ABOUT THIS STUDY
1. Male or female subject is at least 21 years of age.
2. Patient with documented HIV-1 infection defined as a positive ELISA plus a confirmatory Western Blot; or alternatively, a plasma HIV- RNA ≥10,000 copies/ml ever documented.
3. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
4. Subject agrees not to take any medication during the study, including over the counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs without the approval of the trial physician.
5. Documented HIV RNA >500 copies/ml
6. Subject triple class antiretroviral failure (NRTI, NNRTI, PI)
7. Subject naïve to CCR5-inhibitors, integrase-inhibitors and darunavir.
8. Subjects can comply with protocol requirements.
9. Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial.
10. If female, subject must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she must:
1. use of a double birth control method that includes at least one barrier method, that is acceptable to both the subject and investigator, and
2. has a urine pregnancy test performed at the Screening Visit and on Baseline, and results of both tests must be negative.
3. continue practicing birth control methods for at least 30 days after the end of the treatment period.
11. Subject present R5 HIV1 at Screening, verified by Trofile Essay by Monogram Bioscience.
1. Evidence of resistance against Maraviroc, Raltegravir, Darunavir/Ritonavir, based on
the resistance test performed at Screening.
2. Previously documented HIV-2 infection.
3. Use of disallowed concomitant therapy listed in guidelines for use of each drug.
4. Patient has a current (active) diagnosis of acute hepatitis due to any cause OR
chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine
aminotransferase (ALT)>5 x upper limit of normal (ULN) AND/OR is likely to require
treatment in the next year.
5. Any active clinically significant disease (e.g. tuberculosis, cardiac disfunction,
pancreatitis) or findings during screening of medical history or physical examination
that, in the investigator´s opinion, would compromise the subject´s safety or outcome
of the trial or adherence to the trial protocol.
6. Subject has a currently active AIDS defining illness (Category C conditions according
to the CDC Classification System for HIV infection 1993) within 30 days of screening.
Subjects who are on stable maintenance therapy for an opportunistic infection may be
7. Life expectancy < 1 year according to the judgment of the investigator.
8. Screening laboratory analysis show any of the following abnormal laboratory results:
1. Hemoglobin < 8.0 g/dL
2. Absolute neutrophil count < 750 cells/µL
3. Platelet count < 50,000 mm3
9. Subject enrolled in other clinical trials that include any blood sampling, specimen
collection, or other interventional procedure. Concurrent participation in
non-interventional observational trials
10. Use of any investigational agents within 30 days prior to screening.
11. Use of immunosuppressive drugs, cytokine inhibitors or other cytokines in the last
12. Any condition (including but not limited to alcohol and drug use) which in the opinion
of the investigator, could compromise the subject's safety or adherence to the
13. Subject is pregnant or breast-feeding
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