Clinical trial NCT00562510 (phase 3, status: terminated)
Conditions: hiv infections
ICD codes: Z21
Drugs: raltegravir, placebo
SMILES: CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    recruitment lower than estimated
  
Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 infection.

          -  Subject has voluntarily signed and dated an informed consent form.

          -  Documented sustained HIV RNA < 50 copies/ml (two consecutive pVL < 50 copies/ml, first
             VL > 12 months before the screening date) without documentation of HIV RNA > 50
             copies/ml for at least 12 months while on previous stable HAART (PS_HAART).

          -  HIV RNA < 50 copies/ml at screening.

          -  Subject is currently receiving an antiretroviral regimen which has not changed for at
             least 12 months.

          -  CD4 count < 200 cells/ mm3 AND CD4 increase < 100 cells/ mm3 in the last 12 months.

          -  Subject's vital signs, physical examination and laboratory results do not exhibit
             evidence of acute illness.

          -  Negative serum or urine pregnancy test and willing to use acceptable means of
             contraception.

        Exclusion Criteria:

          -  Patient is receiving tenofovir DF AND didanosine as a component of the background
             antiretroviral therapy.

          -  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)>2.5 x upper limit of normal (ULN) AND/OR is likely to require
             treatment in the next year.

          -  Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic,
             metabolic, or hepatic disease or any condition that, in the investigators opinion,
             could compromise the subject's safety or adherence to the trial protocol.

          -  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
             enrolled.

          -  Life expectancy < 1 year according to the judgment of the investigator.

          -  Screening laboratory analysis show any of the following abnormal laboratory results:

               -  Hemoglobin < 8.0 g/dL

               -  Absolute neutrophil count < 750 cells/µL

               -  Platelet count < 50,000 mm3

          -  Use of any investigational agents within 30 days prior to screening.

          -  Previous use of integrase inhibitors.

          -  Use of immunosuppressive drugs, cytokine inhibitors or other cytokines in the last
             year.

          -  Continuous use of systemic corticoids for more than a month in the last year or any
             use in the last 3 months.

          -  Subject has an ongoing history of substance abuse or psychiatric illness.

          -  Subject is pregnant or breast-feeding.