Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors Backbone

NCT04133012 | Completed

• 1 other identifier: ANRS EP64 DOLUVOIR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

Brief Summary

The main objective of the study is to characterize the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.

Conditions

HIV-1 Infection

Keywords

Viral cartography; Viral reservoir; Antiretroviral treatments diffusion

Outcome Measures

Primary Outcomes (4)

• Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in sperm

  Dosage of the different antiretroviral drugs molecules in sperm

  At Day 0, At time T0 (before taking treatments)

• Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in lymph nodes

  Dosage of the different antiretroviral drugs molecules in lymph nodes

  At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)

• Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in fat tissues

  Dosage of the different antiretroviral drugs molecules in fat tissues

  At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)

• Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in rectal tissues

  Dosage of the different antiretroviral drugs molecules in rectal tissues

  At Day 0, T1 (maximum 3 hours after taking treatment)

Secondary Outcomes (4)

• Characterization of the level of the replication (RNA-HIV) and the level of infection (DNA-HIV) in the reservoirs

  At Day 0

• Study of the spatial dynamics of viral quasi-species In the different reservoirs

  At Day 0

• Study of the mutations of resistance in the integrase gene

  At Day 0

• Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication

  At Day 0

Study Arms (1)

Single Arm

OTHER

Single arm composed by 34 HIV-1 infected male subjects

Other: Samplings

Interventions

Samplings OTHER

* blood samples * rectal biopsies * nodes biopsies * cutaneous fat tissues biopsies * semen sample

Single Arm

Eligibility Criteria

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

You may qualify if:

• Male HIV-1 infected subjects
• Age \> or = 18 years old
• Currently receiving as first line therapy 7 days a week for at least 18 months with dolutegravir (at 50 mg once a day) and two nucleoside/nucleotide reverse transcriptase inhibitors (abacavir/lamivudine or ,tenofovir/emtricitabine) or
• Receiving first-line therapy 7 days a week for at least 18 months with dolutegravir (50 mg once daily) + abacavir/lamivudine followed by dual therapy with dolutegravir + lamivudine for at least 6 months; or
• Receiving first-line therapy 7 days a week for at least 18 months with dolutegravir + tenofovir / emtricitabine followed by dual therapy with dolutegravir + lamivudine for at least 6 months.
• HIV RNA currently \<50 Cp/mL, , and \<50 Cp/mL 6 months after treatment initiation and \<50 Cp/mL confirmed at 12 months after treatment initiation
• Normal PT, APTT and platelet count values at screening
• Written and informed consent signed by the person and the investigator (no later than the day of pre-enrollment and prior to any examination carried out as part of the study (article L1122-1-1 of the Public Health Code)
• Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (State Medical Aid or AME is not a social security scheme)

You may not qualify if:

• Single HIV-2 infection
• Dolutegravir antiretroviral monotherapy
• Contraindication to biopsy, taking anticoagulant and antiplatelet drugs
• Hemophilia
• Symptomatic sexually transmitted infection
• Being under guardianship or trusteeship mandate for future protection
• Participation in another research involving the human person, of category 1 or 2,
• Associated treatments (Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital, Rifampicin, St. John's Wort)

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• ViiV Healthcare: collaborator

Study Sites (8)

Antoine-Beclere Hospital

Clamart, France

Location

Bicetre Hospital

Le Kremlin-Bicêtre, France

Location

Saint Antoine Hospital

Paris, 75012, France

Location

Bichat Hospital

Paris, France

Location

Hotel Dieu Hospital

Paris, France

Location

Necker Hospital

Paris, France

Location

Pitie Salpetriere Hospital

Paris, France

Location

Tourcoing Hospital

Tourcoing, 59208, France

Location

Related Publications (1)

• Mchantaf G, Melard A, Da Silva K, Gardiennet E, Chaillon A, Lefebvre B, Ghosn J, Robineau O, Viard JP, Adoux L, Lemoine F, Barrail-Tran A, Orr S, Coulibaly F, Meyer L, Cheret A, Avettand-Fenoel V. HIV persistence in tissues on dolutegravir-based therapy is not associated with resistance mutations to dolutegravir. Commun Med (Lond). 2026 Jan 27;6(1):130. doi: 10.1038/s43856-026-01405-z.

  PMID: 41593349 RESULT

Related Links

• Related Info

Study Officials

• Antoine CHERET

  CHU Pointe-à-Pitre/Abymes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 21, 2019
• Study Start: February 10, 2020
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: April 13, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)