HIV Infection PrimaryPhase 3DOLUPRIMNCT02976259
Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection
A Phase 3 study testing Dolutegravir in people with HIV Infection Primary, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infection Primary
- What is being tested?
- Dolutegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 3
- 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
- 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
Who cannot join
- Chronic infection
- Infection or co-infection with HIV-2
About this study
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)
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:
Read more
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)
Read the 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)
- Conditions
- HIV Infection Primary
- Being tested
- Dolutegravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
All patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples)
| Study group | Role | What they receive |
|---|---|---|
| Patient HIV primary infection | Experimental | HIV primary infection Patient male receiving Dolutegravir Receives: Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 0 and 48 weeks
Comparison of dolutegravir concentration in blood plasma and seminal fluid
Measure of doltegravir concentration in blood and seminal fluid at each points and comparaison of the value between the 2 compartments
Measured: 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
Measured: Day 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infection PrimaryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976259
- Sponsor's protocol ID
- IMEA 051
- Acronym
- DOLUPRIM
- Status last verified
- Aug 2019
- First submitted
- 22 Nov 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02976259
- Acronym / sponsor ID
- DOLUPRIM / IMEA 051
- Conditions
- HIV Infection Primary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
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)
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient HIV primary infection | Experimental | Drug: DolutegravirHIV primary infection Patient male receiving Dolutegravir |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Chronic infection
- Infection or co-infection with HIV-2
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 |
|---|---|---|
| DolutegravirAll patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples) | Drug | Patient HIV primary infection |
Primary outcome
Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid
Time frame: 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
3 secondary outcomes
The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid
Time frame: Day 0 and 48 weeks
Comparison of dolutegravir concentration in blood plasma and seminal fluid
Time frame: 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
Time frame: Day 0 and 12 weeks
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 30 Oct 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dolutegravir in people with HIV Infection Primary, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba.
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 4 inclusion and 2 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid (time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2019.