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

HIV Infection Primary Clinical Trial

Official title: Kinetics of HIV-RNA Decay in Seminal Plasma of Men Receiving a Dolutegravir-based Regimen at the Time of Primary HIV Infection (IMEA 051-DOLUPRIM Study)

Status Completed

Clinical Trial 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)

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection Primary
• HIV Infections
• Infection

• NCT number: NCT02976259
• Study type: Interventional
• Source: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Completion date: December 2018