kinetics of hiv-rna decay in seminal plasma of men treated by dolutegravir at the time of primary hiv infection

Conditions: HIV Infection Primary

Summary: sponsor: imea - fondation internationale léon mba c.h.u. bichat - claude bernard 46, rue henri huchard - 75018 paris tél. : 01.40. 25. 63. 65 - fax : 01.40.25.63.56 coordinating investigator: dr caroline lascoux combe hôpital saint louis service maladies infectieuses 1 avenue claude vellefaux - 75010 paris tél. : 01 42 49 49 73 - fax : 01 42 49 47 43 e-mail : caroline.lascoux-combe@aphp.fr participating country : france primary objective : comparing the kinetic of hiv-rna decay in blood plasma and in seminal plasma in patients starting a triple combination regimen with dolutegravir + tenofovir df (tdf) + emtricitabine (ftc) at the time of phi. secondary objectives : * comparison of hiv-1 rna level in plasma (threshold 20 and 1 copies/ml) and in seminal plasma (threshold 60 copies/ml) at each visit d0, w2, w4, w8, w12, w24, w36, w48 * to assess the frequency of intermittent shedding in seminal plasma once virological suppression has been achieved and until w48 * evolution of cellular hiv-1 dna level in pbmc and in non-sperm cells between d0 and w48 * comparison of dolutegravir concentration in blood plasma and seminal plasma * study of risk factors associated with viral persistence of hiv-rna in the seminal plasma * analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved (i.e. at d0 and w12) inclusion criteria : * patients diagnosed at the time of primary hiv infection (phi) (i) a negative or indeterminate hiv elisa associated with a positive antigenemia or plasma hiv rna, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for hiv antibodies followed within 3 months by a positive hiv serology * treatment including dolutegravir (dtg 50mg) + tenofovir/emtricitabine (tdf/ftc 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of phi * genotypic sensitivity to tdf, ftc and dtg * patient with medical care insurance exclusion criteria : * chronic infection * infection or co-infection with hiv-2 study treatment : dolutegravir and tenofovir/emtricitabine number of subjets : 20 patients (exploratory study)

secondary objectives : * comparison of hiv-1 rna level in plasma (threshold 20 and 1 copies/ml) and in seminal plasma (threshold 60 copies/ml) at each visit d0, w2, w4, w8, w12, w24, w36, w48 * to assess the frequency of intermittent shedding in seminal plasma once virological suppression has been achieved and until w48 * evolution of cellular hiv-1 dna level in pbmc and in non-sperm cells between d0 and w48 * comparison of dolutegravir concentration in blood plasma and seminal plasma * study of risk factors associated with viral persistence of hiv-rna in the seminal plasma * analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved (i.e. at d0 and w12) inclusion criteria : * patients diagnosed at the time of primary hiv infection (phi) (i) a negative or indeterminate hiv elisa associated with a positive antigenemia or plasma hiv rna, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for hiv antibodies followed within 3 months by a positive hiv serology * treatment including dolutegravir (dtg 50mg) + tenofovir/emtricitabine (tdf/ftc 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of phi * genotypic sensitivity to tdf, ftc and dtg * patient with medical care insurance exclusion criteria : * chronic infection * infection or co-infection with hiv-2 study treatment : dolutegravir and tenofovir/emtricitabine number of subjets : 20 patients (exploratory study)

Eligibility criteria:
inclusion criteria: * patients diagnosed at the time of primary hiv infection (phi) (i) a negative or indeterminate hiv elisa associated with a positive antigenemia or plasma hiv rna, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for hiv antibodies followed within 3 months by a positive hiv serology * treatment including dolutegravir (dtg 50mg) + tenofovir/emtricitabine (tdf/ftc 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of phi * genotypic sensitivity to tdf, ftc and dtg * patient with medical care insurance exclusion criteria: * chronic infection * infection or co-infection with hiv-2