Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection (DOLUPRIM)
Primary Purpose
HIV Infection Primary
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dolutegravir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection Primary
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient HIV primary infection
Arm Description
HIV primary infection Patient male receiving Dolutegravir
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid
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
Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved
Full Information
NCT ID
NCT02976259
First Posted
November 22, 2016
Last Updated
October 28, 2019
Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
1. Study Identification
Unique Protocol Identification Number
NCT02976259
Brief Title
Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection Primary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient HIV primary infection
Arm Type
Experimental
Arm Description
HIV primary infection Patient male receiving Dolutegravir
Intervention Type
Drug
Intervention Name(s)
Dolutegravir
Intervention Description
All patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples)
Primary Outcome Measure Information:
Title
Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid
Description
Measure of HIV-RNA level in blood plasma and seminal fluid at each point and comparaison about the decay between both
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
Secondary Outcome Measure Information:
Title
The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid
Time Frame
Day 0 and 48 weeks
Title
Comparison of dolutegravir concentration in blood plasma and seminal fluid
Description
Measure of doltegravir concentration in blood and seminal fluid at each points and comparaison of the value between the 2 compartments
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection
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