HIV-1 InfectionDOLUVOIRNCT04133012
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
A study testing Samplings in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Samplings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesFrance
- Study dates
- 10 Feb 2020to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Antoine-Beclere Hospital
Clamart
Bicetre Hospital
Le Kremlin-Bicêtre
Saint Antoine Hospital
Paris, 75012
Bichat Hospital
Paris
Hotel Dieu Hospital
Paris
Necker Hospital
Paris
Pitie Salpetriere Hospital
Paris
Tourcoing Hospital
Tourcoing, 59208
About this study
Official title: A Prospective Study Aiming to Determine the Cartography of Virological Reservoir Related to Antiretroviral Concentrations in Chronic HIV-1 Patients Treated With a First Line of Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors (NRTIs).
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.
Read the detailed description
The major obstacle to a functional cure of HIV infection is the persistence of the latent HIV reservoir.
Several arguments suggest the persistence of a residual viral replication in different compartments, despite an effective antiretroviral treatment. This residual viral replication partially comes from pharmacological sanctuaries where the drugs do not largely penetrate. In such sanctuaries a recent report published in Nature has shown that the virus can replicate with less antiviral pressure contributing to continuously replenish the reservoirs. Nevertheless, this study concerned a limited number of patients and only blood and lymph-node samples were collected for viral analysis. Moreover, the drug distribution was estimated based on mathematical hypotheses without drug measure concentration.
The International AIDS Society recommend for most patients an optimal initial regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI)2. The new integrase inhibitor dolutegravir is more and more widely used in combination with nucleoside/nucleotide reverse transcriptase. Indeed, this drug shows a good tolerance and demonstrates a particularly fast inhibition of the viral replication. Moreover, dolutegravir is active against HIV strains that are resistant to the first generation of integrase inhibitors, raltegravir and elvitegravir. However the penetration of dolutegravir in deep compartments has not been fully characterized: the studies comprised a small number of patients and were not able to estimate the distribution in several compartments at the same time for each patient. Moreover the levels of residual viral replication in those compartments during treatment are unknown, making it difficult to evaluate the capacity of this drug and associated backbone to efficiently act against viral reservoirs maintenance.
The aim of the study is to measure simultaneously dolutegravir and nucleoside/nucleotide reverse transcriptase inhibitors in different compartments to obtain cartography of dolutegravir and associated backbone distribution and the spatial dynamics of virus in each patient.
The decision to study dolutegravir and the two associated backbones (abacavir / lamivudine or tenofovir /emtricitabine) was decided as:
- The International AIDS Society recommend for most patients an optimal initial regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI)2.
- Dolutegravir viral power is established for high levels of viral load 90 and this drug is widely used.
- This study is very complementary of studies ANRS SIVART and ANRS 169 OPTIPRIM 2.
- Dolutegravir is combined with abacavir + lamivudine in a single-tablet and is largely prescribed.
- Raltegravir and elvitegravir will not be analysed because the number of recruited patients should be more important to obtain sufficient data and the feasibility would not be sure.
- Conditions
- HIV-1 Infection
- Being tested
- Samplings
- Keywords
- Viral cartography, Viral reservoir, Antiretroviral treatments diffusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingsOther
- blood samples
- rectal biopsies
- nodes biopsies
- cutaneous fat tissues biopsies
- semen sample
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single arm composed by 34 HIV-1 infected male subjects Receives: Other: Samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Analyze and comparison of the level of viral transcription by measuring the cell-associated HIV- RNA in the different tissues and fluids: lymphoid, rectal, genital secretion, blood and fat biopsies as well as cerebrospinal fluid. Analyze and comparison of the reservoir level by measuring the cell-associated total HIV- DNA in the different tissues and fluids
Measured: At Day 0
Study of the spatial dynamics of viral quasi-species In the different reservoirs
Analyze of the spatial dynamics of HIV-DNA and HIV-RNA from Lymphoid, rectal, genital secretion, blood, fat cells by phylogenetic analyses after sequencing Env HIV-DNA and HIV-RNA
Measured: At Day 0
Study of the mutations of resistance in the integrase gene
Description of resistance mutations in Integrase gene which could be linked to suboptimal concentrations of dolutegravir
Measured: At Day 0
Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication
Characterization of the relationship between the concentration of dolutegravir and backbone drugs with the level of wild type viral replication in the different compartments. Analyze of the impact of backbone drugs associated to dolutegravir on viral level production. Correlation between the level of resistant virus replication and the exposure to dolutegravir and the backbone drugs. Evaluation by simulation the effect of different dosing regimen of dolutegravir (including higher doses) on the level of viral replication and on resistance
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start10 Feb 2020
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Antoine CHERET, Principal investigator, CHU Pointe-à-Pitre/Abymes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133012
- Sponsor's protocol ID
- ANRS EP64 DOLUVOIR
- Acronym
- DOLUVOIR
- Status last verified
- Aug 2023
- First submitted
- 26 Sep 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41593349
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Aiming to Determine the Cartography of Virological Reservoir Related to Antiretroviral Concentrations in Chronic HIV-1 Patients Treated With a First Line of Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors (NRTIs).
- ClinicalTrials.gov ID
- NCT04133012
- Acronym / sponsor ID
- DOLUVOIR / ANRS EP64 DOLUVOIR
- Conditions
- HIV-1 Infection
- Keywords
- Viral cartography, Viral reservoir, Antiretroviral treatments diffusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- ViiV Healthcare
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The major obstacle to a functional cure of HIV infection is the persistence of the latent HIV reservoir.
Several arguments suggest the persistence of a residual viral replication in different compartments, despite an effective antiretroviral treatment. This residual viral replication partially comes from pharmacological sanctuaries where the drugs do not largely penetrate. In such sanctuaries a recent report published in Nature has shown that the virus can replicate with less antiviral pressure contributing to continuously replenish the reservoirs. Nevertheless, this study concerned a limited number of patients and only blood and lymph-node samples were collected for viral analysis. Moreover, the drug distribution was estimated based on mathematical hypotheses without drug measure concentration.
The International AIDS Society recommend for most patients an optimal initial regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI)2. The new integrase inhibitor dolutegravir is more and more widely used in combination with nucleoside/nucleotide reverse transcriptase. Indeed, this drug shows a good tolerance and demonstrates a particularly fast inhibition of the viral replication. Moreover, dolutegravir is active against HIV strains that are resistant to the first generation of integrase inhibitors, raltegravir and elvitegravir. However the penetration of dolutegravir in deep compartments has not been fully characterized: the studies comprised a small number of patients and were not able to estimate the distribution in several compartments at the same time for each patient. Moreover the levels of residual viral replication in those compartments during treatment are unknown, making it difficult to evaluate the capacity of this drug and associated backbone to efficiently act against viral reservoirs maintenance.
The aim of the study is to measure simultaneously dolutegravir and nucleoside/nucleotide reverse transcriptase inhibitors in different compartments to obtain cartography of dolutegravir and associated backbone distribution and the spatial dynamics of virus in each patient.
The decision to study dolutegravir and the two associated backbones (abacavir / lamivudine or tenofovir /emtricitabine) was decided as:
- The International AIDS Society recommend for most patients an optimal initial regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI)2.
- Dolutegravir viral power is established for high levels of viral load 90 and this drug is widely used.
- This study is very complementary of studies ANRS SIVART and ANRS 169 OPTIPRIM 2.
- Dolutegravir is combined with abacavir + lamivudine in a single-tablet and is largely prescribed.
- Raltegravir and elvitegravir will not be analysed because the number of recruited patients should be more important to obtain sufficient data and the feasibility would not be sure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Other: SamplingsSingle arm composed by 34 HIV-1 infected male subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- Single HIV-2 infection
- Dolutegravir antiretroviral monotherapy
- Contraindication to biopsy, taking anticoagulant and antiplatelet drugs
- Hemophilia
- Symptomatic sexually transmitted infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samplings* blood samples * rectal biopsies * nodes biopsies * cutaneous fat tissues biopsies * semen sample | Other | Single Arm |
Primary outcome
Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in sperm
Time frame: At Day 0, At time T0 (before taking treatments)
Dosage of the different antiretroviral drugs molecules in sperm
Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in lymph nodes
Time frame: At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
Dosage of the different antiretroviral drugs molecules in lymph nodes
Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in fat tissues
Time frame: At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
Dosage of the different antiretroviral drugs molecules in fat tissues
Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in rectal tissues
Time frame: At Day 0, T1 (maximum 3 hours after taking treatment)
Dosage of the different antiretroviral drugs molecules in rectal tissues
4 secondary outcomes
Characterization of the level of the replication (RNA-HIV) and the level of infection (DNA-HIV) in the reservoirs
Time frame: At Day 0
Study of the spatial dynamics of viral quasi-species In the different reservoirs
Time frame: At Day 0
Study of the mutations of resistance in the integrase gene
Time frame: At Day 0
Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication
Time frame: At Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 41593349Mchantaf 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine CHERET principal investigator
CHU Pointe-à-Pitre/Abymes
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samplings in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in sperm (time frame: At Day 0, At time T0 (before taking treatments)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.