Human immuno-deficiency virus [HIV] disease MedDRA version: 17.1 Level: LLT Classification code 10020160 Term: HIV disease System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Isentress
Pharmaceutical Form: Tablet
INN or Proposed INN: Raltegravir
CAS Number: 518048-05-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Tra
Sponsors
MUC Research GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =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
Exclusion criteria: ? Evidence for drug intolerability ? Documented HIV-1 resistance to PI and/or NRTI. ? CD4 nadir 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to 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. *Eradication (Annotation see Protocol Version 3.3 page 13) is defined as: 1. Plasma VL 1000 copies/ml (measurements should be at least two weeks apart). • For PHI: a) Confirmed persisting plasma viral load 6 months (> 50 copies/ml) after HAART initiation (measurements should be at least two weeks apart) or b) Confirmed virologic rebound in plasma viral load to levels >1000 copies/ml (measurements should be at least two weeks apart) Eradication is defined as 1. Plasma VL < 50 copies/ml for at least 5 years and 2. Undetectable plasma viral load (HIV RNA < 1 copy/ml, 1-copy assay) for at least 2 years and 3. Undetectable proviral DNA in PBMC for at least 2 years ;Timepoint(s) of evaluation of this end point: At completion of month 36 visit for all study participants and at end of trial; Criteria for reaching an endpoint will be continuously monitored during the course of the trials. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany
Contacts
Public ContactMUC Research
MUC Research GmbH
Outcome results
None listed