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

• Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba (Other)
• Overall Status: Completed
• CT.gov ID: NCT02976259
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Actual Duration (Months): 23

Study Details

Study Description

Brief Summary

Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue Henri Huchard - 75018 PARIS Tél. : [phone] - Fax : [phone]

Coordinating investigator:

Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses

1 avenue Claude Vellefaux - 75010 PARIS Tél. : [phone] - Fax : [phone] E-mail : [e-mail]

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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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)
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid [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 [Day 0 and 48 weeks]

2. Comparison of dolutegravir concentration in blood plasma and seminal fluid [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 [Day 0 and 12 weeks]

Eligibility Criteria

Criteria

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

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

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• ClinicalTrials.gov Identifier: NCT02976259
• Other Study ID Numbers: IMEA 051
• First Posted: Nov 29, 2016
• Last Update Posted: Oct 30, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Dolutegravir

Study Results

No Results Posted as of Oct 30, 2019