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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)

I

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

Status and phase

Completed
Phase 3

Conditions

HIV Infection Primary

Treatments

Drug: Dolutegravir

Study type

Interventional

Funder types

Other

Identifiers

NCT02976259
IMEA 051

Details and patient eligibility

About

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)

Full 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)

Enrollment

20 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Patient HIV primary infection
Experimental group
Description:
HIV primary infection Patient male receiving Dolutegravir
Treatment:
Drug: Dolutegravir

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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