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

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ClinicalTrials.gov Identifier: NCT02976259
Recruitment Status : Not yet recruiting
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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)


Condition or disease Intervention/treatment Phase
HIV Infection Primary Drug: Dolutegravir Phase 3

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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)
Study Start Date : December 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976259


Contacts
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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

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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
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Dolutegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents