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New Era HIV Studie


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

Status: Active

Purpose / Objectives

Primary Outcome

The primary objective of this trial is to reduce proviral DNA in PBMC and thereby achieve HIV eradication using multi-drug class HAART (MDC HAART*) in patients with primary HIV infection and in successfully treated chronically HIV-infected patients after an overall treatment period of at least 5 years including multi-drug HAART for at least 2 years.

Secondary Outcomes

- to provide good estimates of the latently infected reservoir size (infectious copies/10exp6 PBMC (= peripheral blood mononuclear cells) and infectious copies/10exp6 resting CD4+ T cells) and

 - to evaluate the decay rates of latently infected CD4+ T cells both in patients with primary HIV-infection treated with MDC HAART* and in antiretrovirally treated chronically HIV-infected patients before and after intensification of HAART


patients with primary HIV infection and patients with chronically HIV infection

Target population


A - C



Inclusion criteria

FOR Stratum I (PHI) only

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

 patients with chronically HIV infection:

  • Chronically HIV-infected patients with a plasma VL < 50 copies/ml for >=36 months under continuous PI-based HAART (≤2 single viral load blips <500 cop./ml allowed) and without preceding virological failure
  • Current HAART exists of 2 NRTI plus 1 PI


  • 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 adequate, acceptable (highly effective) methods for birth control and prevention of HIV transmission during the entire study.
  • CCR5-tropic HI-virus

-       CAVE for PHI stratum:

Patients will have to start treatment within 2 weeks after blood sampling for HIV test; If resistance testing and/or tropism testing are not available at the time of treatment initiation, treatment should be adapted in case of dual mixed (D/M) tropic or CXCR4-tropic virus at the discretion of the treating physician. In this case, the patient will be discontinued from the study.

  • Written informed consent



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


Study design

  • Phase III
  • Multicenter
  • Two-arm
  • Open Label



PHI group


CHI group


Documents (password protected)

Responsibilities in overall study