HIV-1 Infection
Conditions
Keywords
HIV-1, CCR5 coreceptors, Maraviroc
Brief summary
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.
Interventions
DRUGMaraviroc
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
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients who give written consent to participate in the study * Age between 18 and 65 years old, included. * Chronic HIV-1 Demonstration of R5 viral tropism (use of CCR5 coreceptors) by genotyping in plasma samples stored * Patients that are to be treated with intensive chemotherapy for non Hodgkin lymphoma With or without stable antiretroviral therapy * Patients that are able to understand the purpose of the study and be available for scheduled appointments. * Both in the case of female and male patients, the patient agrees to use a double barrier method of contraception from the moment of signing the informed consent until 3 months after the end of their participation in the study.
Exclusion criteria
* To have planned antiretroviral treatment interruption during the participation in the study * Hypersensitivity to products used in this study * To be involved in another clinical trial or received an investigational drug within 3 months prior to the study initiation * To have contraindications or limitations to perform leukapheresis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM | Same as chemotherapy treatment (expected average of 6 months) | Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proviral DNA (copies/million cells) | Same as chemotherapy treatment (expected average of 6 months) | Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels |
| Effector T cells producing HIV-1 specific gamma interferon (cells/mm3) | Same as chemotherapy treatment (expected average of 6 months) | Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels |
| Levels of HIV-1 antibodies | Same as chemotherapy treatment (expected average of 6 months) | Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels |
| Percentage of CD4+ and CD8+ cells with immune activation markers | Same as chemotherapy treatment (expected average of 6 months) | Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels |
Countries
Spain
Outcome results
None listed