Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT04295460
Eligibility Criteria:
Inclusion Criteria:
* Treatment-naïve HIV-1-infected patients ≥ 18 years of age.
* Plasma HIV-1 RNA \>5000 and \<500.000 copies/ml.
* T lymphocyte CD4+ count in peripheral blood \>200/μl.
* Patients of childbearing age should consent to use a highly effective contraceptive method from 15 days before the time of inclusion of the study until 30 days after the end of it. It is considered a highly effective method:
* Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of Investigational Product, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
* Any intrauterine device with published data showing that the expected failure rate is \<1% per year (not all intrauterine devices meet this criterion)
* Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject.
* Approved hormonal contraception.
* Any other method with published data showing that the expected failure rate is \<1% per year.
* Signed written informed consent prior to inclusion.
Exclusion Criteria:
* Acute HIV infection
* T lymphocyte CD4+ count in peripheral blood ≤ 200/µl
* Active opportunistic infection.
* Pregnancy at inclusion or during the follow-up
* Active hepatitis C and/or B virus co-infection.
* ALT ≥ 5 times the ULN, or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with \>35% direct bilirubin).
* Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).
* Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
* Current or past disease that requires the use subsidiary of treatment with corticosteroids, immunomodulatory agents, interferon or chemotherapeutic agents.
* Any laboratory abnormality grade 3 or 4 according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (Annex 3)
* Concomitant use of drugs with potential major interactions with the prescribed drugs according to the respective full prescribing information.
* Estimated creatinine clearance \<50ml/min.
* History or presence of allergy to the study drugs or their components
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04295460
Study Brief:
Protocol Section:
NCT04295460