High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If
 sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a
 transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If
 autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a
 compatible donor is available. To minimize risk of transplant failure, a second unmodified
 CD34+ cell transplant will be given one week after the first transplant.
Inclusion Criteria:

 -  Male and female patients of any ethnic group aged between 18 and 65 years

 -  HIV-positive patients with malignant diseases of the blood (NHL, Hodgkin disease,
 plasmocytoma, acute and chronic leukaemia) who failed to achieve complete remission
 (CR) after standard-dose first-line chemotherapy or had a chemosensitive relapse after
 an initial CR

 -  Patients must receive HAART

 Exclusion Criteria:

 -  Any of the following conditions:

 -  congestive heart failure (NYHA > II)

 -  documented EBV, HBV or HCV infection (only for allogeneic PBSCT)

 -  creatinine clearance < 60 ml/min

 -  left ventricular ejection fraction < 40%

 -  bilirubin > 2 mg/dl

 -  Severe opportunistic infection

 -  More than 10% of bone marrow involved with lymphoma

 -  Between 2 and 5 10^6 autologous CD34+ cells/kg BW obtained after leukapheresis and
 CD34 enrichment

 -  Women of child.bearing potential not under adequate contraceptive protection

 -  Women who are pregnant or breast feeding

 -  Known history of drug-, medication- or alcohol abuse within the last 12 months
 preceding the study

 -  Participation in another study with an investigational product within less than one
 month prior to this study

 -  Simultaneous participation in a study with an investigational drug

 -  Presence of any disease likely to require procedures altering the schedule of the
 protocol

 -  Patients with a history of seizures, central nervous system disorders or psychiatric
 disability thought to be clinically significant in the opinion of the investigator

 -  Patients with limited mental capacity to the extent that he/she cannot provide
 informed consent or information regarding adverse events of the study medication

 -  Patients with any clinically meaningful renal, hepatic, respiratory or cardiovascular
 disease

 -  Patients who have previously been admitted to this study

 -  Patients who will not accept transfusions of blood products