Clinical trial NCT02976259: Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection Primary
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

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)

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

Primary outcomes:
measure: Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
Secondary outcomes:
measure: The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid
timeFrame: Day 0 and 48 weeks
measure: Comparison of dolutegravir concentration in blood plasma and seminal fluid
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
measure: Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved
timeFrame: Day 0 and 12 weeks
Other outcomes:
Locations:
Study officials:
References: