NCT02976259

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 Receiving a Dolutegravir-based Regimen at the Time of Primary HIV Infection (IMEA 051-DOLUPRIM Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue Henri Huchard - 75018 PARIS Tél. : [phone] - Fax : [phone] Coordinating investigator: Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses 1 avenue Claude Vellefaux - 75010 PARIS Tél. : [phone] - Fax : [phone] E-mail : [e-mail] 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)

Detailed 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)

Conditions

• HIV Infection Primary

Interventions

Type	Name	Description
DRUG	Dolutegravir	All patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples)

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-11-29
• Last updated: 2019-10-30