Clinical trial NCT02273765 (phase 3, status: completed)
Conditions: hiv-1 infection, tuberculosis
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4, A18.39, P37.0, Z22.7, A15.0, A15.7, A15.8, A15.9
Drugs: tenofovir + lamivudine + raltegravir, tenofovir + lamivudine + efavirenz
SMILES: [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C, [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form

          -  Aged 18 years or more

          -  Confirmed HIV-1 infection as documented at any time prior to trial entry per national
             HIV testing procedures

          -  ART naïve

          -  For women of childbearing potential i.e. women of childbearing age who are not
             menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral
             salpingectomy) or not refraining from sexual activity: negative urinary test for
             pregnancy and acceptance to use contraceptive methods

          -  Confirmed or probable active TB disease of any location, except neurological
             (meningitis or encephalitis), according to the following criteria based on WHO updated
             definitions:

               -  Bacteriologically confirmed pulmonary TB (PTB) or extrapulmonary TB (EPTB), e.g.
                  TB with a biological specimen positive by smear microscopy, culture or nucleic
                  acid amplification test (such as Xpert MTB/RIF).

               -  Clinically diagnosed PTB or EPTB with typical histological evidence of TB
                  (caseous or granulomatous) on biopsy specimen or positive urinary LAM test OR a
                  significant improvement on TB treatment

          -  Ongoing standard rifampin-containing TB treatment for ≤8 weeks at inclusion

          -  For French patients, affiliation to a Social Security program

        Exclusion Criteria:

          -  HIV-2 co-infection

          -  Impaired hepatic function (icterus or ALT (SGPT) > 5ULN)

          -  Hemoglobin < 6.5 g/dl

          -  Creatinine clearance <60ml/min (assessed by the Cockroft and Gault formula)

          -  Mycobacterium tuberculosis strain resistant to rifampin (current or past history).

          -  Neurological TB (meningitis or encephalitis)

          -  Severe associated diseases requiring specific treatment (including all specific AIDS
             defining illnesses other than TB, and any severe sepsis)

          -  Any condition which might, in the investigator's opinion, compromise the safety of
             treatment and/or patient's adherence to trial procedures including very severe
             TB-related clinical condition

          -  Concomitant treatments including phenytoin or phenobarbital (compounds interacting
             with UGT1A1)

          -  For HCV co-infected patients, need to start specific treatment for hepatitis during
             the trial duration

          -  For women of childbearing potential:

               -  Pregnancy or breastfeeding

               -  Refusal to use a contraceptive method

               -  Any history of ARV intake for prevention of mother to child transmission of HIV
                  (pMTCT)

          -  Subjects participating in another clinical trial evaluating therapies and including an
             exclusion period that is still in force during the screening phase

          -  Person under guardianship, or deprived of freedom by a judicial or administrative
             decision