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Completed

NCT Number: NCT02976259

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 : [email protected]

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)

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Key information

Conditions

HIV Infection Primary

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dolutegravir

Drug

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

Primary outcomes

  1. Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid

    Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks

    Measure of HIV-RNA level in blood plasma and seminal fluid at each point and comparaison about the decay between both

Secondary outcomes

  1. The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid

    Time frame: Day 0 and 48 weeks

  2. Comparison of dolutegravir concentration in blood plasma and seminal fluid

    Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks

    Measure of doltegravir concentration in blood and seminal fluid at each points and comparaison of the value between the 2 compartments

  3. Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved

    Time frame: Day 0 and 12 weeks

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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)

Acronym: DOLUPRIM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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