Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified November 2016 by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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


Information provided by (Responsible Party)
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier
NCT02976259

First received: November 22, 2016
Last updated: November 24, 2016
Last Verified: November 2016
History of Changes
Purpose

Purpose

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)

Condition Intervention Phase
HIV Infection Primary

Drug : Dolutegravir
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:

Primary Outcome Measures

  • 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 Outcome Measures:
  • The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid [ Time Frame: Day 0 and 48 weeks ]
  • 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
  • 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 ]

Estimated Enrollment: 20
Study Start Date: December 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Patient HIV primary infection
HIV primary infection Patient male receiving Dolutegravir
Drug: Dolutegravir

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

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

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: Male  
    Accepts Healthy Volunteers: No  

    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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02976259

    Contacts

    Contact:   Karine AMAT, MS +33.1.40.25.63.52 karine.amat@hotmail.fr

    Sponsors and Collaborators

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

    More Information


    Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba  
    ClinicalTrials.gov Identifier: NCT02976259   History of Changes  
    Other Study ID Numbers: IMEA 051  
    Study First Received: November 22, 2016  
    Last Updated: November 24, 2016  
    Individual Participant Data    
    Plan to Share IPD: No  

    Additional relevant MeSH terms:
    Infection
    Communicable Diseases
    HIV Infections
    Acquired Immunodeficiency Syndrome
    Dolutegravir

    ClinicalTrials.gov processed this data on December 15, 2017
    This information is provided by ClinicalTrials.gov.