National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficie… (NCT02987530) | Clinical Trial Compass
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 range18 Years
SexALL
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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…
What they're measuring
1
HIV-DNA levels in the peripheral blood mononuclear cell (PBMC) at week 48