mandatory detention (involuntary incarcerated). 

Maraviroc Tbl.