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

HIV Infection Primary Clinical Trial

— DOLUPRIM  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976259
• Other study ID #: IMEA 051
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dolutegravir
All patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid	Measure of HIV-RNA level in blood plasma and seminal fluid at each point and comparaison about the decay between both	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
Secondary	The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid		Day 0 and 48 weeks
Secondary	Comparison of dolutegravir concentration in blood plasma and seminal fluid	Measure of doltegravir concentration in blood and seminal fluid at each points and comparaison of the value between the 2 compartments	2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
Secondary	Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved		Day 0 and 12 weeks