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

NCT02976259 | Completed Phase 3

• 1 other identifier: IMEA 051
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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)

Conditions

HIV Infection Primary

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks

Secondary Outcomes (3)

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

  Day 0 and 48 weeks

• 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

• 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

Study Arms (1)

Patient HIV primary infection

EXPERIMENTAL

HIV primary infection Patient male receiving Dolutegravir

Drug: Dolutegravir

Interventions

Dolutegravir DRUG

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

Patient HIV primary infection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chronic infection
• Infection or co-infection with HIV-2

Sponsors & Collaborators

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

MeSH Terms

Interventions

dolutegravir

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share