EUCTR2019-000812-27-FR
Active, not recruiting
Phase 1
Initiation of first-line antiretroviral treatment with TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the first clinical contact in France: Trial IMEA 055 – FAST - FAST
IMEA0 sites110 target enrollmentFebruary 19, 2019
ConditionsHIV positive age > 18 years -newly diagnosed HIV-infected individual evidenced by any tests -antiretroviral-treatment naive -negative urine pregnancy test -willing to sign an informed written consent– -regular health insurance -willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsBIKTARVY
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV positive age > 18 years -newly diagnosed HIV-infected individual evidenced by any tests -antiretroviral-treatment naive -negative urine pregnancy test -willing to sign an informed written consent– -regular health insurance -willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7
- Sponsor
- IMEA
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-age \> 18 years
- •\-newly diagnosed HIV\-infected individual evidenced by any of the following tests: (i) positive self\-test, (ii) positive HIV Rapid antibody test, (iii) positive HIV immunoassay (ELISA 4th generation) test
- •\-antiretroviral\-treatment naive
- •\-negative urine pregnancy test for women of childbearing potential and willing to use effective contraception (mechanical or medicamental)
- •\-willing to sign an informed written consent–
- •\-regular health insurance
- •\-willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •\-clinical symptoms suggestive of opportunistic infections
- •\-participant not willing to provide two distinct contact information
- •\-a woman who is pregnant or breast\-feeding or planning to become pregnant during the expected study period.
- •\-Co\-medication with deleterious interaction with study treatment (eg enzyme inducer)
Outcomes
Primary Outcomes
Not specified
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