As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

New Era HIV Studie

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
MUC_NewEra_3.12008-002070-3525.04.2009

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

Diagnosis

patients with primary HIV infection and patients with chronically HIV infection

Target population

Stage

A - C

Age

18-99

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

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 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

Intervention

 

PHI group

2 NRTI + PI + MVC + RAL (MDC HAART)

CHI group

Existing HAART + MVC + RAL (MDC HAART)

Documents (password protected)

Responsibilities in overall study