AzTrials
AzTrials

HIV-1 InfectionPhase 3OPTIPRIM-2NCT02987530

National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection

A Phase 3 study testing Dolutegravir, Darunavir-cobicistat and Emtricitabine-Tenofovir in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the impact of two combination of two tablets once daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients with primary HIV-1 infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
Dolutegravir, Darunavir-cobicistat and Emtricitabine-Tenofovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteFrance
Study dates
11 Apr 2017to 31 Jan 2020
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at screening visit.
  • Patients with primary HIV-1 infection: Any results achieved in the previous 10 days of inclusion visit will be taken into account. If the Enzyme Linked ImmunoSorbent Assay (ELISA) test result does not dissociate the signals antibodies and p24 antigen or in case of rapid test result :
  • Negative ELISA / rapid test and positive HIV-1 RNA confirmed by a second positive HIV-1 RNA.
  • Positive ELISA / rapid test and WB-HIV1 [0-5] band (s) or IB-HIV-1 [0-3] band(s) confirmed by a positive HIV-1 RNA.
  • If the ELISA test result dissociated p24 antigen and antibodies signals:
  • ELISA Ac - / p24 - and positive HIV-1 RNA confirmed by a second positive HIV-1 RNA.
Show all 12Show fewer
  • ELISA Ac - / p24 + confirmed by a positive HIV-1 RNA.
  • ELISA Ac + / p24 + or - and WB-HIV1 [0-5] band (s) or IB-HIV-1 [0-3] band(s) confirmed by a positive HIV-1 RNA.
  • Written informed consent signed by the person and the investigator no later than the day of the screening visit and before any exam performed in the trial (article L1122-1-1 Public Health Code).
  • Affiliate or beneficiary of a social security system (Article L1121-11 of the Public Health Code) (the State Medical Aid or AME is not a social security system).
  • Patients followed in selected centers, accepting additional constraints and having signed a consent, will participate to virological, immunological and pharmacological sub-studies.
  • Patient agreeing to participate in the trial for 1 year according to the defined terms.

Who cannot join

  • Any antiretroviral treatment (for Pre-Exposure Prohylaxis or Post-exposure prophylaxis) during the 4 weeks preceding inclusion.
  • Associated pathology with urgent care needed.
  • Prothrombin Ratio < 50%.
  • Creatinine clearance < 70 mL / min (Cockroft).
  • aspartate transaminase (AST), alanine transaminase (ALT), or bilirubin (total and conjugated) ≥ 10 times the upper limit of normal.
  • Patient with isolated HIV-2 viral strain.
Show all 16Show fewer
  • Women of childbearing potential without effective contraception method (see appendix A6).
  • Pregnant or breastfeeding women.
  • Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
  • Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
  • Planned absence which could prevent optimal trial participation (vacation abroad, moving, imminent job change ...).
  • Co-administration of prohibited treatments (see § 9.5).
  • History or presence of allergy to the study drugs or their components;
  • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
  • Any symptoms or laboratory values suggesting a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or other medical conditions that could interfere with the interpretation of trial results or compromise the health of patients.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Bicetre

    All the Regions of the Country (40 Centers)

Other trials in France

About this study

Official title: Phase III Multicenter Randomized Trial Evaluating in Patients at the Time of the Primary HIV-1 Infection, the Impact on the Viral Reservoir of a Combination Including Tenofovir/Emtricitabine and Dolutegravir or Tenofovir/Emtricitabine and Darunavir/Cobicistat

The purpose of this study is to compare the impact of two combination of two tablets once daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients with primary HIV-1 infection.

Read the detailed description

Phase III, randomized (1: 1), comparative, superiority, open-label, parallel assignment, national multicenter trial evaluating two treatments in patients with primary HIV-1 infection.

Comparison of the two combinations regarding:

  • Viral reservoir at W48
  • Early inhibition of viral replication,
  • Plasmatic and cellular cumulative viremia at W48,
  • Immune reconstitution with CD4, CD8 levels and CD4 / CD8 ratio,
  • Activation parameters decrease,
  • Adherence to treatments,
  • Treatments tolerance,
  • Adverse events,
  • Quality of life (by self-administered questionnaires). Study of the pharmacokinetics / dynamics relationship of the decay of plasma, cellular and spermatic compartments' viral loads. 50 participants per group will be enrolled in 40 sites in France. Co- inclusion in ANRS CO 06 PRIMO cohort will be offered
Conditions
HIV-1 Infection
Being tested
Dolutegravir, Darunavir-cobicistat, Emtricitabine-Tenofovir
Keywords
primary infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DolutegravirDrug

    Also called Tivicay

    Oral use, 50mg/day

  • Darunavir-cobicistatDrug

    Also called Rezolsta

    Oral use, 800-150mg/day

  • Emtricitabine-TenofovirDrug

    Also called Truvada

    Oral use, Emtricititabine : 200mg/day Ténofovir : 245mg

Study groups in NCT02987530
Study groupRoleWhat they receive
Dolutegravir + Emtricitabine/TenofovirExperimentalPatients will take Dolutegravir 50 mg (= Tivicay, 1 tablet per day) with Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks
Receives: Drug: Dolutegravir; Drug: Emtricitabine-Tenofovir
Darunavir/Cobicistat + Emtricitabine/TénofovirActive comparatorPatients will take Darunavir 800 mg / Cobicistat 150 mg (=Rezolsta, 1 tablet per day) + Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks
Receives: Drug: Darunavir-cobicistat; Drug: Emtricitabine-Tenofovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV-DNA levels in the peripheral blood mononuclear cell (PBMC) at week 48

    Measured: week 48

Secondary outcomes (23)

  1. Cumulative cellular viremia up to week 48

    Measured: week 48

  2. Cumulative plasmatic viremia (HIV-1 RNA) at week 48

    Measured: week 48

  3. Cumulative plasmatic viremia using the values obtained by ultrasensitive quantification for all HIV-1-RNA values < 50 copies / mL.

