HIV-infected patients
Conditions
Interventions
Trade Name: CELSENTRI
Pharmaceutical Form: Gastro-resistant capsule
INN or Proposed INN: MARAVIROC
CAS Number: 376348-65-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
FIBio Hospital Universitario Ramón y Cajal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study. ? Aged over 18 years. ? Understanding the objective of the study and being available to make frequent visits to the hospital. ? Negative pregnancy test done in the 7 days prior to the commencement of the study treatment in premenopausal women or =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Pregnancy or intention to become pregnant during the study, as well as being in a period of lactation. ? Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded. ? Proven resistance against the antiretroviral drugs under study. ? Planned interruption of antiretroviral therapy. ? Taking immunosuppressive or immunostimulating medication of any type, including valproic acid. ? Taking a fusion inhibitor (enfuvirtide)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if treatment with MVC during a short period of time in patients with previously suppressed viral load by antiretroviral treatment leads to an increase in transcription of latent virus;Secondary Objective: To determine the intracellular signalling pathways by which the activation of the transcription of latent virus occurs;Primary end point(s): Quantification of cytoplasmic forms of viral HIV-1 RNA (usRNA and msRNA) measured before and after treatment with MVC;Timepoint(s) of evaluation of this end point: Baseline and days 1, 3 and 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Identification of the main intracellular signaling pathways involved in the transcriptional activation of HIV-1;Timepoint(s) of evaluation of this end point: Baseline and days 1, 3, 10 and 28 | — |
Countries
Spain
Contacts
Public ContactDR MORENO GUILLEN
FIBio Hospital Universitario Ramón y Cajal
Outcome results
None listed