Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and controlled clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Patients randomized to experimental control will start Maraviroc treatment before, during and after chemotherapy until lymphocytes level recovery. Maraviroc Dose: 300 mg/12 hours For patients receiving an HIV-protease inhibitor (except tipranavir or Fosamprenavir), the dose will be reduced to 150 mg/12hours For patients receiving Efavirenz dose the dose will be 600 mg/12hours
Hospital Universitario Ramon Y Cajal
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM
Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Proviral DNA (copies/million cells)
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Levels of HIV-1 antibodies
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Time frame: Same as chemotherapy treatment (expected average of 6 months)
Percentage of CD4+ and CD8+ cells with immune activation markers
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
Time frame: Same as chemotherapy treatment (expected average of 6 months)
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