Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection
Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection
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)
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