... / ... / ... / Research & development / HIV / multicentre trials

HIV / multicentre trials

projecten m.b.t. HIV en HIV co-infecties, deelname aan diverse trials en studies

HIV and HIV co-infections

 

HIV & Sexually Transmitted Diseases:

incidence of sexually transmitted diseases among HIV-positive men who have sex with men (financial support RIVM, CiB)

 

Hepatitis B/HIV co-infection

  • prospective, randomized, open study to evaluate the efficacy of a short (4 weeks) and a long (6 months) course HBV vaccination scheme in HIV positive patients
  • double-dosage HBV booster vaccination in HIV positive patients failing normal HBV vaccination
  • efficacy of lamivudine/tenofovir for the treatment of HIV-HBV co-infected patients in the Netherlands
  • determinants of non-response after influenza vaccination in HIV infected patients

 

HIV/HPV study

in collaboration with the department of dermatology, study to evaluate the efficacy of photodynamic therapy in AIN II and III in HIV positive MSM is being performed (ROANCO study)

 

HIV vaccination study

in close collaboration with the department of Virology a study into the efficacy of  therapeutic HIV vaccination is currently running

  

Intracellular assessment of intracellular viral druglevels

In collaboration with Virology and Pediatrics we perform a study on intracellular drug levels of antivirals. Plasma drug levels so far have not been helpful in predicting viral response. Antiretroviral drugs are partly metabolized intracellular and act intracellular. The intracellular assessment of drugs is very complex. This project could facilitate a PhD project.

 

HIV-2 study

In Rotterdam 40 HIV-2 infected patients are being in follow up. This small population already served 1 PhD project and several international publications. At this moment we coordinate and assess the efficacy and safety of 2 new antiretrovirals in HIV-2 infected patients in the Netherlands.

 

 

participation in various multicentre trials

 

PRIMO study

prospective, randomized study on the efficacy of no treatment, 6 month or 18 months of HAART in primary HIV infection

 

HIV-Host Genetics study

to determine whether genetic makeup is associated with the natural course of HIV infection

 

MAN2 study

randomized study to assess the safety and efficacy of MMF (cellcept) in asymptomatic patients, not on HAART

 

BITE study

randomized, placebo controlled study to assess the efficacy of nutrional supplements on the CD4 cell count in asymptomatic naïve patients

 

DUET trial

Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial

 

Maraviroc study

this study observes the efficacy and safety of a new class of antiretroviral drugs: a CCR5 receptor inhibitor

 

TITAN study

Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients

 

TMC278

a phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects

 
TMC125 early access program

 

Furthermore, we participate in several studies on pharmacokinetics with David Burger, from Nijmegen, such as kinetics during pregnancy, kinetics in antiretrovirals and anti-malaria drugs, etc.