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New Era HIV Studie

Overall study
Study Sites (1)

Acronym	ISRCTN	EudraCT	NCT (clinicaltrials.gov)	DRKS
MUC_NewEra_3.1

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

HIV-1

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)

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