CompletedPhase 3

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

France101 participantsStarted 2017-04-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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 tria…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: week 48

Trial details

NCT IDNCT02987530

SponsorANRS, Emerging Infectious Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-07-30

View on ClinicalTrials.gov More HIV-1 Infection trials