Status:
UNKNOWN
Maraviroc (CCR5) Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborating Sponsors:
University of Witwatersrand, South Africa
Case Western Reserve University
Conditions:
Immune Reconstitution Inflammatory Syndrome
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if Maraviroc administration can decrease IRIS incidence in HIV infected patients initiating ARV therapy.
Detailed Description
This is a randomized, double blind, placebo-controlled, multicenter study testing the utility of a CCR5 antagonist (Maraviroc) as an adjuvant to a standard HAART regimen to decrease the incidence of I...
Eligibility Criteria
Inclusion
- 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 performed within 7 days before study entry.
- Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) or whose male partner has undergone successful vasectomy with resultant azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Documentation of menopause, sterilization (hysterectomy, oophorectomy, tubal ligation, or vasectomy) and azoospermia by patient-reported history is acceptable.
- All subjects must agree not to participate in a conception process (i.e., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female study volunteer/male partner must agree to use a form of contraception as specified in the note below while receiving protocol-specified medication(s) and for one month after stopping the medication(s).
- Ability and willingness of subject or legal guardian/representative to give written informed consent.
Exclusion
- Pregnancy and breast-feeding.
- Active neoplasia or previous history of neoplasia. (Except localized non visceral Kaposi´s Sarcoma; localized squamous or basal cell carcinoma of the skin, or intraepithelial cervical neoplasia grade III or less).
- Use of the following drugs within 180 days prior to study entry: systemic cancer chemotherapy, systemic investigational agents, and immunomodulators (growth factors, immune globulin, interleukins, interferons).
- Use of systemic corticosteroids in the last 2 weeks prior to randomization.
- Decompensated liver disease (defined as stage C of Child-Pugh classification) at the beginning of the study.
- An altered mental status that in the opinion of the investigator, will compromise the adherence to the protocol.
- Allergy/sensitivity to study drug(s) or their formulations that cannot be substituted by another agent as described in section 5.1
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Serious illness that renders a subject unable to take the antiretroviral study regimen.
- Serious medical illness that in the opinion of the investigator compromises the adherence and/or follow up of the protocol.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00988780
Start Date
December 1 2009
End Date
April 1 2013
Last Update
November 27 2012
Active Locations (10)
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1
NIH/NIAD
Bethesda, Maryland, United States, 20892
2
Center for AIDS Research. Case Western Reserve University
Cleveland, Ohio, United States, 44106
3
Center for Clinical Epidemiology and Biostatistics. University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
4
HIV-1 Immunopathogenesis Laboratory. The Wistar Institute
Philadelphia, Pennsylvania, United States, 19104