Maraviroc (CCR5) Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory S… (NCT00988780) | Clinical Trial Compass
UnknownNot Applicable
Maraviroc (CCR5) Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients
United States, Mexico276 participantsStarted 2009-12
Plain-language summary
The purpose of this study is to determine if Maraviroc administration can decrease IRIS incidence in HIV infected patients initiating ARV therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* HIV-1 infection, as documented by any licensed rapid test kit and confirmed by Western blot or ELISA test kit at any time prior to study enrollment.
Plasma HIV-1 RNA is acceptable as an alternative confirmatory test.
* Men and women age \> 18 years.
* Have not received any antiretroviral treatment before entering the study.
* Patients who received Single dose nevirapine or any duration of AZT for PMTC will not be considered ARV naïve.
* CD4+ cell count of \</=100 cells/mm3 obtained within 90 days prior to study entry.
* HIV RNA level \> 1,000 copies/mL obtained within 90 days prior to study entry.
* Patients with an opportunistic or HIV-related infection may be included according to the clinical judgment of the main investigator in each center when the patient is ready and able to start ARV therapy.
* Laboratory values obtained within 30 days prior to study entry:
* Absolute neutrophil count (ANC) \> 500/mm3.
* Hemoglobin \> 8.0 g/dL.
* Platelet count \> 50,000/mm3.
* AST (SGOT), ALT (SGPT), and alkaline phosphatase minor of 5 times ULN.
* Total bilirubin minor of 2.5 times ULN.
* Creatinine clearance minor of 50\* mL/min as estimated by the Cockcroft-Gault equation or Creatinine Clearance \> 50ml/min as calculated by a formal creatinine clearance measurement
* All women of reproductive potential (have not reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) must have a negative serum or urine b-HCG pregnancy test…
What they're measuring
1
Time to occurrence of an IRIS event
Timeframe: The initial 24 week period of observation
Trial details
NCT IDNCT00988780
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran