Clinical trial NCT00460382 (phase 2, status: completed)
Conditions: hiv infections
ICD codes: Z21
Drugs: raltegravir potassium, darunavir/ritonavir, etravirine, optimized background regimen
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Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18 years and above

          -  Documented HIV-1 infection.

          -  History of virological failure on NNRTIs (patients with a history of toxicity to
             nevirapine and efavirenz may be enrolled in this study).

          -  On a combination antiretroviral therapy for at least 8 weeks prior to the screening
             visit (if on tipranavir, or enfuvirtide these drugs should have been introduced more
             than 8 weeks before the screening visit).

          -  Patient naive to darunavir, etravirine and to integrase inhibitors

          -  Plasma viral load at screening visit over 1000 copies/ml, (no CD4 restriction).

          -  Genotypic resistance testing at the screening visit:

               -  Protease inhibitor mutations: over or equal to 3 primary protease inhibitor
                  mutations among: D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, I54M, L76V,
                  V82A/F/L/T/S, I84V, N88S and L90M (IAS list 2006) but below or equal to 3
                  mutations among the following: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, L76V,
                  I84V et L89V (virus sensitivity to darunavir/ritonavir).

               -  Reverse transcriptase mutations: over or equal to 3 NRTI mutations (among IAS
                  list) and below or equal to 3 mutations among: A98G, L100I, K101Q/P/E,
                  K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179D/E/F/G/I, Y181C/I/V/C/H/L,
                  Y188C/H/L, G190A/C/E/Q/S, P225H, F227C/L, M230I/L, P236L, K238N/T and Y318F
                  (virus sensitivity to etravirine)

        Exclusion Criteria:

          -  Non effective barrier contraception in women of child bearing potential

          -  Pregnant women or women who are breastfeeding

          -  Opportunistic infection at the acute phase

          -  Decompensated cirrhosis (stage B or C of Child-Pugh score)

          -  Malignancy requiring chemotherapy or radiotherapy

          -  Contraindicated medications being taken by the patient (listed in protocol)

          -  Allergy to the active substances and expedients of darunavir, etravirine and
             raltegravir.

          -  Haemoglobin < 7g/dl, neutrophil cell count < 500/mm3, platelets < 50,000/mm3,
             creatinine clearance < 50 ml/mn, P. alkaline, AST, ALT or total bilirubin over or
             equal to 3 times normal values.

          -  Patients receiving experimental agents with an exclusion period for participation in
             other studies applicable at the screening visit of the current study.