    Measured: week 48

  4. Levels of HIV-1 RNA in plasma at week 2, week 4, week 8, week 12, week 24, week 36, week 48 and changes between week 0 and week 48

    Measured: week 2, week 4, week 8, week 12, week 24, week 36, week 48

  5. Percentage of patients with HIV-1 RNA <50 copies / mL at week 2, week 4, week 8, week 12, week 24, week 36, week 48

    Measured: week 2, week 4, week 8, week 12, week 24, week 36, week 48

  6. Proportion of patients with HIV-1-RNA plasma below the ultrasensitive technique quantification threshold at week 2, week 4, week 8, week 12, week 24, week 36 and week 48

    Measured: week 2, week 4, week 8, week 12, week 24, week 36 and week 48

  7. Total DNA-HIV levels measured in PBMC at week 2, week 4, week 8, week 12, week 24, week 36 and week 48

    Measured: week 2, week 4, week 8, week 12, week 24, week 36 and week 48

  8. Total DNA-HIV levels measured in PBMC: changes between week 0 and week 48.

    Measured: between week 0 and week 48

  9. CD4 and CD8 counts and percentage at week 2, week 4, week 8, week 12, week 24, week 36, week 48.

    Measured: week 2, week 4, week 8, week 12, week 24, week 36, week 48

  10. CD4 and CD8 counts and percentage changes between week 0 and week 48.

    Measured: between week 0 and week 48.

  11. CD4/CD8 ratio at week 2, week 4, week 8, week 12, week 24, week 36, week 48.

    Measured: week 2, week 4, week 8, week 12, week 24, week 36, week 48

  12. CD4/CD8 ratio changes between week 0 and week 48.

    Measured: between week 0 and week 48.

  13. Pharmacokinetic: mean concentrations between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease.

    Measured: between week 0 and week 48

  14. Pharmacokinetic: cumulative AUC between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease.

    Measured: between week 0 and week 48

  15. Trial treatments tolerance using self-administered questionnaires of symptoms experienced.

    Measured: week 0, week 4, week 8, week 12, week 24, week 36 and week 48

  16. Reported quality of life using self-administered questionnaire (PROQOL-HIV questionnaire).

    Measured: between week 0 and week 48

  17. Number, nature and time of occurrence of stage 3 or 4 clinical and biological adverse events (using ANRS scale to grade severity of adverse events in adults).

    Measured: between week 0 and week 48

  18. HIV infection progression defined by occurrence of B or C stage clinical events or death between week 0 and week 48

    Measured: between week 0 and week 48

  19. Evolution of Metabolic disorders assessed by measurement of cholesterol, triglycerides, blood glucose and lipase

    Measured: between week 0 and week 48

  20. Evolution of Renal function assessed by urea and serum creatinine.

    Measured: between week 0 and week 48

  21. Adherence to treatments using self-administered questionnaires

    Measured: week 4, week 8, week 12, week 24, week 36 and week 48

  22. Adherence to treatments using pills' counts by local pharmacist

    Measured: week 4, week 8, week 12, week 24 and week 36

  23. Adherence to treatments using MEMS (Medical Event Monitoring System) data collected during the first 3 months

    Measured: between week 0 and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2016 (estimated)
  2. Study start11 Apr 2017
  3. Primary completion30 Jul 2019
  4. Study completion31 Jan 2020

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02987530
Sponsor's protocol ID
ANRS 169 OPTIPRIM-2
Other IDs
2016-001683-11, 2016
Acronym
OPTIPRIM-2
Status last verified
Aug 2019
First submitted
30 Nov 2016
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cheret A, Bauer R, Meiffredy V, Lopez P, Ajana F, Lacombe K, Morlat P, Lascoux C, Reynes J, Calin R, Abel S, Goujard C, Rouzioux C, Avettand-Fenoel V, Meyer L. Once-daily dolutegravir versus darunavir plus cobicistat in adults at the time of primary HIV-1 infection: the OPTIPRIM2-ANRS 169 randomized, open-label, Phase 3 trial. J Antimicrob Chemother. 2022 Aug 25;77(9):2506-2515. doi: 10.1093/jac/dkac207.

    PubMed 35762503

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dolutegravir, Darunavir-cobicistat and Emtricitabine-Tenofovir in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 1 site 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 12 inclusion and 16 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 7 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 1 site 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.

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?

HIV-DNA levels in the peripheral blood mononuclear cell (PBMC) at week 48 (time frame: week 48). 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 NCT02987530, 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 7 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in